Condition category
Mental and Behavioural Disorders
Date applied
30/03/2006
Date assigned
30/03/2006
Last edited
05/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David M Clark

ORCID ID

Contact details

Institute of Psychiatry
Henry Wellcome Building
Department of Psychology
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0245
d.clark@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

069777

Study information

Scientific title

A randomised controlled trial of brief cognitive therapy for social phobia (social anxiety disorder)

Acronym

Study hypothesis

To determine whether a new and brief (seven session), self-study augmented version of cognitive therapy for social phobia is as effective as the established, full length (14 session) treatment programme.

Ethics approval

Research Ethics Committee of the Department of Institute of Psychiatry and South London and Maudsley NHS Trust, ref: 05/Q0706/237

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Social Phobia

Intervention

Patients suffering from social phobia who are referred to the Centre for Anxiety Disorders and Trauma at the Maudsley Hospital will be invited to participate in the trial. Patients who agree to be included will initially be randomly allocated to:
1. Brief (seven sessions), self-study augmented cognitive therapy
2. Full cognitive therapy (14 sessions)
3. A 14 week wait-list control condition

Patients initially allocated to wait will subsequently receive brief or full cognitive therapy (further random allocation). Full cognitive therapy will be identical to the full cognitive therapy programme used in our recent randomised controlled trials. The self-study modules cover all the main steps in therapy and are completed in the days before a treatment session. The modules were developed and refined over a 12 month period in consultation with patients from the Centre for Anxiety Disorders and Trauma.

The aim of the modules is to speed up therapy by allowing therapists to focus more closely on areas that need a therapist's skill. As social phobia is a chronic condition, it is important that treatments have a sustained effect. For this reason, the proposed research trial includes a one year prospective follow-up after the end of treatment. In our previous trials of cognitive therapy, we have found that therapy gains are largely maintained at one year follow-up and we expect the same to be true in this trial. Other assessments will be at pre-treatment, mid-treatment, post-treatment and three month follow-up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The primary outcome measure for the trial is a social phobia composite measure that is created by combining scores from seven independent assessor and patient scales that are well validated measures of social phobia related symptomatology. Scores on each scale are standardised (M = 0, SD = 1) across pre-treatment and post-treatment assessments by converting to Z scores. The composite at each assessment occasion is the mean of the Z scores on that occasion. This procedure has been used in our last two social phobia trials as well as in other trials in the field.

The seven scales that make up the social phobia composite are:
1. The mean assessor rating of social phobia related fear and avoidance from the anxiety disorders interview schedule for DSM-IV
2. Patient completed Social Phobia Scale
3. The Social Interaction Anxiety Scale
4. The Liebowitz Social Anxiety Scale
5. The Social Phobia and Anxiety Inventory
6. The Fear of Negative Evaluation Scale
7. The Social Phobia Weekly Summary Scale

Secondary outcome measures

1. General mood (assessed by the Beck Anxiety Inventory and the Beck Depression Inventory) and Disability (assessed by the Sheehan Disability Scales)
2. The proportion of patients who continue to meet diagnostic criteria for social phobia at post-treatment and follow-up and the proportion of patients who continue to meet diagnostic criteria for avoidant personality disorder at 12 month follow-up

Overall trial start date

14/02/2006

Overall trial end date

01/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (American Psychiatric Association, 1994) criteria for social phobia
2. Duration of at least six months
3. Social phobia considered to be the patient's main problem
4. Age 18 to 65 years
5. No psychotropic medication or on a stable dose for at least two months without symptomatic improvement and willing to keep dosage constant during the trial
6. Agree not to start any additional non-protocol treatment during the trial
7. Willing to accept random allocation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Current alcohol or substance dependency (abuse but not dependency is acceptable)
2. Current or past psychosis
3. Borderline personality disorder (other personality disorders are not a reason for exclusion)
4. Unable to read English
5. Social phobia previously treated with an adequate course of an appropriate course of cognitive behaviour therapy or exposure therapy

Recruitment start date

14/02/2006

Recruitment end date

01/02/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London and the South London and Maudsley NHS Trust (UK)

Sponsor details

Dr Gill Dale
R&D Office
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0675
g.dale@iop.kcl.ac.uk

Sponsor type

Government

Website

http://www.iop.kcl.ac.uk

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21727253

Publication citations

  1. Results

    Stangier U, Schramm E, Heidenreich T, Berger M, Clark DM, Cognitive therapy vs interpersonal psychotherapy in social anxiety disorder: a randomized controlled trial., Arch. Gen. Psychiatry, 2011, 68, 7, 692-700, doi: 10.1001/archgenpsychiatry.2011.67.

Additional files

Editorial Notes