Body Dysmorphic DisorderNCT00106223
Treatment Study Investigating New Cognitive Behavioral Therapy Treatment Manual for Body Dysmorphic Disorder
A study testing Cognitive behavioral therapy (CBT) in people with Body Dysmorphic Disorder and Somatoform Disorders, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
In an earlier phase of this study, a cognitive behavioral therapy (CBT) manual to treat body dysmorphic disorder (BDD) symptoms was developed. We are currently implementing this manual-based treatment to validate its effectiveness in patients with BDD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Dysmorphic Disorder, Somatoform Disorders
- What is being tested?
- Cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2004to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of BDD for at least 6 months prior to study entry
- Score higher than 23 on BDD Yale-Brown Obsessive Compulsive Scale
- Live within driving distance of Boston, MA or Providence, RI
Who cannot join
- Any psychiatric diagnoses other than BDD
- Alcohol abuse or dependence within 3 months prior to study entry
- Suicidal or homicidal
- Psychotropic medication within 2 months prior to study entry
Trial locations and contacts
2 sites in 1 country.
United States2 sites
BDD Clinic, Massachusetts General Hospital
Charlestown, Massachusetts, 02129
Body Image Program, Butler Hospital
Providence, Rhode Island, 02906
About this study
Official title: A Randomized Waitlist Controlled Treatment Trial Investigating CBT for Body Dysmorphic Disorder
In an earlier phase of this study, a cognitive behavioral therapy (CBT) manual to treat body dysmorphic disorder (BDD) symptoms was developed. We are currently implementing this manual-based treatment to validate its effectiveness in patients with BDD.
Read the detailed description
BDD is a disease that involves preoccupation with imagined or minor physical flaws. The condition often begins in adolescence and, if left untreated, can cause significant social, emotional, and occupational distress. Within the last decade, BDD has received increased attention, and various modes of treatment have been utilized and evaluated. CBT has been found to be a more effective form of treatment than other types of psychotherapy. In this study, we have created a new CBT treatment manual and are currently implementing it to evaluate its effectiveness in patients with BDD. The utility of this manual for different populations will also be evaluated, and adherence and competence measures to assess CBT delivery will be developed.
This study will last 24 weeks. Participants will be randomly assigned (like the flip of a coin) to either start CBT treatment immediately or to a waitlist group, which would require a 3-month wait without treatment before beginning treatment for this study. Participants have a 50-50 chance of being in either group. Participants will receive a total of 22 sessions of individual, manual-based CBT. The CBT sessions will occur weekly during the course of the study. During the sessions, participants will receive education about BDD and CBT, engage in activities that help them confront their BDD, learn new ways of thinking about body image, and learn relapse prevention techniques. Self-report scales will be used to assess participants.
- Conditions
- Body Dysmorphic Disorder, Somatoform Disorders
- Being tested
- Cognitive behavioral therapy (CBT)
- Keywords
- Cognitive Behavioral Therapy, CBT, BDD, Body dysmorphic disorder
- Medical subject headings
- Body Dysmorphic Disorders, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (CBT)Behavioural
Also called CBT
Participants will receive a total of 22 sessions of individual, manual-based CBT. The CBT sessions will occur weekly during the course of the study. During the sessions, participants will receive education about BDD and CBT, engage in activities that help them confront their BDD, learn new ways of thinking about body image, and learn relapse prevention techniques.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group receiving immediate treatment with cognitive behavioral therapy Receives: Behavioral: Cognitive behavioral therapy (CBT) |
| 2 | Active comparator | Waitlist control group to begin CBT 3 months after other CBT group begins treatment Receives: Behavioral: Cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body dysmorphic disorder symptoms
Measured: Measured at Months 6 and 9
Secondary outcomes (3)
Functioning and life satisfaction
Measured: Measured at Months 6 and 9
Depressive symptoms
Measured: Measured at Months 6 and 9
Anxiety symptoms
Measured: Measured at Months 6 and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2005 (estimated)
- Study startApr 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Dysmorphic DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sabine Wilhelm, PhD, Massachusetts General Hospital
- Investigators
- Sabine Wilhelm, PhD, Principal investigator, BDD Clinic Director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106223
- Sponsor's protocol ID
- R34MH070490
- Other IDs
- R34MH070490, 2004-P-000478/7, DATR A2-AIR
- Status last verified
- Jun 2026
- First submitted
- 21 Mar 2005
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fang A, Steketee G, Keshaviah A, Didie E, Phillips KA, Wilhelm S. Mechanisms of Change in Cognitive Behavioral Therapy for Body Dysmorphic Disorder. Cognit Ther Res. 2020 Jun;44(3):596-610. doi: 10.1007/s10608-020-10080-w. Epub 2020 Feb 4.
PubMed 38031584
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Waitlist Controlled Treatment Trial Investigating CBT for Body Dysmorphic Disorder
- ClinicalTrials.gov ID
- NCT00106223
- Acronym / sponsor ID
- R34MH070490
- Conditions
- Body Dysmorphic Disorder, Somatoform Disorders
- Keywords
- Cognitive Behavioral Therapy, CBT, BDD, Body dysmorphic disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In an earlier phase of this study, a cognitive behavioral therapy (CBT) manual to treat body dysmorphic disorder (BDD) symptoms was developed. We are currently implementing this manual-based treatment to validate its effectiveness in patients with BDD.
Detailed description
BDD is a disease that involves preoccupation with imagined or minor physical flaws. The condition often begins in adolescence and, if left untreated, can cause significant social, emotional, and occupational distress. Within the last decade, BDD has received increased attention, and various modes of treatment have been utilized and evaluated. CBT has been found to be a more effective form of treatment than other types of psychotherapy. In this study, we have created a new CBT treatment manual and are currently implementing it to evaluate its effectiveness in patients with BDD. The utility of this manual for different populations will also be evaluated, and adherence and competence measures to assess CBT delivery will be developed.
This study will last 24 weeks. Participants will be randomly assigned (like the flip of a coin) to either start CBT treatment immediately or to a waitlist group, which would require a 3-month wait without treatment before beginning treatment for this study. Participants have a 50-50 chance of being in either group. Participants will receive a total of 22 sessions of individual, manual-based CBT. The CBT sessions will occur weekly during the course of the study. During the sessions, participants will receive education about BDD and CBT, engage in activities that help them confront their BDD, learn new ways of thinking about body image, and learn relapse prevention techniques. Self-report scales will be used to assess participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive behavioral therapy (CBT)Group receiving immediate treatment with cognitive behavioral therapy |
| 2 | Active comparator | Behavioral: Cognitive behavioral therapy (CBT)Waitlist control group to begin CBT 3 months after other CBT group begins treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DSM-IV diagnosis of BDD for at least 6 months prior to study entry
- Score higher than 23 on BDD Yale-Brown Obsessive Compulsive Scale
- Live within driving distance of Boston, MA or Providence, RI
Key exclusion criteria (4 listed)
- Any psychiatric diagnoses other than BDD
- Alcohol abuse or dependence within 3 months prior to study entry
- Suicidal or homicidal
- Psychotropic medication within 2 months prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapy (CBT)Also: CBTParticipants will receive a total of 22 sessions of individual, manual-based CBT. The CBT sessions will occur weekly during the course of the study. During the sessions, participants will receive education about BDD and CBT, engage in activities that help them confront their BDD, learn new ways of thinking about body image, and learn relapse prevention techniques. | Behavioural | 1, 2 |
Primary outcome
Body dysmorphic disorder symptoms
Time frame: Measured at Months 6 and 9
3 secondary outcomes
Functioning and life satisfaction
Time frame: Measured at Months 6 and 9
Depressive symptoms
Time frame: Measured at Months 6 and 9
Anxiety symptoms
Time frame: Measured at Months 6 and 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 38031584Fang A, Steketee G, Keshaviah A, Didie E, Phillips KA, Wilhelm S. Mechanisms of Change in Cognitive Behavioral Therapy for Body Dysmorphic Disorder. Cognit Ther Res. 2020 Jun;44(3):596-610. doi: 10.1007/s10608-020-10080-w. Epub 2020 Feb 4.
- Click here for information on the Body Dysmorphic Disorder Clinic, Massachusetts General Hospital Web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Wilhelm, PhD principal investigator
BDD Clinic Director, Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy (CBT) in people with Body Dysmorphic Disorder and Somatoform Disorders, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body dysmorphic disorder symptoms (time frame: Measured at Months 6 and 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00106223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.