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
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
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
-
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.