NCT02307097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

1.8 years

First QC Date

November 30, 2014

Last Update Submit

October 9, 2017

Conditions

BibliotherapySocial Anxiety DisorderCognitive Behavioral Therapy

Keywords

Randomised Controlled TrialCognitive-Behavioural BibliotherapySocial Anxiety DisorderCognitive-Behavioural TherapyIAPT

Outcome Measures

Primary Outcomes (3)

  • IAPT Standard Minimum Data Set (MDS)

    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.

    2 minutes

  • The Social Phobia Inventory (SPIN; Connor, 2000)

    The SPIN will assess the main spectrum of social anxiety disorder such as fear, avoidance, and physiological symptoms.

    2 minutes

  • The Social Participation & Satisfaction Questionnaire (SPSQ; Alden & Taylor, 2011)

    The SPSQ will assess the degree by which the participant is participating is social activity, and relationship satisfaction.

    2 minutes

Secondary Outcomes (5)

  • 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 Behaviour Questionnaire (SBQ; Clark et al., 2006)

    2 minutes

  • Social Phobia Cognitions Questionnaire (SPC; Clark et al., 2006)

    2 minutes

  • Anticipatory Processing Questionnaire (APQ; Vassilopoulos, 2004) and Post-Event Processing Questionnaire-Revised (PEPQ-R; McEvoy & Kingsep, 2006)

    2 minutes

Other Outcomes (3)

  • A written answer to the question "What have I learnt?" will assess treatment compliance.

    5 minutes

  • A semi-structured interview of patients' experiences.

    10 minutes

  • The number of high-intensity CBT sessions required following CBB will be recorded.

    0 minutes

Study Arms (3)

CBB

EXPERIMENTAL
Procedure: Cognitive-Behavioural Bibliotherapy

CBT

EXPERIMENTAL
Procedure: Cognitive-Behavioural Therapy

WAIT

ACTIVE COMPARATOR
Other: WAIT

Interventions

Cognitive-Behavioural BibliotherapyPROCEDURE
CBB
Cognitive-Behavioural TherapyPROCEDURE
CBT
WAITOTHER
WAIT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Talking Change (Solent NHS Trust)

Portsmouth, Hampshire, PO4 8TA, United Kingdom

Location

Related Publications (5)

  • Abramowitz JS, Moore EL, Braddock AE, Harrington DL. Self-help cognitive-behavioral therapy with minimal therapist contact for social phobia: a controlled trial. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):98-105. doi: 10.1016/j.jbtep.2008.04.004. Epub 2008 Apr 26.

    PMID: 18514614BACKGROUND

  • Clark, D. M., & Wells, A. (1995). A cognitive model of social phobia. In R. Heimberg, M. Liebowitz, D. A. Hope, & F. R. Schneier (Eds.), Social phobia: Diagnosis, assessment, and treatment (pp. 69-93). New York: Guilford Press.

    BACKGROUND

  • Butler, G. (2009). Overcoming Social Anxiety & Shyness. London: Robinson Publishing.

    BACKGROUND

  • Carlbring P, Gunnarsdottir M, Hedensjo L, Andersson G, Ekselius L, Furmark T. Treatment of social phobia: randomised trial of internet-delivered cognitive-behavioural therapy with telephone support. Br J Psychiatry. 2007 Feb;190:123-8. doi: 10.1192/bjp.bp.105.020107.

    PMID: 17267928BACKGROUND

  • Mayo-Wilson E, Dias S, Mavranezouli I, Kew K, Clark DM, Ades AE, Pilling S. Psychological and pharmacological interventions for social anxiety disorder in adults: a systematic review and network meta-analysis. Lancet Psychiatry. 2014 Oct;1(5):368-76. doi: 10.1016/S2215-0366(14)70329-3. Epub 2014 Oct 7.

    PMID: 26361000BACKGROUND

Related Links

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Miles D Wrightman, MSc

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Professor David M Clark, DPhil

    University of Oxford

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2014

First Posted

December 4, 2014

Study Start

January 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 10, 2017

Record last verified: 2017-10

Locations

GB(1)