Body Dysmorphic DisordersNCT03221738
Smartphone-Administered App Treatment for Adults With Body Dysmorphic Disorder
A study testing App-Based Cognitive Behavioral Therapy in people with Body Dysmorphic Disorders, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators are developing and testing a Smartphone-based cognitive behavioral therapy (CBT) "app" for body dysmorphic disorder (BDD). The investigators hypothesize that app-based CBT for BDD will be feasible and acceptable to individuals with BDD, and will improve body image concerns and related outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Dysmorphic Disorders
- What is being tested?
- App-Based Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2017to 18 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- At least 18 years of age
- Outpatients
- Meets current diagnosis of primary DSM-5 BDD
- Has score on BDD-YBOCS of ≥ 20
- Currently living in the United States
Who cannot join
- Psychotropic medication changes within 2 months prior to enrollment
- Participants taking psychotropic medication have to have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period
- Participated in CBT for BDD ever during lifetime
- Current substance dependence
- Lifetime bipolar disorder or psychosis
- Acute, active suicidal ideation
Show all 11Show fewer
- Current severe comorbid major depression, defined by a PHQ-9 total score ≥ 20
- Personality disorder that could jeopardize treatment participation (e.g., borderline personality disorder with self-harm)
- Concurrent psychological treatment
- Do not own a supported mobile Smart phone with a data plan (currently iPhone 5S or more recent, running iOS 9 or newer)
- Intellectual disability or other cognitive impairment that would interfere with ability to engage in CBT
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Development of a Cognitive Behavioral Mobile App for Body Dysmorphic Disorder, and Tests of Feasibility, Acceptability, and Preliminary Efficacy
The investigators are developing and testing a Smartphone-based cognitive behavioral therapy (CBT) "app" for body dysmorphic disorder (BDD). The investigators hypothesize that app-based CBT for BDD will be feasible and acceptable to individuals with BDD, and will improve body image concerns and related outcomes.
Read the detailed description
The primary aims of this study are to develop and test the feasibility, acceptability, and preliminary efficacy of a Smartphone-based CBT treatment for adults with BDD. This project aims to solve two healthcare problems: poor access to empirically-supportive treatment for BDD, and challenges of generalizing CBT skills outside therapy sessions. Inadequate treatment access is due to limited professionals offering this specialized treatment, economic barriers, and shame preventing sufferers from seeking in-person care. Mobile app-based CBT would solve this access gap by addressing each of these barriers. Among those who obtain CBT, practicing skills outside of therapy is critical for treatment effectiveness, as BDD symptoms occur around-the-clock and can be most impairing at home. However, BDD patients struggle to use skills without therapists' in-person support. App-based CBT that provides on-hand skills coaching addresses this treatment generalization challenge.
This study involves developing the app-based CBT for BDD treatment, and then investigating the initial feasibility, acceptability, and preliminary efficacy of the app-based treatment in an open pilot trial (N = 10), consisting of 12-weeks of active treatment plus a 6-month follow up period.
- Conditions
- Body Dysmorphic Disorders
- Being tested
- App-Based Cognitive Behavioral Therapy
- Keywords
- BDD
- Medical subject headings
- Body Dysmorphic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-Based Cognitive Behavioral TherapyBehavioural
12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
| Study group | Role | What they receive |
|---|---|---|
| App-Based Cognitive Behavioral Therapy | Experimental | 12-week Smartphone-delivered CBT for BDD. Receives: Behavioral: App-Based Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Completion Rates
Number of subjects who completed the app-based treatment to assess feasibility and acceptability
Measured: Post treatment assessment (12 weeks)
Client Satisfaction Questionnaire (CSQ). This Measure Will be Used to Assess Change Over the Course of Treatment Twice Throughout the Study (Over Approximately 10 Months Total).
The Client Satisfaction Questionnaire (CSQ) is a 25-item self-report questionnaire which assesses the satisfaction with clinical services received. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Measured: Post-treatment assessment (week 12)
Secondary outcomes (1)
Yale Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS). This Measure Will be Used to Assess Change Over the Course of Treatment at Five Time Points Throughout the Study (Over Approximately 10 Months Total).
The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess change in BDD symptoms from baseline to endpoint.
Measured: Post-treatment assessment (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start24 Jul 2017
- Primary completion18 Jan 2019
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Dysmorphic DisordersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Telefónica S.A.
- Responsible party
- Principal investigator, Sabine Wilhelm, PhD, Massachusetts General Hospital
- Investigators
- Sabine Wilhelm, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221738
- Sponsor's protocol ID
- 2017P000293_A
- Status last verified
- Apr 2019
- First submitted
- 12 Jul 2017
- Last updated
- 26 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilhelm S, Weingarden H, Greenberg JL, McCoy TH, Ladis I, Summers BJ, Matic A, Harrison O. Development and Pilot Testing of a Cognitive-Behavioral Therapy Digital Service for Body Dysmorphic Disorder. Behav Ther. 2020 Jan;51(1):15-26. doi: 10.1016/j.beth.2019.03.007. Epub 2019 Aug 7.
PubMed 32005333
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Cognitive Behavioral Mobile App for Body Dysmorphic Disorder, and Tests of Feasibility, Acceptability, and Preliminary Efficacy
- ClinicalTrials.gov ID
- NCT03221738
- Acronym / sponsor ID
- 2017P000293_A
- Conditions
- Body Dysmorphic Disorders
- Keywords
- BDD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Telefónica S.A.
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 19 Jul 2017 (actual)
- Results
- Posted 26 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are developing and testing a Smartphone-based cognitive behavioral therapy (CBT) "app" for body dysmorphic disorder (BDD). The investigators hypothesize that app-based CBT for BDD will be feasible and acceptable to individuals with BDD, and will improve body image concerns and related outcomes.
Detailed description
The primary aims of this study are to develop and test the feasibility, acceptability, and preliminary efficacy of a Smartphone-based CBT treatment for adults with BDD. This project aims to solve two healthcare problems: poor access to empirically-supportive treatment for BDD, and challenges of generalizing CBT skills outside therapy sessions. Inadequate treatment access is due to limited professionals offering this specialized treatment, economic barriers, and shame preventing sufferers from seeking in-person care. Mobile app-based CBT would solve this access gap by addressing each of these barriers. Among those who obtain CBT, practicing skills outside of therapy is critical for treatment effectiveness, as BDD symptoms occur around-the-clock and can be most impairing at home. However, BDD patients struggle to use skills without therapists' in-person support. App-based CBT that provides on-hand skills coaching addresses this treatment generalization challenge.
This study involves developing the app-based CBT for BDD treatment, and then investigating the initial feasibility, acceptability, and preliminary efficacy of the app-based treatment in an open pilot trial (N = 10), consisting of 12-weeks of active treatment plus a 6-month follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| App-Based Cognitive Behavioral Therapy | Experimental | Behavioral: App-Based Cognitive Behavioral Therapy12-week Smartphone-delivered CBT for BDD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Outpatients
- Meets current diagnosis of primary DSM-5 BDD
- Has score on BDD-YBOCS of ≥ 20
- Currently living in the United States
Key exclusion criteria (11 listed)
- Psychotropic medication changes within 2 months prior to enrollment
- Participants taking psychotropic medication have to have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period
- Participated in CBT for BDD ever during lifetime
- Current substance dependence
- Lifetime bipolar disorder or psychosis
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 |
|---|---|---|
| App-Based Cognitive Behavioral Therapy12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills. | Behavioural | App-Based Cognitive Behavioral Therapy |
Primary outcome
Treatment Completion Rates
Time frame: Post treatment assessment (12 weeks)
Number of subjects who completed the app-based treatment to assess feasibility and acceptability
Client Satisfaction Questionnaire (CSQ). This Measure Will be Used to Assess Change Over the Course of Treatment Twice Throughout the Study (Over Approximately 10 Months Total).
Time frame: Post-treatment assessment (week 12)
The Client Satisfaction Questionnaire (CSQ) is a 25-item self-report questionnaire which assesses the satisfaction with clinical services received. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
1 secondary outcome
Yale Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS). This Measure Will be Used to Assess Change Over the Course of Treatment at Five Time Points Throughout the Study (Over Approximately 10 Months Total).
Time frame: Post-treatment assessment (week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32005333Wilhelm S, Weingarden H, Greenberg JL, McCoy TH, Ladis I, Summers BJ, Matic A, Harrison O. Development and Pilot Testing of a Cognitive-Behavioral Therapy Digital Service for Body Dysmorphic Disorder. Behav Ther. 2020 Jan;51(1):15-26. doi: 10.1016/j.beth.2019.03.007. Epub 2019 Aug 7.
- Individual participant dataSharing planned: No
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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, Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-Based Cognitive Behavioral Therapy in people with Body Dysmorphic Disorders, run by Massachusetts General Hospital at 1 site 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 5 inclusion and 11 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 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 26 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Completion Rates (time frame: Post treatment assessment (12 weeks)). The study lists 2 primary outcomes in all. 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 NCT03221738, 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 26 Jun 2019.