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O R I G I N A L P A P E R

The Impact of Prolonged Exposure on PTSD Symptoms and Associated Psychopathology in People Living with HIV: A Randomized Test of Concept

Maria L. Pacella • Aaron Armelie • Jessica Boarts •

Glenn Wagner • Tracy Jones • Norah Feeny •

Douglas L. Delahanty

Published online: 20 October 2011

� Springer Science+Business Media, LLC 2011

Abstract People living with HIV (PLWH) report elevated

levels of posttraumatic stress disorder symptoms (PTSS) and

associated comorbidities. The present study tested the effi-

cacy of prolonged exposure (PE) at reducing PTSS,

depression, negative posttraumatic cognitions, and sub-

stance use in PLWH. Participants were randomly assigned to

receive PE (n = 40) or to a weekly monitoring control group

(n = 25). Assessments occurred at baseline, post-interven-

tion and 3-months post-treatment. Following the 3-month

assessment, controls were offered the intervention. All PE

recipients (whether originally from the PE or control group)

completed a 6-month assessment. Intent-to-treat mixed

model repeated measures ANOVAs were conducted through

3-months post-treatment; within group analyses were con-

ducted through 6-months. PE recipients reported fewer PTSS

and negative posttraumatic cognitions and were more likely

to achieve good end-state functioning; gains were

maintained at 6-months. No between-group differences

emerged for substance use. Overall, results support the

efficacy of PE in PLWH.

Keywords People living with HIV � Prolonged exposure � Posttraumatic stress disorder � Depression � Intervention

Resumen Las personas que viven con VIH (PLWH por

sus siglas en inglés) presentan niveles elevados de los

sı́ntomas de trastorno de estrés postraumático (TEPT) y

las comorbilidades asociadas. En el estudio actual se

examinó la eficacia de la exposición prolongada (EP) por

la reducción de TEPT, la depresión, las cogniciones

postraumáticas negativas, y el uso de sustancias en

PLWH. Los participantes fueron asignados de manera

aleatoria a recibir la EP (n = 40), o a un grupo control

con supervisión semanal (n = 25). Las evaluaciones fu-

eron realizadas a la lı́nea base, después de la interven-

ción, y a los 3 meses después del tratamiento. Terminada

esta última evaluación, se les ofreció la intervención a

los miembros del grupo de control. Todos los receptores

de la EP (sean originalmente miembros del grupo EP o

del control) completaron una evaluación a los 6 meses.

Se realizaron los ANOVAs de medidas repetidas y

modelos mixtos por intención de tratamiento hasta los 3

meses después del tratamiento; los análisis dentro del

grupo se llevaron a cabo hasta los 6 meses. Los re-

ceptores de la EP mostraron menos sı́ntomas de TEPT y

cogniciones postraumáticas negativas, y tuvieron más

probabilidad de lograr buen funcionamiento en el estado

final; los beneficios se mantenı́an a los 6 meses. No hubo

diferencias entre los grupos en cuanto al uso de su-

stancias. En general, los resultados apoyan la eficacia de

la EP en PLWH.

M. L. Pacella � A. Armelie � J. Boarts � D. L. Delahanty (&) Department of Psychology, Kent State University, 118 Kent

Hall, Kent, OH 44242, USA

e-mail: [email protected]

G. Wagner

The RAND Corporation, Santa Monica, CA, USA

T. Jones

The AIDS Taskforce of Greater Cleveland, Cleveland, OH, USA

N. Feeny

Case Western Reserve University, Cleveland, OH, USA

D. L. Delahanty

Department of Psychology in Psychiatry, Northeastern Ohio

Universities College of Medicine (NEOUCOM), Rootstown,

OH, USA

123

AIDS Behav (2012) 16:1327–1340

DOI 10.1007/s10461-011-0076-y

Palabras claves personas que viven con VIH � exposición prolongada � trastorno de estrés postraumático � depresión � intervención

Introduction

With the publication of the fourth edition of the Diagnostic

and Statistical Manual of Mental Disorders (DSM-IV) [1],

diagnosis with a life-threatening or terminal disease was

first recognized as a traumatic event that could lead to the

development of posttraumatic stress disorder (PTSD).

Since then, research has established that PLWH report

some of the highest rates of PTSD observed for any

medical trauma/diagnosis population (e.g., cancer patients,

myocardial infarction, cardiac surgery, stroke, childbirth,

miscarriage, abortion, etc.) [2]. Between 30 and 61% of

PLWH develop HIV-related PTSD at some point in their

lives from either a diagnosis of HIV, or from other issues

related to the disease [3–6]. In addition, PLWH report

disproportionately high levels of nonHIV-related traumatic

experiences (i.e., childhood sexual and physical abuse,

sexual assaults, parental neglect [7–9]), and rates of PTSD

in general (from either HIV- or nonHIV-related events)

ranging from 14 to 61% [3, 4, 10–13]. These percentages

are significantly higher than reported rates of PTSD in the

general population (7–10%) [14, 15].

To receive a diagnosis of PTSD, an individual must

react with intense fear, helplessness, or horror after expo-

sure to a traumatic event that involved actual or threatened

death to oneself or others. Additionally, PTSD involves a

host of symptoms generally categorized in the following

three clusters: reexperiencing, avoidance and numbing, and

hyperarousal [1]. Individuals who suffer from PTSD also

display heightened risk of comorbid disorders (e.g.,

depression, anxiety) [14, 16, 17], suicidal ideation [17],

impaired psychosocial functioning [18, 19], physical health

complications [20, 21], and poor quality of life [21]. In

addition, individuals with PTSD often have negative

posttraumatic cognitions, such as negative thoughts about

the self and the world, and self blame [22, 23].

PTSD may be particularly detrimental to PLWH;

research has suggested that the course of HIV infection is

susceptible to influence by psychosocial factors including

PTSD [24]. It has been suggested that the presence of

traumatic stress and depression may explain some of the

variability in HIV disease course [24–29]. Both PTSD and

depression have been associated with lower CD4/CD8 cell

count ratios [12, 30], and HIV-related PTSD specifically

has been associated with greater reporting of physical

symptoms [31]).

PTSD may also indirectly impact disease course in

PLWH through several mechanisms. PTSD symptoms of

avoidance may lead PLWH to not adhere to medication

regimens or to miss more doctors’ appointments, as both of

these events serve as reminders of their diagnosis [32, 33].

Avoidance symptoms may also prevent individuals from

disclosing their HIV status to significant others (i.e., friends

or sexual partners), which may have serious implications

for the spread of the disease [33].

PTSD rarely occurs in a ‘‘pure’’ form and is often

comorbid with depression; rates of PTSD/depression

comorbidity range from 35 to 50% [14, 29, 34–36].

Depression has been associated with faster HIV disease

progression [14, 29, 37–39] and three times the risk of

nonadherence to medical treatment regimens in a variety of

medically ill populations [40]. Though it is difficult to

isolate the unique effects of PTSD and depression on dis-

ease progression and adherence due to the high rates of

comorbidity, results from a recent cross-sectional study

revealed that depressive symptoms (as compared to PTSD

symptoms and comorbid symptomology) had the strongest

relationship to CD4 cell counts and medication adherence

[41]. Similarly, Boarts and colleagues [37] found that both

PTSD and depression were associated with low medication

adherence, but that depression, and not PTSD, predicted

lower CD4 cell counts and higher viral load.

Substance use is also commonly comorbid with PTSD.

PTSD rates range from 30 to 50% in substance abusers

[42], and comorbidity rates of substance abuse/dependence

in PTSD are high (up to 43%) [14, 43–46]. Further, HIV is

associated with increased risk for substance use disorders,

as alcohol and substance use disorders are between 2.5 and

7.5 times more prevalent in PLWH than in the general

population [7]. Substance use alone is independently

associated with faster disease progression, less than opti-

mal medication adherence, failure of HAART medication

regimens, and immune suppression [30, 47, 48], and

comorbid PTSD/substance use is associated with a greater

decline in immune function and health status [11, 49, 50].

Taken together, PTSD, depression, and substance use

independently and collectively confer a detrimental effect

on HIV disease course, adherence to medication regimens,

and negative health behaviors [30, 51].

Given the high incidence of post-traumatic distress and

the negative consequences of PTSD and comorbid disor-

ders, PLWH are in need of effective mental health inter-

ventions [9, 24, 52, 53]. Despite the demonstrated efficacy

of psychotherapeutic interventions for depression [54–56],

the majority of mental health needs, specifically regarding

PTSD, are unmet in PLWH [9]. In a sample of female HIV

patients seeking medical care, Martinez and colleagues [4]

estimated that 78% of women with partial PTSD and 59%

of women with full PTSD were not receiving treatment for

their disorder. Additionally, Israelski and colleagues [57]

reported that 43% of patients recruited from a primary care

1328 AIDS Behav (2012) 16:1327–1340

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services system who met criteria for either depression,

PTSD, or acute stress disorder were not being treated.

Prolonged Exposure Therapy

Prolonged exposure (PE) therapy, a form of cognitive-

behavioral therapy, is considered the most appropriate first-

line PTSD treatment [58–60]. To date, PE is the only

empirically supported evidence-based treatment available

for individuals with PTSD [61]. Research has demonstrated

the efficacy of PE for the treatment of PTSD and comorbid

symptoms across several controlled studies with varied

trauma samples (for a review, see Powers and colleagues

[62]). Recent research has suggested that the treatment of

PTSS in substance-using individuals may consequently

result in decreases in substance use, and PE may be ben-

eficial for those who are substance dependent [63]. Further,

in a recent state-of-the-science review, Nemeroff and col-

leagues [64] reported that the Substance Abuse and Mental

Health Services Administration recommends PE for

national dissemination, as it represents a model program

for PTSD treatment. The superior efficacy of PE (as

compared to cognitive restructuring and the combination of

cognitive restructuring and PE) at producing improvements

in good end-state functioning was also cited [64].

PE involves repeated imaginal exposure to the traumatic

event (trauma reliving) and repeated in vivo exposure to

situations encountered in daily life that may be avoided due

to the traumatic memory or PTSS [65]. Through habitua-

tion, the traumatic memory becomes incorporated into

normal cognitive schemas which then prevent generaliza-

tion of the traumatic memory to safe situations [66]. PE

also involves systematic repeated confrontation with trau-

matic memories that serve to disconfirm negative post-

traumatic cognitions [22]. PE therapy has been found to be

just as effective at reducing negative posttraumatic cogni-

tions, depression, and general anxiety as PE combined with

cognitive restructuring in a sample of adult female assault

victims [22]. Despite the high rates of PTSD in PLWH, and

the demonstrated efficacy of PE therapy in individuals with

PTSD, no study to date has examined the efficacy of PE for

PTSD in a sample of PLWH.

The present study aimed to test the efficacy of PE

therapy at reducing PTSD symptoms in male and female

PLWH in a small randomized controlled trial design.

Further, given the lack of evidence concerning efficacious

treatments for PTSD stemming from diagnosis/living with

HIV, we assessed the efficacy of PE at decreasing PTSD

symptoms both from HIV- and nonHIV-related traumas.

We hypothesized that HIV- and nonHIV-related PTSS,

depression symptoms, negative posttraumatic cognitions,

and substance use would decrease over time for PE

recipients. It was also hypothesized that participants

receiving PE therapy would report significantly fewer

PTSD symptoms regarding both HIV- and nonHIV-related

trauma compared to the control group. Further, we

hypothesized that the PE group would report fewer

depression symptoms, fewer negative posttraumatic cog-

nitions, and lower levels of substance use than the control

group. Additionally, we hypothesized that a higher per-

centage of PE versus control participants would meet cri-

teria for good end-state functioning.

Method

Participants

PLWH were recruited between 2005 and 2008 from two

social service agencies near Cleveland, OH. Ninety-nine

adult PLWH were screened to determine eligibility for the

study. Participants were eligible if they were fluent in

English, met criteria for a likely diagnosis of PTSD as

assessed through the self-report PTSD Diagnostic Scale

(PDS [67]) and were currently taking antiretroviral medi-

cations for HIV. Exclusionary criteria included diagnosis

of a psychotic disorder, current or previous diagnosis of

schizophrenia, and current suicidal ideation. Of the 99

PLWH screened, 34 did not meet requirements for the

study (see Fig. 1 for a flow diagram of participant pro-

gress). Thus, 65 (24 females and 41 males) eligible par-

ticipants completed the baseline questionnaires. The

sample at baseline consisted of 29 (44.6%) African

Americans, 25 (38.5%) Caucasians, 4 (6.1%) Hispanics,

and 7 (10.8%) individuals who identified with more than

one race. The mean age was 46 years (range 31–61). Par-

ticipants had been living with a diagnosis of HIV for

approximately 13 years (range 13 months–26 years) and

were a low income sample, with 85% (n = 55) of the

participants earning below 20,000 dollars annually.

Thirty-four participants were randomly assigned to the

PE treatment group, while 24 were assigned to the weekly

monitoring control group. At the post-intervention assess-

ment, 23 participants were retained in the PE group (32%

drop-out rate) and 24 participants were retained in the

control group (0% drop-out rate). At the 3-month follow-up

19 PE recipients were retained as were all the control

participants.

After completion of the 3-month assessment, participants

in the control group were given the opportunity to partici-

pate in the intervention; nineteen chose to receive the

intervention. All participants receiving PE (whether they

had originally been in the control group or not) were

assessed at 6-months post-intervention. Seventeen of the

original PE participants were retained throughout 6-months

(two participants lost to follow-up between 3-and 6-months)

AIDS Behav (2012) 16:1327–1340 1329

123

and 13 (68.4% retention rate) of the original nineteen con-

trol participants who opted to receive the intervention were

retained throughout the 6-month follow-up. Therefore, we

were able to analyze data on 30 individuals (18 males and

12 females) through the 6-month follow-up.

At the post-intervention follow-up, a greater number of

participants in the PE group dropped out of the study than

participants in the control group (v2 (1, n = 65) = 11.38, P \ 0.001). Participants who dropped out of the study

reported lower levels of PTSS in reference to the nonHIV-

related trauma than participants who were retained at this

time point (F(1,62) = 5.49, P = 0.02). There were no

significant differences in any other demographic or study

variables between participants who dropped out and those

who were retained at any time point. Further, drop-out

rates did not differ between participants whose most dis-

tressing trauma was HIV-related compared to nonHIV-

related.

Fig. 1 Flow diagram of participant progress throughout the study

1330 AIDS Behav (2012) 16:1327–1340

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Study Groups

Prolonged Exposure

The PE intervention was conducted individually in a private

room within the social service agency by one of two clinical

psychology post-doctoral fellows who received extensive

training in conducting PE therapy. In addition to their

training, therapists received feedback throughout the dura-

tion of the intervention from experts in PE therapy to ensure

adherence to the therapeutic protocol. Each participant was

only seen by one therapist throughout the duration of the

therapy. The treatment followed standard PE protocol [65]

and consisted of 10 sessions conducted twice per week for

5 weeks. Each session lasted between 90 and 120 min.

Treatment procedures included education about common

reactions to trauma, breathing retraining, prolonged (repe-

ated) exposure to trauma memories, repeated in vivo

exposure to situations the client was avoiding due to trauma-

related fear, and discussion of thoughts and feelings related

to exposure exercises (including negative posttraumatic

cognitions). Though the structure and format of the sessions

remained the same as standard PE, the content varied, as the

therapy was individually tailored to each participant (their

most distressing trauma) and focused on HIV-related trauma

for some, and nonHIV-related trauma for others.

Weekly monitoring/wait list control group. Participants

assigned to the weekly monitoring/wait list control group

continued with their standard visits to the social service

agency, but were also contacted by their case manager once

a week for 5 weeks (the duration of the PE therapy) in

person or by telephone to ensure that they were not expe-

riencing any symptom exacerbation.

Procedure

The study protocol was approved by the human subjects

review boards of Kent State University and Summa Health

System. Potential participants were initially approached

about the study by their case manager at the social service

agency. Interested participants completed the PDS [67] to

determine eligibility for the study. Participants who likely

met criteria for PTSD then met with a Ph.D.-level clinical

psychology student who described the study in detail to

them. Interested participants provided written informed

consent. The Structured Clinical Interview with Psychotic

Screen for the DSM-IV (SCID [68]) was then administered

to ensure the presence of diagnostic levels of PTSD,

including endorsing Criterion A, associated functional

impairment, and the absence of any psychotic disorder or

other exclusionary criteria.

The baseline assessment occurred within 1 week of this

initial screening procedure. All eligible participants were

administered the PTSD Symptom Scale-Interview (PSS-I)

with regards to both HIV-related PTSD and the most

severe nonHIV-related trauma. They then completed self-

report baseline questionnaires including the Center for

Epidemiological Studies-Depression Scale (CES-D), the

Posttraumatic Cognitions Inventory (PTCI), and a self-

report scale assessing substance use over the past 30 days.

Following this baseline assessment, participants were ran-

domly assigned to the PE therapy or the weekly monitor-

ing/wait list control group. The principal investigator

(DLD) generated the allocation sequence using blocked

randomization (4:3 ratio of experimental:control partici-

pants), and the graduate student conducting the assess-

ments remained blind to group membership. Unequal

numbers of participants were assigned to each group, as it

was anticipated that the PE group would have a higher

dropout rate. PE participants completed the self-report PSS

at every other therapy session (i.e., 2, 4, 6, 8, and 10) to

track symptom progression through therapy, and reported

on substance use at the start of each therapy session.

All follow-up assessments were conducted at the social

service agency by the same blind interviewer who con-

ducted the baseline assessment. Participants completed the

same questionnaire battery that was administered at base-

line. Finally, all participants who received PE (the original

PE group and the weekly monitoring/wait listed control

group who elected to receive the intervention) also com-

pleted the same assessment 6-months post-intervention.

Participants received $25 for each assessment and $10 for

every intervention session they completed (up to $100 total

with an extra $25 if they completed all of the intervention

sessions).

Measures

Sociodemographics

Standard demographic questions about age, gender, race/

ethnicity, number of years living with HIV, sexual orien-

tation (rated on a scale of 1–9 where 1 = exclusively

homosexual/gay, 5 = bisexual, and 9 = exclusively het-

erosexual/straight), and income were administered at

baseline.

PTSD

Participants completed the 17-item Posttraumatic Stress

Diagnostic Scale [67, 69] at screening to determine whe-

ther they met likely criteria for a PTSD diagnosis. Partic-

ipants were asked to rate the frequency (0 = not at all or

only one time; 3 = five or more times a week/almost

always) with which they experienced each of the 17 PTSD

symptoms corresponding to the criteria in the DSM-IV

AIDS Behav (2012) 16:1327–1340 1331

123

within the past month. A likely diagnosis of PTSD was

considered present if the participant endorsed at least one

reexperiencing symptom, three avoidance symptoms, and

two arousal symptoms. Diagnoses were verified at

screening with the SCID with Psychotic Screen for the

DSM-IV [68]. The SCID is a gold standard structured

interview that allows interviewers to make psychiatric

diagnoses based on DSM-IV criteria.

At each assessment participants completed the PTSD

Symptom Scale-Interview (PSS-I [70]). The PSS-I is a

17-item semi-structured interview designed to measure the

frequency and severity of PTSD symptoms. The total score

is calculated based on the sum of the individual items.

Internal consistency for the PSS-I was acceptable in our

sample (HIV-related trauma baseline alpha = 0.81; Post-

intervention = 0.89; 3-month = 0.86; 6-months = .084;

NonHIV-related trauma baseline alpha = 0.81; Post-inter-

vention = 0.93; 3-month = 0.86; 6-months = 0.78).

Depression

The Center for Epidemiological Studies-Depression Scale

(CESD [71]) was administered to assess participants’ level

of self-reported depression symptoms within the week prior

to assessment at all time points. The CES-D consists of 20

items summed to create a total score. The CES-D displayed

acceptable internal consistency in our sample (baseline

alpha = 0.71; Post-intervention = 0.76; 3-months = 0.77;

6-months = 0.84).

End-state functioning. End-state functioning represents

a composite of psychological outcomes, and is typically

computed from scores on measures of PTSD, depression,

and anxiety [64, 72]; however, end-state functioning has

also been computed from PTSD and depression scores

alone [73]. Given relatively low rates of anxiety in PLWH,

composite scores for good end state functioning were

created based on reports of HIV-related PTSS, nonHIV-

related PTSS, and depression. The criteria for good end-

state functioning (yes or no) were calculated based on the

following cut-off scores: 20 or less on the HIV-related

PSS-I [59], 20 or less on the nonHIV-related PSS-I, and 16

or less on the CES-D [71].

Substance Use

A self-report substance use questionnaire was administered

at each time point to assess the frequency (measured in # of

days) of use of 11 different substances including alcohol,

marijuana, cocaine, ecstasy, amphetamines, GHB, PCP,

hallucinogens, rohypnol, ketamine, and heroin. At the

baseline, 3- and 6-month follow-up assessments, frequency

of substance use was assessed within the past 30 days.

However, given that substance use was tracked during each

PE therapy session to ensure no exacerbation of use, at the

post-intervention time point (which occurred 1 week post-

therapy), substance use was assessed over the past 7 days.

Total frequency was obtained by summing the number of

days during which substances were used.

Posttraumatic Cognitions

The self-report Posttraumatic Cognitions Inventory [23]

was used to assess negative posttraumatic thoughts. Par-

ticipants rated each of the 36 items based on how much

they agreed or disagreed with the negative thought. This

instrument yields a sum total score as well as three indi-

vidual subscale scores: negative cognitions about the self,

negative cognitions about the world, and self-blame.

Higher scores on the PTCI indicate greater endorsement of

negative posttraumatic cognitions. Internal consistency for

the present sample was high (baseline alpha = 0.94; Post-

intervention = 0.94; 3-month = 0.96; 6-month = 0.95).

Data Analysis

Preliminary Analyses

Preliminary analyses were conducted with Statistics Pack-

age for the Social Sciences Version 16 (SPSS 2006). An

alpha level of .05 (two-tailed) was used to determine sig-

nificance in all analyses. In order to test for possible control

variables, v2 analyses were applied between categorical variables (group, gender, race). One-way ANOVAs were

conducted between categorical and continuous variables to

examine group differences in age, time living with HIV, and

sexual orientation. If significant differences emerged, these

variables were used as covariates. Further, to test whether

randomization was successful, one-way ANOVAs were

conducted to determine whether the study groups differed

on any demographic or study-related variables.

Intent-to-Treat Analyses

A series of mixed-model repeated measures ANOVAs

were conducted to test whether PE was efficacious at

reducing HIV- and nonHIV-related PTSS, depressive

symptoms, negative posttraumatic cognitions, and sub-

stance use on the randomized sample from baseline to the

3-month follow-up. For these analyses, group (PE vs.

control) was the between subjects factor and time of

assessment was the within subjects factor. An intent-to-

treat (ITT) method was used in order to remove potential

bias due to participant attrition and non-compliance with

the study protocol [74]. The conservative approach of last

observation carried forward (LOCF) was applied, such that

missing values at each assessment were replaced by the last

1332 AIDS Behav (2012) 16:1327–1340

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known value reported by the participant. Therefore,

between group analyses were conducted on the 65 partic-

ipants (n = 40 for the intervention group; n = 25 for the

control group) randomized to the original study conditions.

In the presence of a significant group 9 time interaction,

post-hoc analyses were conducted in the form of one-way

ANOVAs on the change scores between each time point.

To test whether the gains of PE therapy were maintained

over the 6-month follow-up (non-randomized sample),

within subjects repeated measures ANOVAs were con-

ducted using data from the baseline, post-treatment,

3-month, and 6-month post-treatment assessments on out-

comes of interest for all participants who received the PE

therapy (including control group participants who later

received PE). The sample size for this analysis consisted of

59 participants; the participants randomized to receive PE

(n = 40) and the original weekly monitoring/wait list

control participants who opted to later receive PE (n = 19).

If a significant main effect of time emerged, pairwise

comparisons within SPSS were conducted to determine

which time points were significantly different from each

other.

Secondary Completer Analyses

A series of mixed-model repeated measures ANOVAs

were also conducted on participants who completed the

entire study protocol. Between group analyses conducted

on the randomized sample throughout 3-months consisted

of 43 participants, and within group analyses throughout

6-months consisted of 30 participants. Finally, v2 analyses were conducted to determine whether groups differed in

good end state functioning at the 3-and 6-month follow-up

assessments.

Missing Data

To include data from retained participants, missing values

were imputed for less than 1% of missing data points.

Results

Preliminary Analyses

On average, participants reported experiencing 4.91 (stan-

dard deviation (SD) = 1.78) different types of prior

trauma, and 34% of the participants reported that their most

distressing trauma was related to their HIV diagnosis.

Sixty-four of the participants reported experiencing both an

HIV-and nonHIV-related trauma, and one participant only

endorsed an HIV-related trauma. Baseline descriptive sta-

tistics for all study variables are presented in Table 1, and

descriptive statistics for the outcomes at the follow-up

assessments are displayed in Table 2. Results from v2

analyses revealed that the PE and control groups did not

differ by gender or race. Results from one-way ANOVAs

also revealed no significant differences between groups on

age, time living with HIV, sexual orientation, HIV-related

PTSS, nonHIV-related PTSS, depression, posttraumatic

cognitions, and substance use (see Table 1).

Mixed Model Repeated Measures ANOVAs: ITT

Analyses

After applying the LOCF method, mixed model (between

and within group) repeated measures ANOVAs were con-

ducted on HIV-related PTSS, nonHIV-related PTSS,

depression, negative posttraumatic cognitions, and sub-

stance use. Inferential and descriptive statistics for all

group 9 time interactions are displayed in Table 3. Results

revealed a main effect of time for both HIV-related PTSS

(Wilk’s k = 0.67; F(2, 62) = 15.65, P \ 0.001; partial g2 = 0.34) and nonHIV-related PTSS (Wilk’s k = 0.50; F(2, 61) = 31.85, P \ 0.001; partial g2 = 0.51) in that all participants demonstrated significant decreases in symp-

toms over time. This main effect was qualified by a sig-

nificant group 9 time interaction indicating that PE

participants experienced a greater decrease in HIV- and

nonHIV-related PTSS than the controls. Post-hoc analyses

revealed significant differences between baseline to post-

intervention for HIV-related PTSS (F(1,63) = 8.54,

P \ 0.01) and nonHIV-related PTSS (F(1,62) = 9.98, P \ 0.01). However, differences between baseline and 3-months were not significant.

A main effect of time was also revealed for depression

symptoms, such that they decreased throughout the course

of the study for all participants (Wilk’s k = 0.80; F(2, 62) = 7.70, P = 0.001; partial g2 = 0.20). Results also revealed a trend towards significance for a group x

time interaction, with PE participants experiencing a mar-

ginally greater decrease over time in depression symptoms.

Post-hoc analyses revealed a significant reduction in

depression symptoms from baseline to post-intervention

(F(1,63) = 4.12, P = 0.047), but differences between

baseline and 3-months were not significant.

Regarding posttraumatic cognitions, a significant main

effect of time indicated that negative posttraumatic cog-

nitions decreased throughout the study (Wilk’s k = 0.79; F(2, 62) = 8.25, P = 0.001; partial g2 = 0.21). Further, a significant group x time interaction revealed that PE par-

ticipants experienced a greater improvement in PTCI

scores than control participants. Post-hoc analyses indi-

cated significant differences from baseline to post-inter-

vention (F(1,63) = 5.93, P = 0.02), but results were not

significant through 3-months.

AIDS Behav (2012) 16:1327–1340 1333

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Results the outcome of substance use, a mixed model

repeated measures ANOVA conducted on the baseline and

the 3-month follow-up assessment revealed no main effect

of time (Wilk’s k = 0.10; F(1, 63) = 0.23, P = 0.63; partial g2 = 0.00) or group 9 time interaction.

Mixed Model Repeated Measures ANOVAs:

Completer analysis

The following analyses were performed on the 43 partici-

pants who were retained throughout all phases of the study.

Inferential and descriptive statistics for the group 9 time

interactions are displayed in Table 4. Results from mixed

model repeated measures ANOVAs replicated the ITT

findings regarding PTSS such that reductions in HIV-rela-

ted (Wilk’s k = 0.34; F(2, 40) = 38.94, P \ 0.001; partial g2 = 0.66) and nonHIV-related PTSS (Wilk’s k = 0.20; F(2, 39) = 77.99, P \ 0.001; partial g2 = 0.80) occurred for all participants throughout the course of the study.

Further, significant group 9 time interactions revealed that

PE participants experienced a greater decrease in HIV- and

nonHIV-related PTSS than control participants. Post-hoc

analyses indicated significantly larger reductions in HIV-

and nonHIV-related PTSS between baseline and post-

intervention (F(1,45) = 37.21, P \ 0.001; F(1,44) = 50.62, P \ 0.001) and between baseline and 3-month follow-up PTSS scores (F(1,41) = 16.51, P \ 0.001; F(1,40) = 19.70, P \ 0.001) in PE participants versus controls, respectively.

Results also revealed that depression symptoms were

reduced throughout the duration of the study (Wilk’s

k = 0.69; F(2, 40) = 8.85, P = 0.001; partial g2 = 0.31), and this main effect was qualified by a significant group 9 -

time interaction revealing that PE participants demonstrated

greater improvements in depression symptoms over time as

compared to control participants. Post-hoc analyses indicated

larger decreases in depression for PE participants than for

control participants from baseline to post-intervention

Table 1 Means and standard deviations from the full sample for continuous level demographic variables

Demographics Baseline (n = 65)

Prolonged exposure

Mean (SD)

Wait-list/control

Mean (SD)

F test a

Total sample

Mean (SD)

Age 46 (5.8) 48 (7.0) 1.92 46.37 (6.30)

Sexual orientation b

5.12 (3.5) 5.76 (3.5) 0.51 5.37 (3.49)

Months living with HIV 157 (68) 163 (55) 0.70 159 (63)

HIV-related PTSS 25.30 (10.26) 26.00 (9.62) 0.08 25.57 (9.95)

NonHIV-related PTSS c

27.45 (9.52) 30.42 (10.28) 1.37 28.56 (9.84)

Depressive symptoms 25.72 (10.96) 26.00 (10.58) 0.01 25.83 (10.73)

Negative posttraumatic cognitions 115.66 (37.38) 111.32 (41.09) 0.19 113.99 (38.59)

Substance use 6.72 (11.49) 6.76 (10.70) 0.00 6.74 (11.11)

SD standard deviation, PTSS posttraumatic stress symptoms

* P \ 0.05, ** P \ 0.01, *** P \ 0.001 a

F test F value from analyses examining group differences in demographic variables b

Sexual orientation. The mean score here reflects sexual orientation on a continuum from 1–9 (1 completely homosexual; 5 = bisexual;

9 = completely heterosexual) c

Sample size for analyses regarding nonHIV-related PTSS is 64 (one participant failed to report a nonHIV-related trauma)

Table 2 Means and standard deviations from the completer sample for all study outcomes

Demographics Post-intervention (n = 47) 3-month Follow-up (n = 43)

PE (n = 23) Mean (SD)

Control (n = 24) Mean (SD)

PE (n = 19) Mean (SD)

Control (n = 24) Mean (SD)

HIV-related PTSS 8.30 (4.83) 24.13 (10.66) 7.32 (6.74) 20.46 (8.94)

NonHIV-related PTSS a

7.30 (3.98) 28.09 (11.13) 6.11 (5.48) 21.26 (7.80)

Depressive symptoms 16.00 (9.46) 27.50 (11.68) 13.53 (9.99) 22.08 (12.55)

Negative posttraumatic cognitions 83.70 (30. 75) 115.08 (33.00) 78.26 (27.83) 100.71 (46.76)

Substance use – – 4.53 (12.46) 7.21 (11.07)

SD standard deviation, PTSS posttraumatic stress symptoms a

overall sample size for analyses regarding nonHIV-related PTSS is 63 (one control participant failed to report a nonHIV-related trauma

1334 AIDS Behav (2012) 16:1327–1340

123

(F(1,45) = 7.05, P = 0.011). However, the change from

baseline to the 3-month follow-up assessment was only mar-

ginally significant (F(1,42) = 3.11, P = 0.087).

Also similar to the ITT findings, results revealed a main

effect for PTCI scores to improve over time (Wilk’s

k = 0.61; F(2, 40) = 12.83, P \ 0.001; partial g2 = 0.39),

and this main effect was qualified by a significant group x

time interaction. Post-hoc analyses indicated greater

reductions in PTCI for PE participants between baseline

and post-intervention (F(1,45) = 12.16, P = 0.002) and

baseline and 3-month follow-up (F(1,42) = 16.51,

P = 0.02).

Table 3 Group 9 time interactions: intent-to-treat mixed model repeated measures ANOVAs

Outcomes Baseline

Mean (SD)

Post-intervention

Mean (SD)

3-month follow-up

Mean (SD)

Wilk’s k F Partial g2

HIV-related PTSS (n = 65) 0.86 4.86*** 0.14

PE 25.30 (10.26) 14.90 (11.09) 14.43 (11.76)

Control 26.00 (9.62) 23.28 (11.26) 19.76 (9.43)

NonHIV-related PTSS (n = 64) 0.76 9.55*** 0.24

PE 27.45 (9.52) 14.60 (11.28) 13.98 (11.96)

Control 30.42 (10.29) 26.96 (12.21) 20.42 (8.83)

Depressive symptoms (n = 65) 0.92 2.82 ?

0.09

PE 25.72 (10.96) 19.79 (10.46) 18.56 (10.96)

Control 26.55 (10.57) 26.60 (12.29) 21.40 (12.75)

Posttraumatic cognitions (n = 65) 0.90 3.28* 0.10

PE 115.66 (37.38) 97.25 (36.36) 94.28 (35.46)

Control 111.32 (41.09) 112.56 (34.68) 98.76 (46.80)

Substance use (n = 65) 0.99 0.12 0.00

PE 6.73 (11.49) – 7.75 (14.05)

Control 6.76 (10.70) – 6.92 (10.93)

SD standard deviation, PTSS posttraumatic stress symptoms, PE prolonged exposure group

Control = Wait-list/control group

* P \ 0.05, ** P \ 0.01, *** P \ 0.001

Table 4 Group 9 time interaction results from mixed model repeated measures ANOVAs: completer sample

Outcomes Baseline

Mean (SD)

Post-intervention

Mean (SD)

3-month follow-up

Mean (SD)

Wilk’s k F Partial g2

HIV-related PTSS (n = 43) 16.35*** 0.43

PE 26.42 (9.76) 8.32 (5.15) 7.32 (6.74)

Control 26.96 (8.52) 24.13 (10.66) 20.46 (8.94)

NonHIV-related PTSS (n = 42) 0.45 23.99*** 0.55

PE 28.79 (8.87) 7.42 (4.11) 6.11 (5.48)

Control 31.70 (8.34) 28.08 (11.13) 21.26 (7.80)

Depressive symptoms (n = 43) 0.85 3.44* 0.15

PE 26.47 (11.38) 16.05 (10.07) 13.53 (9.99)

Control 26.87 (9.84) 27.50 (11.68) 22.08 (12.55)

Posttraumatic cognitions (n = 43) 0.77 5.84** 0.23

PE 117.00 (36.97) 84.53 (33.27) 78.26 (27.83)

Control 113.79 (40.03) 115.08 (33.00) 100.71 (46.76)

Substance use (n = 43) 0.10 0.08 0.00

PE 3.37 (7.11) – 4.53 (12.46)

Control 7.04 (10.83) – 7.21 (11.07)

(SD) standard deviation, PTSS posttraumatic stress symptoms, PE prolonged exposure group

Control = Wait-list/control group

* P \ 0.05, ** P \ 0.01, *** P \ 0.001

AIDS Behav (2012) 16:1327–1340 1335

123

With regards to substance use, no exacerbation of sub-

stance use occurred during the PE sessions, and a one-way

ANOVA conducted between groups on the post-interven-

tion assessment supported the results from therapy ses-

sions, in that no between group differences on substance

use within the past week were present (F(1,42) = 0.09,

P = 0.77). The PE group reported an average of 2.58

(6.65) and the control group reported an average of 2.12

(3.15) instances of substance within the past seven days. A

mixed model repeated measures ANOVA conducted on

baseline and the 3-month follow-up assessment confirmed

the ITT findings and revealed no main effect of time

(Wilk’s k = 0.10; F(1, 41) = 0.14, P = 0.71; partial g2 = 0.00) or group x time interaction.

Within Subjects ITT Analyses—Through

the 6-month Follow-up

After applying the LOCF method, within subjects repeated

measures ANOVAs were conducted on 59 participants to

determine whether treatment gains persisted at the 6-month

follow-up. Time of assessment (baseline, post-intervention,

3-and 6-months post-treatment) was the within subjects

factor. Descriptive and interferential statistics are displayed

in Table 5. Results revealed significant main effects of

time for the outcomes of HIV-related PTSS, nonHIV-

related PTSS, depression and negative posttraumatic cog-

nitions, such that PE participants experienced a reduction

in symptoms over the course of the study. Post-hoc anal-

yses revealed significant mean differences between base-

line, post-intervention, 3- and 6-month assessments (see

Table 7), implying that the effects of the intervention were

maintained through 6 months after the completion of

therapy. No significant main effects of time emerged for

substance use.

Within subjects Completer Analyses—Through

the 6-month Follow-up

Results from within subjects repeated measures ANOVAs

conducted on 30 participants replicated the ITT findings (see

Table 6), in that PE participants experienced significant

reductions in HIV-related and nonHIV-related PTSS,

depressive symptoms, and negative posttraumatic cognitions

Table 5 Results for intent-to-treat within subjects repeated measures ANOVA: main effects of time

Outcomes Baseline

Mean (SD)

Post-

intervention

Mean (SD)

3-month

follow-up

Mean (SD)

6-month

follow-up

Mean (SD)

Wilk’s

k F Partial

g2

HIV-related PTSS (n = 59) 24.21 (9.78) a,b,c

13.25 (10.19) a

13.51 (10.78) b

13.07 (11.16) c

0.46 21.95*** 0.54

NonHIV-related PTSSS (n = 58) 24.93 (9.74) a,b,c

13.50 (10.43) a

13.67 (11.11) b

13.20 (10.91) c

0.49 18.76*** 0.51

Depressive symptoms (n = 59) 24.24 (10.67) a,b,c

18.88 (11.10) a

18.64 (11.32) b

19.91 (11.89) c

0.76 5.80** 0.24

Negative posttraumatic cognitions

(n = 59) 112.78 (41.84)

a,b,c 95.85 (43.22)

a 93.95 (40.03)

b 93.14 (43.43)

c 0.70 7.90*** 0.30

Substance use (n = 59) 7.66 (11.80)a,b,c – 7.00 (12.86)b 7.14 (11.01)c 0.99 0.19 0.07

SD standard deviation, PTSS posttraumatic stress symptoms

* P \ 0.05, ** P \ 0.01, *** P \ 0.001 a,b,c

Mean (SD) = Means that share superscripts are significantly different from each other

Table 6 Results for within subjects repeated measures ANOVA completer sample: main effects of time (n = 30)

Outcomes Baseline

Mean (SD)

Post-

intervention

Mean (SD)

3-month follow-

up

Mean (SD)

6-month follow-

up

Mean (SD)

Wilk’s

k F Partial

g2

HIV-related PTSS 24.27 (8.87) a,b,c

8.43 (5.64) a

9.57 (7.54) b

8.80 (8.13) c

0.19 39.65*** 0.82

NonHIV-related PTSS

(n = 29) 25.62 (9.11)

a,b,c 7.76 (5.07)

a 8.62 (7.86)

b 7.79 (6.57)

c 0.16 44.41*** 0.84

Depressive symptoms 23.87 (11.31) a,b,c

16.47 (10.58) a

15.67 (11.68) b

18.02 (13.20) c

0.62 5.47** 0.38

Negative posttraumatic

cognitions

107.84 (42.61) a,b,c

83.04 (40.46) a

81.72 (35.38) b

79.96 (41.53) c

0.54 7.75** 0.47

Substance use 5.07 (9.79) a,b,c

– 4.10 (10.55) b

5.80 (11.15) c

0.94 0.89 0.06

SD standard deviation, PTSS posttraumatic stress symptoms

* P \ 0.05, ** P \ 0.01, *** P \ 0.001 a,b,c

Mean (SD) = Means that share superscripts are significantly different from each other

1336 AIDS Behav (2012) 16:1327–1340

123

throughout 6-months post-treatment. Post-hoc pairwise

comparisons again revealed significant differences between

baseline and all follow-up assessments (see Table 7). No

significant main effects of time emerged for substance use.

End-State Functioning

Results from v2 analyses revealed that 10 PE participants (52.6%) compared to two control participants (8.3%)

met criteria for good end state functioning (v2 (1, n = 47) = 10.43, P = 0.002) post-intervention. Three-

months post-treatment, 12 PE participants (63.2%) com-

pared to six control participants (25%) met criteria for good

end-state functioning (v2 (1, n = 43) = 6.34, P = 0.01). Examination of the larger sample size due to providing PE

to the control group revealed that 18 (58%), 19 (63%), and

15 (50%) met good end-state functioning at the post-

intervention, 3- and 6-month follow-up assessments.

Discussion

To our knowledge, the current study was the first randomized

controlled trial to test the efficacy of PE therapy for PTSD in

PLWH. Consistent with hypotheses, results supported the

use of PE in this population; PE recipients demonstrated

significant improvement in both HIV- and nonHIV-related

PTSS and achieved good end-state functioning at higher

rates than a weekly monitoring/wait list control group. PE

was also successful at reducing negative posttraumatic

cognitions and depressive symptoms, although this latter

result was primarily supported in completer analyses as ITT

analyses were at the trend level. Gains achieved in therapy

for the outcomes of HIV- and nonHIV-related PTSS,

and negative posttraumatic cognitions were maintained

throughout 3-months in the completer analysis, but this

pattern of results did not emerge for the ITT analyses.

However, given that LOCF is a conservative approach to ITT

analysis, failure to find significance with this analysis may

simply reflect limited power due to a small sample size.

Further, results from within subjects analyses suggest that

the gains achieved from PE therapy were maintained

throughout 6-months for PTSS, depression, and negative

posttraumatic cognitions.

Though all group 9 time interaction effect sizes findings

were large (partial g2 C 0.14), the intervention accounted for the largest proportion of variance in HIV- and nonHIV-

related PTSS. Additionally, the magnitude of change for

both types of PTSS in the completer analyses was robust—

the decline in HIV-related PTSS for PE participants was

19.58 points compared to a reduction of 6.47 for control

participants. The change in nonHIV-related PTSS was

equally large—a 22.68 point reduction for PE participants

compared to a 9.96 point reduction for control participants.

It is important to keep in mind that although the largest

reduction in PTSS occurred for the PE participants in

regards to their HIV-related trauma, the PE therapy itself

was aimed at treating participants’ most distressing trauma.

As mentioned before, only 34% of participants regarded

their HIV-related trauma as being the most traumatic and

thus targeted it in therapy, implying that the remaining

66% of participants targeted a nonHIV-related trauma in

PE therapy. Given the observed significant reductions in

both HIV- and nonHIV-related PTSS, results suggest that

participants may have learned skills allowing them to

transfer the gains of therapy to other traumas. PE partici-

pants also experienced significant reductions in depressive

symptoms that were maintained throughout 3-months for

the completers, and reductions in negative posttraumatic

cognitions which were maintained throughout 6-months in

both sets of analyses, supporting the efficacy of PE at

decreasing a range of posttraumatic sequalae. Consistent

Table 7 Post-hoc pairwise comparisons for within subjects analyses

Outcomes t t t Baseline to post-

intervention

Baseline to 3 month follow-

up

Baseline to 6-month follow-

up

HIV-related PTSS: ITT 8.04*** 6.80*** 7.20***

NonHIV-related PTSS: ITT 7.58*** 6.82*** 7.07***

Depressive symptoms: ITT 3.84*** 3.54** 3.41**

Negative posttraumatic cognitions: ITT 4.67*** 4.38*** 4.73***

HIV-related PTSS: completer sample 10.55*** 7.01*** 7.80***

NonHIV-related PTSS: completer sample 11.46*** 8.13*** 9.00***

Depressive symptoms: completer analysis 3.88** 3.00** 2.73*

Negative posttraumatic cognitions: completer

analysis

4.75*** 3.88** 4.35***

PTSS posttraumatic stress symptoms, ITT intent-to-treat analyses

* P \ 0.05, ** P \ 0.01, *** P \ 0.001

AIDS Behav (2012) 16:1327–1340 1337

123

with prior research [75, 76], substance use did not worsen

over the course of treatment which lends support to the

continued use of PE in PLWH who may have comorbid

substance use issues.

Although the dropout rate (32%) for PE participants in

the current study was within the range of dropout rates

reported in exposure therapies for treating PTSD in non-

medical populations (20.5–34% [77–79]; for recent

reviews, see [80, 81]), differential drop-out rate was an

issue for the present sample. A greater proportion of PE

recipients versus controls dropped out by post-intervention.

Given that differential drop-out can bias the outcome

estimates and their corresponding significance, the present

results warrant replication and should be viewed with

caution until further investigations confirm these findings.

Despite this differential dropout, only five participants

withdrew from the therapy because they either lost interest

in continuing PE or thought the therapy was too much to

handle at the current time. Additionally, as the present

results were significant using conservative LOCF method

in the ITT analyses, this suggests that differential dropout

did not bias the present findings.

The high rates of post-traumatic distress observed in

PLWH combined with the success of the present pilot

study would underscore the importance of screening for

PTSS and depression symptoms in routine visits to health

care professionals [57, 82–84]. Further, as prior research

has suggested that addressing PTSD and mental health

comorbidities may be a necessary step in the process of

improving adherence in PLWH [30, 85, 86], perhaps PE

could provide an efficient means by which to decrease

post-traumatic distress and comorbid disorders and possi-

bly increase the efficacy of subsequent adherence and

substance use interventions.

Strengths of the present study include the heterogeneity

of the sample (males, females, varying sexual orientations,

varying amounts of time living with HIV), as the exclu-

sionary criteria were limited which allowed for the imple-

mentation of a practical intervention in a ‘‘real-life’’ setting.

Several prior studies in PLWH have been conducted in

limited samples of only women [4, 11, 31], or homosexual/

bisexual men [3, 87]. Further, the inclusion of PLWH with

various comorbidities allowed for high external validity, as

it is rare for PTSD to exist as an independent psychological

disorder. PTSS were also assessed via interview rather than

self-reported questionnaire.

Though the present results provide preliminary evidence

for the efficacy of PE in PLWH, they should be viewed

with caution in the presence of some limitations. The small

sample size of the present study limits power in conducting

mediation or moderation analyses, and the lack of a control

group at the 6-month assessment excludes the possibility

for comparison of the long-term effects of therapy. Despite

these limitations, results from this study provide support

for the utility of PE therapy as an efficacious intervention

for PLWH. The therapy was readily accepted by PLWH,

with a drop-out rate comparable to other studies utilizing

exposure therapy. The results expand and improve upon

previous mental health interventions that have been offered

to PLWH by specifically targeting PTSD with an evidence-

based, first-line intervention for the disorder.

Acknowledgments Funding for this study was provided by the National Institute of Mental Health (R34 MH 71201).

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  • c.10461_2011_Article_76.pdf
    • The Impact of Prolonged Exposure on PTSD Symptoms and Associated Psychopathology in People Living with HIV: A Randomized Test of Concept
      • Abstract
      • Resumen
      • Introduction
        • Prolonged Exposure Therapy
      • Method
        • Participants
        • Study Groups
          • Prolonged Exposure
        • Procedure
        • Measures
          • Sociodemographics
          • PTSD
          • Depression
          • Substance Use
          • Posttraumatic Cognitions
        • Data Analysis
          • Preliminary Analyses
          • Intent-to-Treat Analyses
          • Secondary Completer Analyses
          • Missing Data
      • Results
        • Preliminary Analyses
        • Mixed Model Repeated Measures ANOVAs: ITT Analyses
        • Mixed Model Repeated Measures ANOVAs: Completer analysis
        • Within Subjects ITT Analyses---Through the 6-month Follow-up
        • Within subjects Completer Analyses---Through the 6-month Follow-up
        • End-State Functioning
      • Discussion
      • Acknowledgments
      • References