Randomised Controlled Trial of Cognitive-Behavioural Bibliotherapy (CBB) for Social Anxiety Disorder as a Prelude to High-Intensity Cognitive-Behavioural Therapy (CBT) in a Local IAPT Service.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Solent NHS Trust
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- The Social Participation & Satisfaction Questionnaire (SPSQ; Alden & Taylor, 2011)
Study Overview
Brief Summary
The efficacy of high-intensity Cognitive-Behavioural Therapy (CBT) for social anxiety disorder is well established (Mayo-Wilson et al., 2014) and it is recommended by the National Institute of Health and Clinical Excellence (NICE) as the first-line psychological intervention for social anxiety disorder. The treatment aims to modify several maintenance factors (e.g., self-focused attention) that are specified in cognitive models of social anxiety disorder (e.g., Clark & Wells, 1995).
Cognitive-behavioural self-help treatments for social anxiety disorder have been developed to overcome various accessibility issues (e.g., long wait-lists, and the patient's need to avoid social situations, etc) associated with high-intensity CBT (Abramowitz et al., 2009; Carlbring et al., 2007) but a recent network meta-analysis (Mayo-Wilson et al., 2014) identified the former as less cost-effective than the later and thus, they are not recommended as standalone treatments.
However, the potential benefit of cognitive-behavioural self-help treatments for social anxiety disorder within a stepped-care recovery model as a prelude to high-intensity CBT has not been formally evaluated.
The aim of this study is to evaluate a seminal Cognitive-Behavioural Bibliotherapy* (CBB; "pure self-help" book) - 'Overcoming Social Anxiety & Shyness' (Butler, 2009) - for patients with social anxiety disorder while on the wait-list for high-intensity CBT within an Improving Access to Psychological Therapies (IAPT) service, and to determine if some patients recover from CBB alone or whether there may be a reduction in the average number of high-intensity CBT sessions for those patients who subsequently require further treatment.
The study is funded by Constable & Robinson, Kellogg College (University of Oxford) and Talking Change (Solent NHS Trust).
* The Reading Well Books on Prescription scheme with funding from the Arts Council England enables general practitioners (GPs) and mental health professionals to prescribe seminal CBBs for patients with mood and anxiety disorders. The books are accessed free of charge via local libraries. The scheme works within NICE guidelines and it is support by the Royal Colleges of GPs, Nursing and Psychiatrists, the British Association for Behavioural and Cognitive Psychotherapies and the Department of Health through its IAPT programme.
Detailed Description
P A R T I C I P A N T S
Patients will be recruited within an Improving Access to Psychological Therapies (IAPT) service: 'Talking Change' (Portsmouth). Advertisement for the study will be distributed locally, through social media and via the 'Talking Change' Internet website.
It is generally accepted that social anxiety disorder is a chronic condition and significant change in the wait-list does not occur. Hence, because the study aims to explore predicators of treatment response, a priori power analyses determined that approximately 114 patients randomly assigned for twelve-weeks at a ratio of 2:1 would provide sufficient power for statistical analyses; seventy-six and thirty-eight patients in the Cognitive-Behavioural Bibliotherapy (CBB) and wait-list control (WAIT) group, respectively.
Randomisation will be conducted by someone unassociated with the study using sealed envelopes.
M E A S U R E S
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 18 years of age;
- •≥ 19 points on the Social Phobia Inventory (SPIN; Connor, 2000);
- •Meets full Diagnostic and Statistical Manual of Mental Disorders (5th ed.;
- •DSM-5; American Psychiatric Association, 2013) criteria for social anxiety disorder;
- •Social anxiety is the primary disorder requiring treatment;
- •Sufficient reading and writing ability (cut-off to be decided);
- •English is first language;
- •Stable dose of antidepressant medication for at least two months.
- •Patients who do not meet the inclusion criteria will be offered alternative treatment within the service or referred elsewhere as required.
Exclusion Criteria
- •If co-morbidity present, social anxiety disorder is not the primary problem;
- •Another disorder (e.g., depression) requires urgent treatment in it's own right;
- •Past or present history of psychosis, borderline personality disorder, or bipolar disorder;
- •Risk to themselves or others; Drug and alcohol misuse;
- •Previous high-intensity Cognitive-Behavioural Therapy (CBT) for social anxiety disorder;
- •On-going psychological therapy;
- •Engaging in another research trial;
- •Psychotropic medication.
- •Patients who meet the exclusion criteria will be offered alternative treatment within the service or referred elsewhere as required.
Arms & Interventions
WAIT
Intervention: WAIT (Other)
CBB
Intervention: Cognitive-Behavioural Bibliotherapy (Procedure)
CBT
Intervention: Cognitive-Behavioural Therapy (Procedure)
Outcomes
Primary Outcomes
The Social Participation & Satisfaction Questionnaire (SPSQ; Alden & Taylor, 2011)
Time Frame: 2 minutes
The SPSQ will assess the degree by which the participant is participating is social activity, and relationship satisfaction.
IAPT Standard Minimum Data Set (MDS)
Time Frame: 2 minutes
The brief versions of the Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, \& Williams, 2001) and the Generalised Anxiety Disorder Questionnaire (GAD-7; Spitzer, Kroenke, Williams, \& Löwe, 2006) will assess mood and generalised anxiety, respectively. The Work and Social Adjustment Scale (WSAS; Marks, 1986) will assess functional impairment attributable to an identified problem. The Phobia Scales is a non-validated phobia screener of social phobia, panic disorder/agoraphobia, and specific phobia avoidance.
The Social Phobia Inventory (SPIN; Connor, 2000)
Time Frame: 2 minutes
The SPIN will assess the main spectrum of social anxiety disorder such as fear, avoidance, and physiological symptoms.
Secondary Outcomes
- Anticipatory Processing Questionnaire (APQ; Vassilopoulos, 2004) and Post-Event Processing Questionnaire-Revised (PEPQ-R; McEvoy & Kingsep, 2006)(2 minutes)
- Social Behaviour Questionnaire (SBQ; Clark et al., 2006)(2 minutes)
- Liebowitz Social Anxiety Scale (LSAS-SR; Baker, Heinrich, Kim, & Hofmann, 2002; Liebowitz, 1987)(2 minutes)
- Self-Focused Attention Scale (SFA; Bögels, Alberts, & de Jong, 1996)(2 minutes)
- Social Phobia Cognitions Questionnaire (SPC; Clark et al., 2006)(2 minutes)