Cognitive therapy for body dysmorphic disorder

ISRCTN	ISRCTN92515063
DOI	https://doi.org/10.1186/ISRCTN92515063
Protocol serial number	DFG project number: 287331963
Sponsor	Deutsche Forschungsgemeinschaft (DFG)
Funder	Deutsche Forschungsgemeinschaft

Submission date: 26/04/2017
Registration date: 12/05/2017
Last edited: 14/10/2022

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

Background and study aims
Body Dysmorphic Disorder (BDD) is an obsessive-compulsive disorder where a person is preoccupied with perceived defects or flaws in their appearance. These defects often appear slight to others. People with BDD believe that specific features of their face, skin or body are disfigured or ugly, and report that the “defect” is on their mind many hours a day. Preoccupation with the “defect” is experienced as uncontrollable, includes recurrent mental images and memories (e.g., teasing), negative emotions, thoughts, beliefs, time-consuming ritualistic behaviors (e.g., mirror checking) and avoidance. People with BDD experience marked distress, handicap, and psychosocial impairments, have high rates of suicide, are often housebound and/or socially isolated, and have difficulties with relationships. They are often too ashamed to reveal their main BDD symptoms and report symptoms of depression and social anxiety. BDD is regarded as rare, but evidence suggests rates of 0.7-2.9% in the community, and higher rates in cosmetic surgery and dermatology settings. One way of treating BDD is through cognitive therapy (CT), a type of therapy which works on changing emotions, thoughts, beliefs, attention, perception, images, memories and behaviors. However, so far there is only one study showing how well some of the CT interventions work for adults. Therefore, the aim of this study is to find out how well CT interventions help people with BDD by reducing BDD symptoms and improving their mental health.

Who can participate?
Patients aged 18-70 with BDD

What does the study involve?
Participants are randomly allocated to either receive 20 sessions of CT treatment (25x50 units) over 9 months, or to be put on a waiting list. CT involves six phases that explore different processes that maintain the disorder, change their cognitive and emotional processes (attention, perception, images, memories, emotions, thoughts and beliefs), promote healthy behaviors and relationships, and prevent relapsing. Those in the waiting list group have to wait for 3 months. After this period they also receive CT. Participants are assessed during treatment (12 weeks, 24 weeks), after treatment, and are followed up 3 and 6 months after the treatment to assess their symptoms and overall mental health.

What are the possible benefits and risks of participating?
Participants may benefit from a reduction in BDD symptoms. There are no direct risks of participating.

Where is the study run from?
Goethe University Frankfurt (Germany)

When is the study starting and how long is it expected to run for?
March 2016 to March 2021

Who is funding the study?
German Research Foundation (Germany)

Who is the main contact?
Dr Viktoria Ritter
Ritter@psych.uni-frankfurt.de

Contact information

Dr Viktoria Ritter
Scientific

Varrentrappstr. 40-42
Frankfurt
60486
Germany

Phone	+49 (0)69 798 25357
Email	Ritter@psych.uni-frankfurt.de

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Cognitive Therapy for Body Dysmorphic Disorder (CT-BDD): a randomized controlled trial
Study acronym	CT-BDD
Study objectives	Efficacy of cognitive therapy (CT) vs. waitlist (WL) in body dysmorphic disorder concerning improvements in BDD symptom severity and associated features (e.g., insight, depression, psychological functioning) – named hypothesis A1. The first add-on study (named B1) of this randomized controlled trial will be studying changes in emotion regulation, and attachment characteristics as differential predictors of treatment outcome in patients with body dysmorphic disorder who are treated with cognitive therapy (resp. waitlist). The second add-on study (named C1) of this randomized controlled trial will be studying implicit and explicit shame and social pain in patients with body dysmorphic disorder who are treated with cognitive therapy (resp. waitlist).
Ethics approval(s)	Ethics Committee of the Medical Faculty of the Goethe University of Frankfurt, 25/10/2015, ref: 239/15
Health condition(s) or problem(s) studied	Body dysmorphic disorder
Intervention	Current interventions as of 17/08/2021: Thirty-eight adults with a primary diagnosis of BDD will be randomized to 20 sessions (25x50 units) of individual CT-BDD over 9 months or to a 3-month waitlist control group in a ratio of 1:1. The random allocation sequence is generated by an urn randomization program (Stout et al., 1994; Wei, 1978). Randomization is stratified by pretreatment delusionality (as assessed by the BABS). Cognitive therapy for BDD (CT-BDD) includes interventions that aim at modifying biased appearance-related cognitive and emotional processes such as attention, perception, mental imagery, memory, interpretation and dysfunctional behaviors (e.g., rituals, safety behaviors). CT-BDD utilizes interventions for BDD patients (Attentional Training, Perceptual Retraining with Mirror Feedback, Video Feedback, Imagery Rescripting, Behavioral Experiments and Cognitive Restructuring) and additional modules (e.g., Skin Picking, Surgery Seeking). Outcome measures will be completed at pretreatment, every 3 months at intervention phase (at 12- and 24-week), at post treatment (resp. post-waitlist), and at 3- and 6-month follow-up. Treatment response is defined by a BDD-YBOCS reduction ≥30% from baseline. Previous interventions: Thirty-eight adults with a primary diagnosis of BDD will be randomized to 25 (+5) sessions of individual CT-BDD over 10 months or to a 3-month waitlist control group in a ratio of 1:1. The random allocation sequence is generated by an urn randomization program (Stout et al., 1994; Wei, 1978). Randomization is stratified by pretreatment delusionality (as assessed by the BABS). Cognitive therapy for BDD (CT-BDD) includes interventions that aim at modifying biased appearance-related cognitive and emotional processes such as attention, perception, mental imagery, memory, interpretation and dysfunctional behaviors (e.g., rituals, safety behaviors). CT-BDD utilizes interventions for BDD patients (Attentional Training, Perceptual Retraining with Mirror Feedback, Video Feedback, Imagery Rescripting, Behavioral Experiments and Cognitive Restructuring) and additional modules (e.g., Skin Picking, Surgery Seeking). Outcome measures will be completed at pretreatment, every 3 months at intervention phase (at 12- and 24-week), at post treatment (resp. post-waitlist), and at 3- and 6-month follow-up. Treatment response is defined by a BDD-YBOCS reduction ≥30% from baseline.
Intervention type	Other
Primary outcome measure(s)	For A1: 1. BDD symptom severity, measured using the clinician-administered Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive-Compulsive Scale (BDD-YBOCS) 2. BDD diagnosis, measured using the clinician-administered BDD Diagnostic Module (BDDDM) Measured at pretreatment, 12 weeks/post-WL, 24 weeks, post treatment, 3- and 6-months follow-up
Key secondary outcome measure(s)	For A1: 1. Insight, measured using the Brown Assessment of Beliefs Scale (BABS) at pre, 12-weeks/post-WL, 24 weeks, post, 3- and 6-month follow-up 2. Depression, measured using the Quick Inventory of Depressive Symptoms (QUIDS-C), Beck Depression Inventory-II (BDI-II) at pre, 12-weeks/post-WL, 24 weeks, post, 3- and 6-month follow-up 3. Psychosocial functioning, measured using the Global Assessment of Functioning Scale (GAF) at pre, 12-weeks/post-WL, 24 weeks, post, 3- and 6-month follow-up 4. Body dysmorphic concerns, measured using the Body Dysmorphic Symptoms Symptoms Inventory, Fragebogen körperdysmorpher Symptome (FKS) at pre, 12-weeks/post-WL, 24 weeks, post, 3- and 6-month follow-up 5. General symptomatology, measured using the Brief Symptom Inventory (BSI) at pre, 12-weeks/post-WL, 24 weeks, post, 3- and 6-month follow-up 6. Quality of life, measured using the EUROHIS Quality-of-Life Index (EUROHIS-QOL) at pre, 12-weeks/post-WL, 24 weeks, post, 3- and 6-month follow-up For B1: 1. Emotion regulation, measured using the clinician-administered Operationalized Skills Assessment Inventory, Emotion Regulation adapted for BDD (OFD-ER-BDD) at pre, 12 weeks/post-WL, post 2. Attachment characteristics, measured using the clinician-administered Adult Attachment Interview, Erwachsenen-Bindungsprototypen-Rating (EBPR-BI) at pre 3. Self-reported attachment, measured using the self-report questionnaire Experiences in Close Relationships-Revised (ECR-R) at pre, 12 weeks/post-WL, 24 weeks, post, 3- and 6-months follow-up For C1: 1. Implicit shame, measured using an Implicit Association Test (IAT) at pre, post-WL, post 2. Explicit shame, measured using the Body-Focused Shame and Guilt Scale (BFSGS) at pre, post-WL, post 3. Social pain, measured using the Cyberball Paradigm and the self-report questionnaire Social Pain Questionnaire (SPQ) at pre, post-WL, post
Completion date	01/03/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	38
Total final enrolment	40
Key inclusion criteria	1. Primary diagnosis of body dysmorphic disorder (BDD) according to the Body Dysmorphic Disorder Diagnostic Module (BDDDM adapted for DSM-5), the Structured Interview for Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition (SCID-I DSM-5) and the Yale-Brown Obsessive-Compulsive Scale Modified for BDD (BDD-YBOCS) ≥ 20 2. BDD symptoms for at least 6 months prior to participation 3. Age 18-70 years 4. Either no psychotropic medication or, if taking psychotropic medication, be on a stable dose for at least 2 months prior to initial evaluation and agreement not to change the medication during the study 5. Written informed consent
Key exclusion criteria	1. Acute suicidality 2. Psychotic disorder (excluding delusional BDD) 3. Bipolar disorder 4. Alcohol or substance dependence within the last 3 months 5. Borderline personality disorder 6. Prominent risk of self-harm 7. Body image/weight concerns accounted primarily by an eating disorder 8. Organic mental disorder 9. Severe medical conditions 10. Concurrent psychotherapeutic treatment (e.g., psychodynamic)
Date of first enrolment	01/09/2016
Date of final enrolment	30/09/2019

Locations

Countries of recruitment

Germany

Study participating centre

Clinical Psychology and Psychotherapy

Varrentrappstr. 40-42
Frankfurt
60 486
Germany

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	The datasets generated and/or analysed during the current study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		27/07/2022	14/10/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/10/2022: Publication reference added.
17/08/2021: The following changes were made to the trial record:
1. The protocol/serial number was changed from DFG RI 2571/3-1 to DFG project number: 287331963 2. The Interventions were updated.
3. The plain English summary was updated to reflect the changes above.
16/08/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2016 to 01/09/2016.
2. The recruitment end date was changed from 31/03/2020 to 30/09/2019.
19/03/2021: The following changes were made to the trial record:
1. Total final enrolment added.
2. The recruitment end date was changed from 01/06/2018 to 31/03/2020.
3. The overall trial end date was changed from 28/02/2019 to 01/03/2021.
4. The intention to publish date was changed from 28/02/2020 to 31/12/2021.