Order 924380: critically appraised topic and implementation of the evidence

1

Clinical Problem

Social Anxiety is described by The Diagnostic and Statistical Manual of the American

Psychiatric Association (DSM-5) as a persistent fear of social situations where the person is

exposed to people or to possible scrutiny by others and fears that he/she will display

symptoms of anxiety or be perceived in a way that will be embarrassing and humiliating

(American Psychiatric Association, 2013). This topic was chosen as according to Kessler et

al. (2012) social anxiety is among the most common anxiety disorder affecting 13% of

individuals at some stage in their lives. From experience, and according to Krysta et al.

(2015) medication is the first line treatment for anxiety disorders due to accessibility.

Unfortunately, for people experiencing social anxiety most medications have adverse effects

such as increased agitation and sexual dysfunction (Rosen et al 1999) and some medication,

in particular benzodiazepines are highly addictive (Lader and Kyriacou, 2016). Townend et

al. (2008) report that CBT remains the psychological therapy with the widest and broadest

evidence base. Beck et al (1979) define Cognitive Behavioural Therapy (CBT) as a concept

where an individual’s emotions and behaviours are based on the way that they interpret the

world through their cognitions. NICE (2011) (cited in Clark, 2011) recommend psychological

therapies prior to medication for anxiety disorders however due to a lack of therapists in

mental health services this is not the case in clinical practice which led to the rationale for the

following research question.

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Clinical question

Are psychological interventions more efficacious than pharmacological interventions to help

reduce social anxiety disorder (SAD) symptoms in adults?

Bragge (2010) explains that answerable clinical research questions have four essential

components known as PICO. This therapy type question was developed using these

components (P) Population: adults that experience social anxiety (I) Intervention:

Psychological interventions (C) Comparator: Pharmacological Interventions (O) Outcome:

reduction of social anxiety symptoms.

Search Strategy and Outcome

A systematic literature search was carried out using electronic databases which were

individually accessed via Queens Online, including MEDLINE, Science Direct, PschINFO

and Cochrane (see Appendix 1). Roberts and Dicenso (1999) suggest that questions in

relation to interventions and their effectiveness are best answered by randomized control

trials or based on the hierarchy of evidence, systematic reviews. BestBets.org was also

accessed for evidence based synopses.

The three papers the author deemed relevant to answer the clinical question above are as

follows;

Clark et al. (2003)

Nordahl et al (2016)

Davidson et al. (2004)

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These three studies were chosen as their methodological design appeared to answer the

clinical question posed. They were critically appraised using the Critical Appraisal Skills

Programme (CASP UK, 2017) relevant tool as a foundation. Nadelson and Nadelson (2014)

teaches that the CASP tools effectively cover the areas needed to critically appraise evidence.

Initially, presumptions were made that databases would be inundated with literature on this

topic but it became apparent that limited appropriate journals were available. On reflection,

individuals with social phobia find it difficult to engage for fear of being negatively appraised

(Amir et al. 2009), and therefore would find it difficult to engage with psychiatric services

and clinical trials.

Critical appraisal

The randomized placebo-controlled trial by Clark et al. (2003) set out to compare cognitive

therapy with fluoxetine in generalized social phobia. Sixty patients aged between 18 and 60

years of age with a diagnosis of generalized social phobia as per the DSM-IV criteria were

randomly assigned to three arms; Cognitive therapy, Fluoxetine + self-exposure and placebo

+ self-exposure.

The study by Clark et al. (2003) addressed a clearly focused issue as the population studied,

the intervention given and the comparator are all presented in the main body of the article

however, the outcomes are not clearly specified. Stanley (2007) highlights that a primary

outcome will decide on the overall result of the study, adding that an RCT must have only

one primary outcome and should be clearly defined. Stratified randomisation was carried out

including two variables; gender and avoidant personality disorder and allocation concealment

followed which both decrease bias and increase validity. Stratified randomization, uses

random selection within each strata in an attempt to ensure that no bias, deliberate or

4

accidental, interferes with the representative nature of the patient sample (Altman & Bland

1999). Allocation to fluoxetine or placebo were double blinded, this is important as blinding

seeks to reduce performance and ascertainment bias after randomization (Altman & Schulz

2001). The groups appear to have been treated equally as assessments were carried out by an

independent assessor which reduces bias and therefore increases validity.

The study provides a paragraph of the patient’s characteristics and emphasises that there were

no significant differences between the arms. A table of patient characteristics and distribution

to arms would have made this clearer and limit any doubt of bias. An explanation for the

patients that dropped out was also provided, however, a CONSORT flow chart which would

show the flow of participants through each stage of the study would have made it clearer.

An intention to treat (ITT) analysis was utilised and dropouts were accounted for. ITT is a

strategy for the analysis of RCT’s that compares patients in the original groups to which they

were randomly assigned (Hollis & Campbell 1999). ITT analysis ensures true effects of a

study by accepting that noncompliance and protocol deviations are likely to occur in actual

clinical practice (Gupta, 2011). ITT analysis therefore avoids bias, as without it researchers

could selectively exclude participants from the groups they were randomized to. Clark et al.

(2003) reported that they employed a self-report measure developed by themselves which

could introduce bias and would make it difficult for other researchers to replicate this study.

Overall, the researchers of this study appear to have covered sufficient aspects to ensure

internal validity.

The randomised clinical trial by Nordahl et al. (2016) aims to evaluate whether Paroxetine

(SSRI) is more effective than Cognitive therapy and whether a combination of the treatments

is more effective than the single interventions in the treatment of Social Anxiety Disorder

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(SAD) with and without avoidant personality disorder (APD). 102 participants were

randomly allocated to four arms of the trial; Paroxetine, pill placebo, Cognitive therapy (CT),

and a combination of Paroxetine and CT.

The study by Nordahl et al. (2016) clearly addressed a focused issue as the population,

intervention, comparator and outcomes were clearly identified. The rating scales ADIS-IV,

SCID-II, both the primary outcomes and the secondary outcomes were rated and assessed by

independent evaluators increasing validity. However, it could be suggested that these

independent assessors were blinded also as Karanicolas et al. (2010) reports that bias can be

introduced both intentionally and unintentionally.

Similar to Clark et al. (2003) stratified randomization was carried out to ensure equal

distribution of gender and Avoidant Personality Disorder (APD) increasing validity.

According to Hidalgo et al. (2001) there is a higher incidence of SAD in women with

Eikenaes (2015) adding that there is an uncertainty whether APD and SAD are different

disorders, or are different degrees of severities of SAD. Triple masking of the patient,

psychiatrist and principle investigator was carried out for the arms receiving pills

(paroxetine/placebo), the goal of masking is to minimize potential biases (Forder et al. 2005)

which therefore increases validity of the trial. The study also informs us that 15% of the

patients were interviewed by telephone which could introduce bias as not all the patients were

treated the same. As psychiatrists and therapists were all experts in this study, allegiance bias

may have been introduced, allegiance bias in psychotherapy outcome studies refers to the

results being distorted by the investigators’ theoretical or treatment preferences (Wilson et al.

2011). Overall, the researchers appeared to cover sufficient aspects for the reader to accept its

validity.

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The randomized double blind placebo controlled trial by Davidson et al. (2004) compared

fluoxetine (FLU), comprehensive cognitive behavioural group therapy (CCBT) , placebo

(PBO) and the combinations of CCBT/FLU and CCBT/PBO to treat generalized social

phobia over a 14 week period. 295 participants were randomized evenly into the 5 arms,

primary outcomes were measured with the Brief Social Phobia Scale and Clinical Global

Impressions scales and the secondary outcome was a videotaped behavioural assessment

using the Subjective Units of Distress Scale (SUDS).

An evaluator independent from the team was blinded and assessed both the primary outcomes

reducing bias and increasing validity. The study was carried out at two academic outpatient

psychiatric centres in Durham and Pennsylvania covering large populations.

Block randomization was carried out by a computer program which reduces bias however the

researchers admit that this was not fully adhered to as they ‘balanced CCBT groups to

include at least 2 women and 2 men’ introducing selection bias and decreasing the validity of

the study.

Compliance to medication was monitored by pill counts at each visit and reviewing daily

medication logs. The validity of the study would have been increased if blood tests had been

carried out by an independent laboratory to ensure compliance. High degrees of non-

adherence in randomized controlled trials (RCTs) can lead to failure to detect a true treatment

effect (Murali et al. 2017).

Primary outcomes measures were assessed by a blinded independent evaluator increasing

validity. Blinding of data collectors and outcome adjudicators is crucial to ensure unbiased

ascertainment of outcomes (Karanicolas et al. 2010) but the blinding process was not

evaluated which leads to doubts whether blinding was successful.

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Internal validity is questioned in this trial as there are possibilities for bias, furthermore the

duration of the trial lasted only 14 weeks, and therefore results are to be viewed with caution.

Results:

In Clark et al. (2003) social phobia was measured on a social phobia composite which was

based on seven individual social phobia measures. There was a large effect size for Cognitive

therapy (CT) at posttreatment (1.31) and a small treatment effect for Fluoxetine and self-

exposure (0.21) based on Cohen’s (1988) (cited in Clark et al. 2003) threefold classification

of effect size. Rice (2009) teaches that the larger the effect size, the more powerful the

treatment intervention. Paired comparisons indicated that CT was superior to fluoxetine +

Self exposure and Placebo + self-exposure on the social phobia composite scale (group effect

9.5=p<.001.) and all seven individual measures at posttreatment. Surprisingly, there was no

statistical significance between Fluoxetine+ Self-exposure (effect size 0.92) and the control

Placebo+ self-exposure (effect size 0.56), post treatment.

In Nordahl’s et al. (2016) study, the primary outcome was measured by the level of

symptoms on the Fear of Negative Evaluation questionnaire (FNE). There were three

secondary outcome measures; Liebowitz Social Anxiety Scale (LSAS), the Beck Anxiety

Inventory (BAI) and the Inventory of Interpersonal Problems (IIP). This study resulted that

the combination group (Paroxetine and CT) were equal to the Paroxetine group, post

treatment (mean difference = -2.166, p=0.806) on the FNE. At the 12 month follow up there

was no difference between CT and the combination group, however both were more effective

than the placebo and Paroxetine arms. On the secondary measure the LSAS the CT group

alone performed better than any of the other 3 arms at the 12 month follow up. Of great

significance were the recovery rates 68% of the CT group compared to 45% of the

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combination group, 23% in the paroxetine group and 4% in the placebo arm. Effect sizes

were high suggesting both clinical and statistical significance.

Davidson et al. (2004) resulted in Fluoxetine alone producing a p value of <.01 from 0-4

weeks. At the end of treatment (14 weeks) a statistical significance was established in all

arms except the placebo group on the primary outcome Brief Social Phobia Scale (BSPS) and

the secondary outcome Social Phobia and Anxiety Inventory (SPAI) indicating a p value of

<.05 and a confidence interval of 95%. However on the Clinical Global Impressions Scale

(CGI), the second primary outcome, Fluoxetine and the combination of CCBT+FLU were

superior at the end of treatment (p=.01) but no statistical difference for CCBT or CCBT/PBO.

Du Prel et al. (2009) explain that a Confidence Interval (CI) predicts the precision of the

results. If the CI is wide, the estimate of true effect lacks precision and therefore doubts the

treatment effect. If the confidence interval is narrow, precision is high, and we can be more

confident in the results. There was no statistical difference between combined therapies and

monotherapies.

Clinical Bottom line

Based on the evidence from the above three studies, psychological therapy, in particular a

form of CBT, and pharmacological therapy, in particular, a SSRI, are both effective at

reducing symptoms of SAD, however, Cognitive Therapy was superior in the long term in

two out of three of the studies. Interestingly, there was no evidence found that a combination

of both interventions were more effective than their monotherapies on recovery rates.

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Applicability to Practice

In order for a trial to be clinically useful the results must also be relevant to a definable group

of people in a clinical setting, this is known as external validity/applicability (Rothwell 2005).

It is not stated where Clark et al. (2003) trial was carried out, Davidson et al. (2004) study

was based in North Carolina and Philadelphia and the RCT by Nordahl et al. (2016) was

carried out in Norway. The aforementioned increases external validity as results are

applicable to the various nationalities in the local population. All three studies utilised the

DSM and the majority of the outcome measures are utilised in current practice indicating that

the results can be applied to the local population.

Clark et al (2003) and Nordahl et al. (2014) both had small sample sizes assessing

approximately 20 participants per treatment group at post treatment assessments reducing

applicability, as Everitt and Wessely (2004) report that a large sample size is more

representative of the population and minimises random error.

The inclusion and exclusion criteria are well defined for all three studies, participants were

both male and female with a primary diagnosis of social anxiety disorder with Clark et al.

(2004) and Nordahl et al. (2016) both including avoidant personality disorder but excluding

depression. This could limit the generalisability of these results as the majority of the patients

that come in contact with the mental health services in Ireland present with comorbid

psychiatric problems such as depression. This is supported by Magee et al. (1996) who report

that 81% of people that experience social anxiety disorder reported experiencing another

disorder with Katzelnick et al. (2001) adding that up to 35% of sufferers of SAD experience

major depression with SAD preceding depression up to 12 years.

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Despite these results, the majority of patients in the local area being treated for social anxiety

are receiving some form of anti-depressants as the waitlist for CBT is 3 months or more with

Magee et al. (1996) adding that people with social anxiety do not regard themselves as

suffering from an anxiety disorder, but shy, and do not seek help until comorbid disorders

such as depression, affect them.

Implementation

Whilst researching for this critically appraised topic it became apparent the lack of RCT’s

and therefore, systematic reviews, that compare psychological and pharmacological

interventions for SAD. The Cochrane Journal club was suggested by the hospital librarian,

this club is aimed at healthcare professionals and covers a single review of special interest,

selected from the new and updated reviews published in the Cochrane Library. Lawrie et al

(2003) also suggests that mental health professionals establish a local evidence-based

psychiatry journal club (EBPJC) which would develop critical appraisal techniques and

encourage the implementation of evidence based practice.

Grol and Grimshaw (2003) reported that one of the most consistent findings in health services

research is the gap between evidence based practice (EBP) and actual clinical care. Grol and

Wensing (2004) reports that studies in countries such as the United States and the

Netherlands suggest that up to 40% of patients do not receive care according to current

scientific evidence, while 20% or more of the care provided is not needed or potentially

harmful to patients.

In a study carried out by Melnyk et al. (2012) on nurses in the United States, the two most

frequently cited barriers to EBP, were a lack of time and a workplace resistance, mostly from

11

management, to change. This study proposes that EBP mentors work alongside clinicians to

facilitate learning these skills and implement them into practice consistently. Facilitation is

considered necessary for enabling successful implementation and is described by Rycroft-

Malone, (2004) as the process of supporting the implementation of evidence into practice and

support to aid nurses alter their attitudes and ways of working.

Organizations need to consider resources required for EBP as a lack of resources are

unfavorable to the success of implementation (Dogherty et al, 2013), financial, personnel,

equipment, support, access to evidence, and time are all forms of resources. From experience

as a mental health nurse, lack of time to access library facilities and lack of

motivation/support to implement new practice are the main restraining factors for frontline

staff. Thompson et al. (2008) supports this by pointing out that busyness, in the context of

research utilization, includes multiple dimensions such as physical time, but perhaps more

importantly, mental time.

It is evident in practice that mental health nurses are not familiar with CBT techniques or the

benefits despite many years of experience as mental health nurses. Most educational

institutions in Ireland do not provide basic psychological therapy training to mental health

students, however, there is an emphasis placed on pharmacology. It is important that

organizations examine existing resources that could be utilized to promote change, that is,

facilitate nurses to attend training days, encouragement of research, time allocated for

research and encourage staff to return to education on a part time basis by providing

incentives such as; funding, study days and instill hope of post progression/promotion

following their studies.

Lewin’s (1951) (cited in Bowers 2011) proposed a three-step process to change management

which offers a structured approach to understanding and changing behaviour in the workplace.

12

It relates well to healthcare practice, as its three stages of ‘unfreezing’, ‘moving’ and

‘refreezing’ are similar to the healthcare processes of ‘planning’, ‘implementing’ and

‘evaluating’ care. This process is outlined with the clinical bottom line of this critical

appraisal in mind and focusing on the psychological therapy, CBT.

Unfreezing/Planning: Approaching management with the findings of this appraisal that

psychological therapies are more beneficial than pharmacological therapies and the most cost

effective therapy for health services (Mavranezouli 2015). A proposal would be presented to

hold workshops to educate mental health colleagues on the evidence based benefits of CBT

and the basic techniques of CBT. Gage (2013) emphasize that support must be gained from

senior management who have an appropriate area of responsibility, and who would benefit

from this service improvement idea and support the implementation of the project.

Moving/Implementing: Nursing staff acquire basic CBT skills and implement them into daily

practice. Gage (2013) reports that if staff are involved in change from the early stages they

are more likely to feel more invested in assisting with the delivery of the change plan, with

Hall and Hord (2011) adding staff are more likely to accept change than if it is not imposed

on them ‘from above’.

Refreezing/ evaluation: Staff to monitor for a decrease in symptoms of SAD. Parkes and

O’Dell (2015) report that if changes are implemented it is imperative that these changes are

audited to ensure the continued provision of quality care.

If the above implementation plan was a success, Mental Health Nurses could then practice

basic CBT techniques with patients while they await an appointment from a qualified

therapist. As a result, patients would then know what to expect from therapy, attend their

appointment and limit the chance of deterioration. In addition, it may encourage nursing staff

to return to higher education to train as Cognitive Behavioural Psychotherapists.

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Appendix 1: Search Strategies

Search on Medline: After using additional keywords and filters my search finally resulted in 1 text

being retrieved Clark et al (2003) and deemed as appropriate for critical appraisal following the

reading of each abstract. Filters used were: full text, published in peer review journals and that the

keywords would be in the title of the text.

SEARCH MEDLINE: Key Words and Boolean Operator HITS

S1 Social Phobia 3410

S2 Cognitive therapy 21864

S3 Fluoxetine 11846

S4 1 AND 2 AND 3 17

Search on PsycINFO: The key words used were CBT, anxiety and depression. The Boolean operator

AND was used. Filters were: journals, full text and that the keywords would be in the title of the text.

Following inspection of the abstracts one was chosen for critical appraisal (Nordahl et al. 2016)

SEARCH PsycInfo

Key Words and Boolean Operator

HITS

S1 Social Anxiety Disorder 4078

S2 Cognitive therapy 6863

S3 Paroxetine 958

S4 1 AND 2 AND 3 2

14

Search on Science Direct: Filters were: journals, full text, keywords would be in the title of the text

and year limit from 2014-2017 to locate the most recent evidence. Following inspection of the

abstracts none was deemed appropriate for critical appraisal

SEARCH ScienceDirect

Key Words and Boolean Operator

HITS

S1 Social Phobia 2444

S2 AND psychological and Pharmacological

Interventions

331

Search on Cochrane: Following inspection of the abstracts one was chosen for critical appraisal

(Davidson et al. 2004).

SEARCH Cochrane

Key Words and Boolean Operator

HITS

S1 Social Phobia 1120

S2 AND Fluoxetine 33

15

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