Peer review summary

BRIEF REPORT

Uncontrolled Pilot Study of an Acceptance and Commitment Therapy and Health at Every Size Intervention for Obese, Depressed Women:

Accept Yourself!

Margit I. Berman, Stephanie N. Morton, and Mark T. Hegel Geisel School of Medicine at Dartmouth

Depression and obesity frequently co-occur, but providing adequate treatment to depressed obese women is challenging because existing treatments for each problem in isolation are suboptimal, and treatments to address one problem may exacerbate the other. This study used an uncontrolled, pretreatment-to- posttreatment design, with 3-month follow-up, to evaluate the feasibility and outcome of a novel, self-acceptance-based treatment for obese women with depression, “Accept Yourself!” Accept Yourself! is an 11-week manualized, group-based intervention that integrates Health At Every Size (an evidence- based paradigm to enhance physical health) and Acceptance and Commitment Therapy (an evidence- based psychotherapy often used to treat depression and eating-related concerns) to improve the physical and mental health of obese, depressed women without encouraging weight loss. Twenty-one obese women with Major Depressive Disorder received the intervention; 18 completed at least seven sessions, a minimal dose of the intervention. Depressive symptoms, depression diagnosis, physical health out- comes (including physical activity and blood pressure), and obesity-related quality of life were assessed at baseline, posttreatment, and 3-month follow-up. Weight was also monitored. Depression, blood pressure, and obesity-related quality of life significantly improved from pretreatment to posttreatment, and improvements were sustained over a 3-month follow-up. Participants did not gain significant weight during the intervention or at follow-up. These data, although preliminary and nonexperimental, suggest that Accept Yourself! could be a promising treatment for obese, depressed women, and support the value of larger randomized controlled trials.

Keywords: Accept Yourself!, acceptance and commitment therapy, health at every size, depression, obesity

Although depression and obesity in women are both common (Kessler et al., 2005; Ogden, Carroll, Kit, & Flegal, 2012) and commonly co-occur (Pagoto et al., 2007; Simon et al., 2008), treating both conditions at once presents serious challenges. Even among nondepressed individuals, behavioral weight loss efforts

and interventions have generally poor long-term outcomes (Franz et al., 2007; Mann et al., 2007; Neumark-Sztainer, Wall, Story, & Standish, 2012). However, weight-loss interventions are even less effective among depressed individuals (Clark, Niaura, King, & Pera, 1996; McGuire, Wing, Klem, Lang, & Hill, 1999; Roberts, Deleger, Strawbridge, & Kaplan, 2003). In addition, in women, depression and obesity interact reciprocally over time: Depression predicts onset of obesity, and obesity predicts later depression (Faith et al., 2011; Luppino et al., 2010; Roberts et al., 2003). Poor health, functional impairment, obesity stigma, and body image dissatisfaction may all contribute to depression, while depression’s biological and psychosocial effects may lead to weight gain (Markowitz, Friedman, & Arent, 2008). Prescribing dieting for depressed women presents important risks, as dieting can also cause or worsen depression, via cognitive, behavioral, and biolog- ical pathways (Markowitz et al., 2008).

Only two randomized controlled trials have investigated behav- ioral treatments for women with both obesity and depression. Outcomes for both were modest, and neither addressed the bidi- rectional relations between obesity and depression, nor amelio- rated the risks of dieting. In the Be Active trial (Pagoto et al., 2013), behavioral activation plus a diet and exercise intervention

This article was published Online First October 31, 2016. Margit I. Berman, Stephanie N. Morton, and Mark T. Hegel, Department

of Psychiatry, Geisel School of Medicine at Dartmouth. This research was supported by a grant to the first author from the

Geisel School of Medicine at Dartmouth Department of Psychiatry. This research was also supported by a Health Promotion and Disease Prevention Research Center supported by Cooperative Agreement Number U48DP005018 from the Centers for Disease Control and Prevention. The findings and conclusions in this article are those of the author(s) and do not necessarily represent the official position of the Centers for Disease Control and Prevention. We thank Meagan Dechen for her assistance with this research.

Correspondence concerning this article should be addressed to Margit I. Berman, 5D – Psychiatry, Dartmouth-Hitchcock Medical Center, 1 Med- ical Center Drive, Lebanon, NH 03756. E-mail: Margit.I.Berman@ dartmouth.edu

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Psychotherapy © 2016 American Psychological Association 2016, Vol. 53, No. 4, 462–467 0033-3204/16/$12.00 http://dx.doi.org/10.1037/pst0000083

462

based on the Diabetes Prevention Program (DPP) was compared with DPP alone. Participants in both conditions had lost an average of only 3% body weight at 1 year, an amount too small to offer health benefits, and much more modest than clients or clinicians desire (Foster, Wadden, Vogt, & Brewer, 1997). Combined treat- ment did enhance participant mood slightly more than weight loss alone for some measures. Similar very modest weight loss (�3%) and mood improvements, with no difference between treatments, were also found in a second randomized controlled trial that compared behavioral weight loss plus cognitive–behavioral ther- apy to weight loss alone (Linde et al., 2011). These interventions also had little effect on physical health outcomes other than weight loss.

New interventions are needed that address the bidirectional relationship between obesity and depression, and offer alternatives to dieting. Self-acceptance-based treatments are one option. The Health at Every Size® (HAES) paradigm is used to enhance the physical health of obese people without weight loss. HAES par- ticipant improvements in physical health (e.g., metabolic and car- diovascular fitness) and health behaviors (e.g., physical exercise) appear to be longer-lasting than weight-loss programs, and partic- ipants are more adherent to HAES (Bacon & Aphramor, 2011), but HAES does not address depression. Similarly, Acceptance and Commitment Therapy (ACT) is a psychotherapy that focuses on acceptance (rather than control) of emotions, as well as promoting valued life behaviors. ACT has shown efficacy for depression (Markanday et al., 2012) and eating-related concerns (Berman, Boutelle, & Crow, 2009; Lillis, Hayes, Bunting, & Masuda, 2009). However, no research has integrated these two approaches.

We have developed a manualized group-based program, Accept Yourself! (Berman, Morton, & Hegel, in press), that integrates ACT and HAES to enhance the physical and mental health of obese women with Major Depressive Disorder (MDD), without encouraging weight loss. Our goal is to provide initial data about the safety and feasibility of the approach in an uncontrolled pre- to posttreatment design with 3-month follow-up. We hypothesized that (a) After Accept Yourself!, participants would show signifi- cant improvements in depressive symptoms (primary outcome), physical activity, blood pressure, obesity-related quality of life, and obesity-related stigma (secondary outcomes), which would be maintained at 3-month follow-up. We also hypothesized that (b) women would show low (�20%) attrition from the program. Finally, we hypothesized that (c) participants’ trajectory of change over time in depression and physical activity would reflect greater improvement during treatment than while women waited for treat- ment to begin.

Methods

This research project was approved by Dartmouth College’s Committee for the Protection of Human Subjects, and informed consent was obtained from all participants.

Participants

Figure 1 illustrates the flow of participants through the study. Participants were recruited from November 2013 to September 2014 via community advertisements and physician referral. Two consecutive groups (Spring & Fall, 2014) participated in Accept

Yourself! We included adult women with MDD and a body mass index (BMI) � 30, who were at least mildly depressed. We excluded women with: current substance abuse/dependence, a history of psychosis, high risk of suicide/self-harm, unwillingness to try a nondieting approach, current weight-loss efforts or psy- chotherapy, weight loss surgery in the past year, inability to postpone weight or depression interventions, medication changes �6 weeks before baseline or during the study, or usage of antipsychotic, tricyclic, or corticosteroid medications.

Twenty-one women in two groups (Group 1: n � 11; Group 2: n � 10) completed Accept Yourself! Sample size was determined by the number recruited during the study time frame. Participants’ mean age was 49 (range 23–66), and mean BMI was 37 (range 31–50). Most (67%) were married/partnered; 67% worked full time; 91% were White. All had at least some college education; 43% had education beyond a bachelor’s degree. Most (86%) reported income �$40,000 per year. The median number of pre- vious depressive episodes reported was 10, and 45% were taking antidepressants. Groups did not differ significantly on these base- line variables, or on initial depression (Hamilton Depression Rat- ing Scale, HAMD, Hamilton, 1960) score at prescreen or baseline.

Procedure and Intervention

Accept Yourself! has been described in detail elsewhere (Ber- man et al., in press). Briefly, the intervention consists of eleven 2-hr meetings. A variety of interventions teach ACT and HAES concepts, including mindfulness and movement (e.g., dance, yoga), psychoeducation, discussions, and experiential exercises. Homework is assigned and reviewed at each session. Group 2 participants also received a workbook (available on request) to reinforce the material.

Measures were administered (and a $50 incentive provided) at three main assessments: baseline, posttreatment, and 3 months after the last group. The HAMD was also assessed during a telephone prescreen. Participants also completed weekly measures (see below) of depression and physical activity while they waited for the group to begin (pretreatment phase) and at each Accept Yourself! session (treatment phase). Participants were also asked for demographic data and about exclusion criteria. The interven- tion and all clinician-rated measures were administered by the first author, a licensed psychologist experienced using these measures in research.

Measures

Structured Clinical Interview for DSM–IV Research Version. The Structured Clinical Interview for DSM–IV Re- search Version (First, Spitzer, Gibbon, & Williams, 2002) is considered the “gold standard” for diagnostic interviewing and establishing psychiatric diagnosis (Steiner, Tebes, Sledge, & Walker, 1995). The Screening, Mood, Psychotic, and Substance Use Disorders modules were administered at baseline to establish eligibility. The Mood module was administered at posttest and follow-up to assess remission.

Patient Health Questionnaire—9 item Depression Scale. The Patient Health Questionnaire—9 item Depression Scale (PHQ-9; Kroenke, Spitzer, & Williams, 2001) is the nine-item self-report depression screening module of the Patient Health

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463ACCEPT YOURSELF!

Questionnaire. Scores range from 0 to 27; (0–4 � none; 5–9 � mild; 10–14 � moderate; 15–19 � moderate-severe; � 20 � severe depression). The PHQ-9 has demonstrated good psycho- metric properties (Kroenke et al., 2001). Cronbach’s alphas in this sample ranged from .81 to .93.

Hamilton Rating Scale for Depression–17 Item. The Ham- ilton Rating Scale for Depression–17 Item (HAMD, Hamilton, 1960, administered using the Structured Interview Guide for the HAMD, Williams, 1988) is a clinician-rated measure of depression

severity. A score �10 (mild depression) at prescreen was required for inclusion. The HAMD has demonstrated validity, interrater and test–retest reliability, but often has poor internal consistency, es- pecially in depressed and middle-aged samples (Bagby, Ryder, Schuller, & Marshall, 2004; Trajković et al., 2011). Cronbach’s alpha therefore may not reflect HAMD reliability; alphas in this sample ranged from .45 to .73.

Physical activity. The Stanford Seven-Day Physical Activity Recall (PAR; Sarkin et al., 1997) is an eight-item interviewer-

Assessed for eligibility (n = 171)

Not included (n = 6) • Unable to reach after pre-screening (n =1) • Refused to participate (n = 5) Excluded (n = 144) • BMI < 30 (n = 29) • Current substance abuse or psychotic

symptoms (n = 3) • No MDD or depressive symptoms (n =

36) • High risk of suicide (n = 4; all counseled

to contact their PCP or mental health professional)

• Currently in counseling (n = 21) • Currently in a weight loss program or

unwilling to try a non-dieting approach (n = 12)

• Recent medication changes or unstable medications (n = 18)

• Taking antipsychotic, steroid, or tricyclic antidepressant medications (n = 21)

Entered Trial (n = 21)

Group 2: Completers (n = 10) • Attended 9 sessions (n = 1) • Attended 10 sessions (n = 4) • Attended all sessions (n = 5) Everyone completed group 2.

noi tn evret nI

tne mllo rnE

Group 1: Completers (n = 8) • Attended 7 sessions (n = 1) • Attended 9 sessions (n = 2) • Attended 10 sessions (n = 3) • Attended all sessions (n = 2) Group 1: Non-completers (n = 3) • Attended 3 sessions (n = 1) • Attended 4 sessions (n = 2)

pu wolloF

Group 2: Post-group and three- month follow-up assessments completed (n = 10).

Group 1: Post-group assessments completed (n = 10). • 1 non-completer also did not

complete post-group assessment. Three-month follow up assessments completed (n = 11).

Total Referred or Self- Referred (n = 204)

Refused to participate (n = 23) Refusal reasons: • Time constraints (n = 15) • Lives too far away (n = 3) • Not interested (n = 2) • Privacy concerns (n = 1) • Received treatment elsewhere (n = 1) • Too much stress (n = 1) Not included (n = 10) • Unable to reach after initial contact (n

=10)

Figure 1. Accept Yourself! participant flow through the study.

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464 BERMAN, MORTON, AND HEGEL

administered measure of self-reported physical activity. The PAR has demonstrated good psychometric properties across several studies (Sarkin et al., 1997).

The Obesity-Related Well-Being Questionnaire. The Obesity-Related Well-Being Questionnaire (ORWELL-97; Man- nucci et al., 1999) is an 18-item, 4-point Likert-type self-report measure of obesity-related quality of life. The ORWELL-97 has demonstrated adequate reliability and validity in previous research (Mannucci et al., 1999). Cronbach’s alphas in this sample ranged from .71 to .86.

The Weight Self-Stigma Questionnaire. Weight-related self-stigma was assessed using the 12-item, 5-point Likert-type Weight Self-Stigma Questionnaire (Lillis, Luoma, Levin & Hayes, 2010), the only available validated measure of this construct. Alphas in this sample ranged from .80 to .85.

The Body Image Acceptance and Action Questionnaire. The Body Image Acceptance and Action Questionnaire (BIAAQ; Sandoz, Wilson, Merwin, & Kellum, 2013) is an ACT measure of body-image flexibility used in ACT eating disorder research. It is a 12-item, 7-point Likert-type scale, with good psychometric prop- erties (Sandoz et al., 2013). Alphas in this sample ranged from .92 to .95.

Vital signs. A Life Source UA-851 sphygmomanometer as- sessed blood pressure, with results equivalent to those obtained using cuff/stethoscope auscultation, within American National Standards Institute limits for electronic sphygmomanometers (A&D Medical, 2009). BMI was computed with a wall-mounted stadiometer and electronic scale.

Weekly measures. Each week between baseline and the first group, and at each group session, participants completed the PHQ-9 and the Physical Activity Assessment (PAA). The PAA was a three-item, study-designed measure of light, moderate, and high-intensity physical activity, adapted from the National Heart, Lung, and Blood Institute’s (2015) Guide to Physical Activity, with items such as, “In the last 24 hours, how many minutes did you engage in moderate-intensity physical activity (e.g., faster walking, weeding the garden, cycling, tennis)?”

Data Analysis

Repeated measures ANOVA was used to Test Hypothesis 1. Descriptive statistics determined attrition level (Hypothesis 2).

Individual participants were the unit of analysis for all analyses, which were conducted with IBM SPSS statistics (version 22). Simulation Modeling Analyses (SMA) were conducted with SMA software and were used to Test Hypothesis 3. SMA are a variant of bootstrapping methodologies used to detect effects of treatment phase (e.g., pretreatment vs. treatment) on outcome, correcting for autocorrelation, in small time series. SMA can also detect differ- ences in the slope of change between phases. It is more appropriate than hierarchical linear models or autoregression when the number of datapoints per phase is �30, and is often used in single case psychotherapy outcome research (Borckardt et al., 2008). Pear- son’s r (parametric correlation between the outcome and phase or slope vector) is the recommended statistical test for SMA (Borck- ardt et al., 2008). At least five assessments per phase are required for SMA. We excluded four participants because they had less than five pretreatment assessments.

Results

As shown in Table 1, which displays the results of repeated- measures ANOVA tests for depression, physical health, and obesity-related well-being, Hypothesis 1 was largely supported. Both clinician-rated (HAMD) and self-reported (PHQ-9) depres- sion scores dropped from moderate or moderately severe at pre- screening and baseline to mild or normal range following treat- ment, and remained improved at follow-up. Depression diagnoses also improved. All completers met criteria for current MDD at baseline; two (11%) also met criteria for Dysthymic Disorder. Most (83%) had remitted from MDD by posttreatment, and none met criteria for Dysthymic Disorder. Most (67%) remained remit- ted from MDD at follow-up; one (6%) met criteria for Dysthymic Disorder at follow-up. Completers also significantly improved on obesity-related quality of life, body image acceptance, weight self-stigma, and systolic and diastolic blood pressures, and these improvements were sustained at follow-up. Although mean hours of self-reported physical activity increased between baseline and posttreatment, and again at follow-up, these differences were not significant.

Hypothesis 2 was also supported. Attrition was low: 14% (3 of 21, less than hypothesized) attended �7 sessions of Accept Your- self! We excluded noncompleters from all other analyses; how- ever, including them in the tests displayed in Table 1 did not

Table 1 Repeated Measures ANOVA Results

Variable (N � 18 unless noted)

Pre-screen (0) Baseline (1)

Post- treatment (2) Follow-up (3)

Bonferroni- corrected post hoc

comparisonsM SD M SD M SD M SD F(dftime, dferror) p �p 2

Self-reported depression 15.5 4.66 7.97 7.1 6.44 6.67 F(2, 34) � 18.52 �.001 .52 1 � 2, 3 Clinician-rated depressiona 17.5 4.13 18.11 4.47 6.11 5.44 7.11 4.8 F(2.2, 37.1) � 47.6 �.001 .74 0, 1 � 2, 3 Systolic blood pressure 135.56 18.7 125.94 12.54 125.89 15.47 F(1.3, 22.2) � 4.42 .04 .21 None Diastolic blood pressure 86.67 10.84 83.89 11.45 79.61 10.02 F(2, 34) � 6.62 .004 .28 1 � 3 Obesity-related quality of life (N � 15)a 63.5 21.2 36.6 18.3 37.1 21.2 F(1.4, 19.8) � 14.87 �.001 .52 1 � 2, 3 Body image acceptance (N � 17)a 2.7 1.2 4.6 1.3 4.6 1.2 F(1.3, 21.5) � 19.59 �.001 .55 1 � 2, 3 Weight self-stigma 45 8.2 34.8 9.1 35 7.8 F(1.4, 24.3) � 17.28 �.001 .51 1 � 2, 3 Physical activity (hours per week, N � 16)a 6.58 7.97 8.38 6.54 9.67 8.02 F(1.4, 21) � 1.44 ns .09 N/A Weight (in pounds)a 226.7 35.3 231.3 35.7 230 38 F(1.4, 23.4) � 2.57 ns .13 N/A

a Greenhouse-Geisser correction for sphericity.

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465ACCEPT YOURSELF!

change the pattern of results for any outcome. No one was re- moved from the protocol for suicidality or adverse events.

Although weight loss was not a focus or goal of the Accept Yourself! intervention, we were interested in whether participants maintained their weight during and after the intervention. As shown in Table 1, there was no significant weight change over time. Mean BMI differed by �1 point across assessments.

We used SMA to detect the effects of treatment phase (pretreat- ment vs. treatment) on individual participants’ weekly measures of depression and physical activity, to test Hypothesis 3. Treatment phase was significantly correlated with physical activity for some participants. Specifically, 3 of the 14 participants included in these analyses (21%) reported spending significantly more total time on physical activity during the treatment phase than during the pre- treatment phase (Pearson’s rs ranged from .52 to .86; ps ranged from .001 to .05). Half of the participants (7 of 14) also showed evidence of a significant trajectory of greater improvement during treatment compared with the pretreatment phase (rs from �.62 to .87; ps from .001 to .05; note that different patterns of improve- ment may yield negative or positive correlations, as different slope patterns are tested). One participant showed evidence of a signif- icantly worsening trajectory of physical activity during treatment. Specifically, this participant had an initially high level of activity that decreased during pretreatment, increased again at the begin- ning of treatment, but then again decreased as treatment progressed (r � �.52, p � .05 for this analysis for this participant). The remaining six participants showed no significant patterns of in- creasing or decreasing physical activity in the treatment versus pretreatment phases.

Treatment phase was not significantly correlated with depres- sion for any participant. Approximately 36% (5 of 14) showed evidence of a significant trajectory of improvement in depression in the treatment phase versus the pretreatment phase (rs from �.95 to �.63; ps from .001 to .04). Thus, even though mean depression scores were not lower during treatment versus pretreatment, for these participants, there was evidence of level or increasing de- pressive symptoms during pretreatment, followed by improvement during treatment. Approximately 43% (6 of 14) showed no signif- icant trajectory of change in depression in treatment versus pre- treatment. Three participants (one of whom also worsened in physical activity) showed evidence of a significant trajectory of worsening in depression during treatment (rs from �.79 to .62; ps from .02 to .05).

Discussion

In this pilot study, we provide some initial evidence about the feasibility and safety of a brief, manualized ACT and HAES intervention, Accept Yourself!, for obese women with depression. The program appeared safe and feasible. Attrition was low. Par- ticipants did not gain significant weight, even though participants agreed not to engage in weight loss strategies during the study. No one was removed from the protocol for suicidality or other adverse events.

Depression, blood pressure, obesity stigma, body acceptance, and quality of life improved significantly during treatment, and these improvements were sustained over a brief follow-up, al- though given the small sample size and lack of experimental control, these outcomes must be interpreted with caution. SMA

also suggested that most participants improved during treatment (and not during a pretreatment assessment phase) either on total quantity of physical activity or at increasing physical activity over time. Improvements occurred even without weight loss.

These findings suggest that Accept Yourself! is feasible and might offer some promise to enhance the physical and mental health of obese women with depression. However, this study also has a number of limitations. This study was not experimental. With a single therapist, no control condition, and equivocal results for statistical analyses that compared pretreatment to treatment phases, we can make no causal claims about the efficacy of Accept Yourself! The number of participants was small, and analyses may therefore have been underpowered to detect effects. In addition, because the first author was the study therapist as well as the unblinded assessor, clinician-rated outcomes could be biased, al- though self-reported outcome measures yielded similar findings to clinician-rated measures. The sample was also overwhelmingly White and well-educated, and these results may not generalize to more diverse samples.

In summary, these preliminary results suggest that Accept Your- self! is feasible and safe. A randomized controlled trial is indicated to address the limitations of this study and test whether Accept Yourself! is efficacious in enhancing the health of obese, de- pressed women.

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Received January 29, 2016 Revision received June 1, 2016

Accepted June 7, 2016 �

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