Condition category
Mental and Behavioural Disorders
Date applied
31/03/2009
Date assigned
20/10/2009
Last edited
22/03/2016
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

Dr David Veale

ORCID ID

Contact details

Centre for Anxiety Disorders and Trauma
99 Denmark Hill
London
SE5 8AZ
United Kingdom
+44 (0)20 3228 3461
david.veale@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00871143

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of two different versions of cognitive behaviour therapy for body dysmorphic disorder

Acronym

Study hypothesis

The hypotheses to be tested are that:
1. Specific cognitive behavioural therapy (CBT) for body dysmorphic disorder (BDD) will be more effective than non-specific CBT at 12 weeks
2. Treatment effects from specific CBT will be maintained at 1 month, 3 months and 1 year follow-up

Ethics approval

The Joint South London and Maudsley and the Institute of Psychiatry Research Ethics Committee (REC), 23/03/2009, ref: 09/H0807/9

Study design

Single-centre single-blinded parallel-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Body dysmorphic disorder

Intervention

CBT specific for BDD:
A pilot study 12 years ago has demonstrated a significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.

CBT not specific for BDD:
Stress management and cognitive restructuring, which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However, in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.

The treatments are provided over 12 weeks (twice a week for the first 4 weeks and once a week for 8 weeks). For CBT specific to BDD there will be three follow-up sessions at 1 and 3 months and at 1 year, making a maximum total of 19 sessions.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Yale Brown Obsessive Compulsive Scale (modified for BDD) (BDD-YBOCS), which will be done by a blind assessor at 12 weeks.

Secondary outcome measures

Two observer-rated scales:
1. Brown Assessment of Beliefs to measure the strength of conviction in beliefs about being ugly
2. Montgomery Asberg Depression rating scale

Five brief self-rated scales:
1. The Body Image Quality Of Life (BIQL) inventory, which is a disorder-specific quality of life measure and used in BDD
2. Depression (nine-item Patient Health Questionnaire [PHQ9])
3. Anxiety (Generalised Anxiety Disorder Assessment [GAD7])
4. Appearance Anxiety Inventory (AAI)
5. EQ5-D, a measure of health-related quality of life

Patients will be reassessed on all measures at 6 and 12 weeks. Patients in the CBT specific for BDD group will be assessed at 1 month, 3 months and 1 year following treatment. In addition, the PHQ9, GAD7 and AAI are measured weekly for case tracking during treatment. The primary end-point is at 12 weeks. Patient preference as to treatment group and their expectations and beliefs about treatment (pre- and post-) will also be recorded.

Overall trial start date

01/04/2009

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. BDD is the main psychological problem. We will use Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria as BDD does not exist as a separate diagnosis in the International Classification of Disease, version 10 (ICD-10). They may have an additional diagnosis of delusional disorder when it refers to beliefs about being ugly or defective.
2. They must have a total of 24 or more on the twelve-item Yale-Brown Obsessive Compulsive Scale (YBOCS) modified for BDD
3. They may be of either gender but must be 17 years or above
4. They are willing to travel to the treatment centre for weekly sessions
5. They are willing to complete regular questionnaires and be audiotaped for supervision and for listening to enhance their learning
6. They may be taking psychotropic medication so long as it is stabilised and there are no plans to increase the dose

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

44

Participant exclusion criteria

1. They have a current or past diagnosis of schizophrenia, bipolar affective disorder
2. They have current suicidal intent or severe self-neglect that requires hospitalisation
3. They have a current alcohol or substance dependence or anorexia nervosa or borderline personality disorder that requires treatment in its own right
4. They are currently receiving any other form of psychotherapy
5. They have received CBT for BDD in the past 6 months, which is judged as competently delivered and did not respond
6. They cannot speak sufficient English for CBT (assistance will be provided for those who speak English but are unable to read questionnaires)

Recruitment start date

01/04/2009

Recruitment end date

01/04/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Anxiety Disorders and Trauma
London
SE5 8AZ
United Kingdom

Sponsor information

Organisation

Institute of Psychiatry, Kings College London (UK)

Sponsor details

Research Governance/Clinical Trials Facilitator
SLaM/IoP R&D Office
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0251
G.Lambert@iop.kcl.ac.uk

Sponsor type

University/education

Website

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

Funders

Funder type

University/education

Funder name

Institute of Psychiatry, Kings College London (UK) - Biomedical Research Centre for Mental Health (ref: PAXKAYR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

See https://clinicaltrials.gov/ct2/show/results/NCT00871143

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25323062

Publication citations

Additional files

Editorial Notes

22/03/2016: added link to results - basic reporting.