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 of protocol

Not provided at time of registration

Contact information

Prof David M Clark
Scientific

Institute of Psychiatry
Henry Wellcome Building
Department of Psychology
De Crespigny Park
London
SE5 8AF
United Kingdom

Phone	+44 (0)20 7848 0245
Email	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 objectives	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
Health condition(s) or problem(s) studied	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
Completion date	01/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	90
Key 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
Key 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
Date of first enrolment	14/02/2006
Date of final enrolment	01/02/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Psychiatry

London
SE5 8AF
United Kingdom

Sponsor information

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

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