NCT01850433

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

May 7, 2013

Last Update Submit

August 15, 2017

Conditions

Keywords

BDDCBT

Outcome Measures

Primary Outcomes (1)

  • Body dysmorphic disorder symptoms

    Measured after 12 weeks of treatment, and after 3 months after treatment

Secondary Outcomes (2)

  • Functioning and life satisfaction

    After 12 weeks of treatment, and 3 months after treatment

  • Depressive symptoms

    After 12 weeks of treatment, and 3 months after treatment

Study Arms (1)

Internet CBT

EXPERIMENTAL
Behavioral: Internet based CBT for body dysmorphic disorder

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • suicidal ideation
  • Axis II diagnosis that could jeopardize treatment participation
  • other current psychological treatment that could affect BDD symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M46 Huddinge sjukhus, Internetpsykiatrienheten/mottagningen för tvångssyndrom

Stockholm, 141 86, Sweden

Location

Related Publications (1)

  • 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.

Related Links

Study Officials

  • Christian Rück, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, M.D.

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 9, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations