Body Dysmorphic DisorderNCT02635152
Interpretation Bias Modification for Body Dysmorphic Disorder
A study testing Interpretation Bias Modification and Progressive Muscle Relaxation in people with Body Dysmorphic Disorder, run by Florida State University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a computerized intervention designed to reduce appearance and evaluation related interpretation biases will reduce symptoms associated with body dysmorphic disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Body Dysmorphic Disorder
- What is being tested?
- Interpretation Bias Modification and Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Mar 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of Body Dysmorphic Disorder according to DSM-5 criteria
- BDD-YBOCS score greater than or equal to 20
- Fluent in English
- No significant physical defect or flaw in appearance (e.g., disfiguration)
Who cannot join
- History of psychotic disorder, bipolar disorder, borderline personality disorder
- Current substance use disorder
- Unstable medication status (i.e. change in medication within the last month)
- Concurrent psychotherapy for appearance concerns
- Active and clinically significant suicidality
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University Psychology Department
Tallahassee, Florida, 32304
About this study
Official title: Evaluation of an Internet-Based Treatment for Body Dysmorphic Disorder
The purpose of this study is to determine whether a computerized intervention designed to reduce appearance and evaluation related interpretation biases will reduce symptoms associated with body dysmorphic disorder.
Read the detailed description
The present study aims to examine the feasibility of a remote treatment for body dysmorphic disorder delivered via the Internet. To evaluate the efficacy of the IBM protocol we have developed in reducing negative appearance and evaluative related interpretations, we will conduct a two-arm randomized controlled trial over the internet. Individuals with a diagnosis of body dysmorphic disorder (N = 40) will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each condition will consist of eight 10-25 minute treatment sessions. Participants will complete two sessions per week for four weeks and will be administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up. We hypothesize that: 1) IBM will lead to greater reductions in BDD symptoms than the PMR condition; 2) IBM will lead to greater reductions in depression, anxiety and suicidal ideation than the PMR condition; 3) IBM will lead to greater reductions in threat interpretations and greater increases in benign interpretations than the PMR condition; 4) The effects of condition on BDD symptoms will be mediated by changes in BDD-related interpretation bias; and 5) The effects of training in the IBM condition will be maintained at the 3-month follow-up assessments.
- Conditions
- Body Dysmorphic Disorder
- Being tested
- Interpretation Bias Modification, Progressive Muscle Relaxation
- 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.
Interpretation Bias ModificationBehavioural
Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to appearance.
Progressive Muscle RelaxationBehavioural
Eight 15-minute sessions of progressive muscle relaxation (PMR).
| Study group | Role | What they receive |
|---|---|---|
| Interpretation Bias Modification (IBM) | Experimental | Treatment consists of eight brief sessions. In Task 1, participants read unique scenarios ("You notice someone pointing in your direction"). A sentence meant to resolve the ambiguity will appear ("This person thinks they reco_nize you"). After filling in the missing letter, the interpretation is reinforced by requiring the participants to correctly answer "yes" or "no" to a comprehension question ("Is this person mocking you?"). In Task 2, participants are shown a word denoting a threatening ("mocking") or benign ("cheerful") interpretation. Participants are presented with an ambiguous scenario ("You hear people at a nearby table laughing") and asked to denote whether the word and the sentence are related. Participants will receive positive or negative feedback based on their response. Receives: Behavioral: Interpretation Bias Modification |
| Progressive Muscle Relaxation (PMR) | Active comparator | Participants will receive eight brief sessions of PMR. They will listen to a PMR script (Kassinove \& Tafrate, 2002). Participants will be asked to make sure they are sitting comfortably, close their eyes, and systematically tense and release 10 different muscle groups. Receives: Behavioral: Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS; Phillips et al., 1997)
Measures past-week BDD symptom severity
Measured: change from baseline at one-week post treatment and 3-months post-treatment
Secondary outcomes (4)
Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
Measures depressive symptom severity
Measured: change from baseline at one-week post treatment and 3-months post-treatment
Beck Anxiety Inventory (BAI; Steer & Beck, 1997)
Measure anxious symptom severity
Measured: change from baseline at one-week post treatment and 3-months post-treatment
Depressive Symptom Index-Suicidality Subscale
Measure severity of recent suicidality
Measured: change from baseline at one-week post treatment and 3-months post-treatment
Body Dysmorphic Disorder Word Sentence Association Paradigm (BDD-WSAP; modified from Hindash & Amir, 2011)
Measure of strength of BDD-related (i.e. evaluation- and appearance- related threat interpretation biases)
Measured: change from baseline at one-week post treatment and 3-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2018
- Study completionMar 2018
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.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cougle, Florida State University
- Investigators
- Natalie L. Matheny, BA, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635152
- Sponsor's protocol ID
- 2017.20244
- Other IDs
- 2017
- Status last verified
- Jan 2021
- First submitted
- 16 Dec 2015
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Wilver NL, Cougle JR. An Internet-based controlled trial of interpretation bias modification versus progressive muscle relaxation for body dysmorphic disorder. J Consult Clin Psychol. 2019 Mar;87(3):257-269. doi: 10.1037/ccp0000372. Epub 2018 Dec 27.
PubMed 30589349
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Internet-Based Treatment for Body Dysmorphic Disorder
- ClinicalTrials.gov ID
- NCT02635152
- Acronym / sponsor ID
- 2017.20244
- Conditions
- Body Dysmorphic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 18 Dec 2015 (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.
The purpose of this study is to determine whether a computerized intervention designed to reduce appearance and evaluation related interpretation biases will reduce symptoms associated with body dysmorphic disorder.
Detailed description
The present study aims to examine the feasibility of a remote treatment for body dysmorphic disorder delivered via the Internet. To evaluate the efficacy of the IBM protocol we have developed in reducing negative appearance and evaluative related interpretations, we will conduct a two-arm randomized controlled trial over the internet. Individuals with a diagnosis of body dysmorphic disorder (N = 40) will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each condition will consist of eight 10-25 minute treatment sessions. Participants will complete two sessions per week for four weeks and will be administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up. We hypothesize that: 1) IBM will lead to greater reductions in BDD symptoms than the PMR condition; 2) IBM will lead to greater reductions in depression, anxiety and suicidal ideation than the PMR condition; 3) IBM will lead to greater reductions in threat interpretations and greater increases in benign interpretations than the PMR condition; 4) The effects of condition on BDD symptoms will be mediated by changes in BDD-related interpretation bias; and 5) The effects of training in the IBM condition will be maintained at the 3-month follow-up assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpretation Bias Modification (IBM) | Experimental | Behavioral: Interpretation Bias ModificationTreatment consists of eight brief sessions. In Task 1, participants read unique scenarios ("You notice someone pointing in your direction"). A sentence meant to resolve the ambiguity will appear ("This person thinks they reco_nize you"). After filling in the missing letter, the interpretation is reinforced by requiring the participants to correctly answer "yes" or "no" to a comprehension question ("Is this person mocking you?"). In Task 2, participants are shown a word denoting a threatening ("mocking") or benign ("cheerful") interpretation. Participants are presented with an ambiguous scenario ("You hear people at a nearby table laughing") and asked to denote whether the word and the sentence are related. Participants will receive positive or negative feedback based on their response. |
| Progressive Muscle Relaxation (PMR) | Active comparator | Behavioral: Progressive Muscle RelaxationParticipants will receive eight brief sessions of PMR. They will listen to a PMR script (Kassinove \& Tafrate, 2002). Participants will be asked to make sure they are sitting comfortably, close their eyes, and systematically tense and release 10 different muscle groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current diagnosis of Body Dysmorphic Disorder according to DSM-5 criteria
- BDD-YBOCS score greater than or equal to 20
- Fluent in English
- No significant physical defect or flaw in appearance (e.g., disfiguration)
Key exclusion criteria (5 listed)
- History of psychotic disorder, bipolar disorder, borderline personality disorder
- Current substance use disorder
- Unstable medication status (i.e. change in medication within the last month)
- Concurrent psychotherapy for appearance concerns
- Active and clinically significant suicidality
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 |
|---|---|---|
| Interpretation Bias ModificationEight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to appearance. | Behavioural | Interpretation Bias Modification (IBM) |
| Progressive Muscle RelaxationEight 15-minute sessions of progressive muscle relaxation (PMR). | Behavioural | Progressive Muscle Relaxation (PMR) |
Primary outcome
Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS; Phillips et al., 1997)
Time frame: change from baseline at one-week post treatment and 3-months post-treatment
Measures past-week BDD symptom severity
4 secondary outcomes
Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
Time frame: change from baseline at one-week post treatment and 3-months post-treatment
Beck Anxiety Inventory (BAI; Steer & Beck, 1997)
Time frame: change from baseline at one-week post treatment and 3-months post-treatment
Depressive Symptom Index-Suicidality Subscale
Time frame: change from baseline at one-week post treatment and 3-months post-treatment
Body Dysmorphic Disorder Word Sentence Association Paradigm (BDD-WSAP; modified from Hindash & Amir, 2011)
Time frame: change from baseline at one-week post treatment and 3-months post-treatment
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 29 Jan 2021.
- Derived from this study: PubMed 30589349Wilver NL, Cougle JR. An Internet-based controlled trial of interpretation bias modification versus progressive muscle relaxation for body dysmorphic disorder. J Consult Clin Psychol. 2019 Mar;87(3):257-269. doi: 10.1037/ccp0000372. Epub 2018 Dec 27.
- Individual participant dataSharing planned: Undecided
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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.
Natalie L. Matheny, BA principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpretation Bias Modification and Progressive Muscle Relaxation in people with Body Dysmorphic Disorder, run by Florida State University 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 4 inclusion and 5 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 29 Jan 2021. 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?
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?
Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS; Phillips et al., 1997) (time frame: change from baseline at one-week post treatment and 3-months post-treatment). 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 NCT02635152, 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 29 Jan 2021.