A randomised controlled trial of brief cognitive therapy for social phobia (social anxiety disorder)
| ISRCTN | ISRCTN11178360 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11178360 |
| Secondary identifying numbers | 069777 |
- Submission date
- 30/03/2006
- Registration date
- 30/03/2006
- Last edited
- 05/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof David M Clark
Scientific
Scientific
Institute of Psychiatry
Henry Wellcome Building
Department of Psychology
De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7848 0245 |
|---|---|
| d.clark@iop.kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A randomised controlled trial of brief cognitive therapy for social phobia (social anxiety disorder) |
| 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(s) | Research Ethics Committee of the Department of Institute of Psychiatry and South London and Maudsley NHS Trust, ref: 05/Q0706/237 |
| 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 |
| Primary outcome measure | 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 study start date | 14/02/2006 |
| Overall study end date | 01/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| 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 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
- England
- United Kingdom
Study participating centre
Institute of Psychiatry
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
King's College London and the South London and Maudsley NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Dr Gill Dale, R&D Office
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom
| Phone | +44 (0)20 7848 0675 |
|---|---|
| g.dale@iop.kcl.ac.uk | |
| Website | http://www.iop.kcl.ac.uk |
"ROR" |
https://ror.org/015803449 |
Funders
Funder type
Charity
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2011 | Yes | No |
