Body Dysmorhpic DisorderNCT01850433
Internet Cognitive Behavior Therapy (CBT) for Body Dysmorphic Disorder (BDD)
A study testing Internet based CBT for body dysmorphic disorder in people with Body Dysmorhpic Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The primary aim is to develop, and test the feasibility, of a novel and protocol-based cognitive behaviour therapy (CBT) treatment for body dysmorphic disorder (BDD) administered via the Internet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Dysmorhpic Disorder
- What is being tested?
- Internet based CBT for body dysmorphic disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2013to Mar 2014
- 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
- outpatients
- male or female
- -≥ 18 years
- currently living in Stockholm county
- primary diagnosis of BDD according to the DSM-IV-TR
- signed informed consent
- 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
- BDD-YBOCS < 12 at psychiatrist visit
- other primary axis I diagnosis
- current substance dependence
- lifetime bipolar disorder or psychosis
Show all 9Show fewer
- suicidal ideation
- Axis II diagnosis that could jeopardize treatment participation
- other current psychological treatment that could affect BDD symptoms
Trial locations and contacts
1 site in 1 country.
Sweden1 site
M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom
Stockholm, 141 86
About this study
Official title: Internet-based Cognitive Behavior Therapy for Body Dysmorphic Disorder: A Pilot Study
The primary aim is to develop, and test the feasibility, of a novel and protocol-based cognitive behaviour therapy (CBT) treatment for body dysmorphic disorder (BDD) administered via the Internet.
- Conditions
- Body Dysmorhpic Disorder
- Being tested
- Internet based CBT for body dysmorphic disorder
- Keywords
- BDD, CBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet based CBT for body dysmorphic disorderBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Internet CBT | Experimental | Not described Receives: Behavioral: Internet based CBT for body dysmorphic disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body dysmorphic disorder symptoms
Measured: Measured after 12 weeks of treatment, and after 3 months after treatment
Secondary outcomes (2)
Functioning and life satisfaction
Measured: After 12 weeks of treatment, and 3 months after treatment
Depressive symptoms
Measured: After 12 weeks of treatment, and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionMar 2014
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 Dysmorhpic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Rück, Karolinska Institutet
- Investigators
- Christian Rück, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850433
- Sponsor's protocol ID
- BDD-P
- Status last verified
- Aug 2017
- First submitted
- 7 May 2013
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Enander J, Ivanov VZ, Andersson E, Mataix-Cols D, Ljotsson B, Ruck C. Therapist-guided, Internet-based cognitive-behavioural therapy for body dysmorphic disorder (BDD-NET): a feasibility study. BMJ Open. 2014 Sep 25;4(9):e005923. doi: 10.1136/bmjopen-2014-005923.
PubMed 25256187
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-based Cognitive Behavior Therapy for Body Dysmorphic Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT01850433
- Acronym / sponsor ID
- BDD-P
- Conditions
- Body Dysmorhpic Disorder
- Keywords
- BDD, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 May 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.
The primary aim is to develop, and test the feasibility, of a novel and protocol-based cognitive behaviour therapy (CBT) treatment for body dysmorphic disorder (BDD) administered via the Internet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet CBT | Experimental | Behavioral: Internet based CBT for body dysmorphic disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- outpatients
- male or female
- -≥ 18 years
- currently living in Stockholm county
- primary diagnosis of BDD according to the DSM-IV-TR
Key exclusion criteria (9 listed)
- psychotropic medication changes within two months prior to the treatment
- completed CBT for BDD within the last 12 months
- BDD-YBOCS < 12 at psychiatrist visit
- other primary axis I diagnosis
- current substance dependence
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 |
|---|---|---|
| Internet based CBT for body dysmorphic disorder | Behavioural | Internet CBT |
Primary outcome
Body dysmorphic disorder symptoms
Time frame: Measured after 12 weeks of treatment, and after 3 months after treatment
2 secondary outcomes
Functioning and life satisfaction
Time frame: After 12 weeks of treatment, and 3 months after treatment
Depressive symptoms
Time frame: After 12 weeks of treatment, and 3 months after 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 18 Aug 2017.
- Results publication: PubMed 25256187Enander J, Ivanov VZ, Andersson E, Mataix-Cols D, Ljotsson B, Ruck C. Therapist-guided, Internet-based cognitive-behavioural therapy for body dysmorphic disorder (BDD-NET): a feasibility study. BMJ Open. 2014 Sep 25;4(9):e005923. doi: 10.1136/bmjopen-2014-005923.
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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.
Christian Rück, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet based CBT for body dysmorphic disorder in people with Body Dysmorhpic Disorder, 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 7 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 symptoms (time frame: Measured after 12 weeks of treatment, and after 3 months after 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 NCT01850433, 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 18 Aug 2017.