Body Dysmorphic DisorderNCT02010619
Internet Delivered CBT for Body Dysmorphic Disorder
A study testing Cognitive behavior therapy and Supportive therapy in people with Body Dysmorphic Disorder and BDD, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
To evaluate if Internet delivered cognitive behavior therapy is an efficacious treatment when compared to a control group consisting of supportive therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Dysmorphic Disorder, BDD
- What is being tested?
- Cognitive behavior therapy and Supportive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2013to Jan 2015
- 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
- outpatient
- ≥ 18 years
- primary diagnosis of BDD according to the DSM-5
- BDD-YBOCS ≥20
- regular access to a computer with Internet access and skills to use the web.
Who cannot join
- psychotropic medication changes within two months prior to the treatment,
- completed CBT for BDD within the last 12 months,
- other primary axis I diagnosis
- current substance dependence
- lifetime bipolar disorder or psychosis
- suicidal ideation
Show all 9Show fewer
- Axis II diagnosis that could jeopardize treatment participation,
- other current psychological treatment that could affect BDD symptoms
- A serious medical illness that precludes participation in the study
Trial locations and contacts
1 site in 1 country.
Sweden1 site
M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst
Stockholm, Huddinge, 141 86
About this study
Official title: Internet Delivered Cognitive Behavior Therapy for Body Dysmorphic Disorder - a Randomized Controlled Trial
To evaluate if Internet delivered cognitive behavior therapy is an efficacious treatment when compared to a control group consisting of supportive therapy.
- Conditions
- Body Dysmorphic Disorder, BDD
- Being tested
- Cognitive behavior therapy, Supportive therapy
- 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.
Cognitive behavior therapyBehavioural
Supportive therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavior therapy | Experimental | Not described Receives: Behavioral: Cognitive behavior therapy |
| Supportive therapy | Active comparator | Not described Receives: Behavioral: Supportive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Dysmorphic Disorder Modification of the Y-BOCS (BDD-YBOCS)
Measured: Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 12)
Secondary outcomes (1)
The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)
Measured: Change in MADRS-S from baseline (week 0) to post-treatment (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Karolinska InstitutetThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Rück, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010619
- Sponsor's protocol ID
- BDD RCT
- Status last verified
- Aug 2017
- First submitted
- 18 Nov 2013
- Last updated
- 18 Aug 2017
- Results posted
- No
Publications
Enander J, Andersson E, Mataix-Cols D, Lichtenstein L, Alstrom K, Andersson G, Ljotsson B, Ruck C. Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial. BMJ. 2016 Feb 2;352:i241. doi: 10.1136/bmj.i241.
PubMed 26837684Flygare O, Andersson E, Glimsdal G, Mataix-Cols D, Pascal D, Ruck C, Enander J. Cost-effectiveness of internet-delivered cognitive behaviour therapy for body dysmorphic disorder: Results from a randomised controlled trial. Internet Interv. 2023 Jan 24;31:100604. doi: 10.1016/j.invent.2023.100604. eCollection 2023 Mar.
PubMed 36756354Flygare O, Enander J, Andersson E, Ljotsson B, Ivanov VZ, Mataix-Cols D, Ruck C. Predictors of remission from body dysmorphic disorder after internet-delivered cognitive behavior therapy: a machine learning approach. BMC Psychiatry. 2020 May 19;20(1):247. doi: 10.1186/s12888-020-02655-4.
PubMed 32429939Enander J, Ljotsson B, Anderhell L, Runeborg M, Flygare O, Cottman O, Andersson E, Dahlen S, Lichtenstein L, Ivanov VZ, Mataix-Cols D, Ruck C. Long-term outcome of therapist-guided internet-based cognitive behavioural therapy for body dysmorphic disorder (BDD-NET): a naturalistic 2-year follow-up after a randomised controlled trial. BMJ Open. 2019 Jan 15;9(1):e024307. doi: 10.1136/bmjopen-2018-024307.
PubMed 30647044
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Delivered Cognitive Behavior Therapy for Body Dysmorphic Disorder - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02010619
- Acronym / sponsor ID
- BDD RCT
- Conditions
- Body Dysmorphic Disorder, BDD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 Dec 2013 (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.
To evaluate if Internet delivered cognitive behavior therapy is an efficacious treatment when compared to a control group consisting of supportive therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavior therapy | Experimental | Behavioral: Cognitive behavior therapy |
| Supportive therapy | Active comparator | Behavioral: Supportive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- outpatient
- ≥ 18 years
- primary diagnosis of BDD according to the DSM-5
- BDD-YBOCS ≥20
- regular access to a computer with Internet access and skills to use the web.
Key exclusion criteria (9 listed)
- psychotropic medication changes within two months prior to the treatment,
- completed CBT for BDD within the last 12 months,
- other primary axis I diagnosis
- 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 |
|---|---|---|
| Cognitive behavior therapy | Behavioural | Cognitive behavior therapy |
| Supportive therapy | Behavioural | Supportive therapy |
Primary outcome
Body Dysmorphic Disorder Modification of the Y-BOCS (BDD-YBOCS)
Time frame: Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 12)
1 secondary outcome
The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)
Time frame: Change in MADRS-S from baseline (week 0) to post-treatment (week 12)
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 18 Aug 2017.
- Results publication: PubMed 26837684Enander J, Andersson E, Mataix-Cols D, Lichtenstein L, Alstrom K, Andersson G, Ljotsson B, Ruck C. Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial. BMJ. 2016 Feb 2;352:i241. doi: 10.1136/bmj.i241.
- Derived from this study: PubMed 36756354Flygare O, Andersson E, Glimsdal G, Mataix-Cols D, Pascal D, Ruck C, Enander J. Cost-effectiveness of internet-delivered cognitive behaviour therapy for body dysmorphic disorder: Results from a randomised controlled trial. Internet Interv. 2023 Jan 24;31:100604. doi: 10.1016/j.invent.2023.100604. eCollection 2023 Mar.
- Derived from this study: PubMed 32429939Flygare O, Enander J, Andersson E, Ljotsson B, Ivanov VZ, Mataix-Cols D, Ruck C. Predictors of remission from body dysmorphic disorder after internet-delivered cognitive behavior therapy: a machine learning approach. BMC Psychiatry. 2020 May 19;20(1):247. doi: 10.1186/s12888-020-02655-4.
- Derived from this study: PubMed 30647044Enander J, Ljotsson B, Anderhell L, Runeborg M, Flygare O, Cottman O, Andersson E, Dahlen S, Lichtenstein L, Ivanov VZ, Mataix-Cols D, Ruck C. Long-term outcome of therapist-guided internet-based cognitive behavioural therapy for body dysmorphic disorder (BDD-NET): a naturalistic 2-year follow-up after a randomised controlled trial. BMJ Open. 2019 Jan 15;9(1):e024307. doi: 10.1136/bmjopen-2018-024307.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior therapy and Supportive therapy in people with Body Dysmorphic Disorder and BDD, run by Karolinska Institutet at 1 site in Sweden.
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 9 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 18 Aug 2017. 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 Sweden. 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 Modification of the Y-BOCS (BDD-YBOCS) (time frame: Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 12)). 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 NCT02010619, which also lists 4 linked publications.
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 18 Aug 2017.