Body Dysmorphic Disorders
Conditions
Keywords
BDD
Brief 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.
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.
Interventions
BEHAVIORALApp-Based Cognitive Behavioral Therapy
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.
Sponsors
Telefónica S.A.
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase 1B (open pilot trial): Inclusion Criteria: * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Completion Rates | 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Post-treatment assessment (week 12) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| App-Based Cognitive Behavioral Therapy 12-week Smartphone-delivered CBT for BDD.
App-Based Cognitive Behavioral Therapy: 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | App-Based Cognitive Behavioral Therapy |
|---|---|
| Age, Continuous | 27.6 years STANDARD_DEVIATION 5.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 6 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: Post-treatment assessment (week 12)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App-Based Cognitive Behavioral Therapy | 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). | 27.90 score on a scale | Standard Deviation 3.51 |
Primary
Treatment Completion Rates
Number of subjects who completed the app-based treatment to assess feasibility and acceptability
Time frame: Post treatment assessment (12 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| App-Based Cognitive Behavioral Therapy | Treatment Completion Rates | 10 Participants |
Secondary
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.
Time frame: Post-treatment assessment (week 12)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App-Based Cognitive Behavioral Therapy | 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). | 16.50 score on a scale | Standard Deviation 3.63 |