ClinicalTrials.gg
CompletedNCT00106223Updated Jul 2, 2026

Treatment Study Investigating New Cognitive Behavioral Therapy Treatment Manual for Body Dysmorphic Disorder

An interventional study of Cognitive behavioral therapy (CBT) in Body Dysmorphic Disorder and Somatoform Disorders, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Body Dysmorphic Disorder
  • Somatoform Disorders

Keywords

  • Cognitive Behavioral Therapy
  • CBT
  • BDD
  • Body dysmorphic disorder
03

In context

Body Dysmorphic Disorders

56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.

This study's enrollment of 36 is below the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.

Browse Body Dysmorphic Disorders studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    1

    Group receiving immediate treatment with cognitive behavioral therapy

    Behavioral: Cognitive behavioral therapy (CBT)

  • Active comparator
    2

    Waitlist control group to begin CBT 3 months after other CBT group begins treatment

    Behavioral: Cognitive behavioral therapy (CBT)

Interventions

  • BehavioralCognitive behavioral therapy (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.

    Also known as: CBT

06

What researchers measure

Primary outcomes

  1. Body dysmorphic disorder symptoms

    Time frame: Measured at Months 6 and 9

Secondary outcomes

  1. Functioning and life satisfaction

    Time frame: Measured at Months 6 and 9

  2. Depressive symptoms

    Time frame: Measured at Months 6 and 9

  3. Anxiety symptoms

    Time frame: Measured at Months 6 and 9

07

Study locations

2 sites
  • BDD Clinic, Massachusetts General Hospital
    Charlestown, Massachusetts 02129, United States
  • Body Image Program, Butler Hospital
    Providence, Rhode Island 02906, United States
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2004, a primary completion of Dec 2008 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 21, 2005
First posted
Mar 22, 2005
Start
Apr 2004
Primary completionActual
Dec 2008
CompletionActual
Dec 2008
Last update
Jul 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00106223
Responsible party
Sabine Wilhelm, PhD (PhD, Massachusetts General Hospital) — Principal investigator
First posted
Mar 22, 2005
Start date
Apr 2004
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Jul 2, 2026

Study contacts

Sabine Wilhelm, PhD
principal investigator · BDD Clinic Director, Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion