NCT02010619

Brief Summary

To evaluate if Internet delivered cognitive behavior therapy is an efficacious treatment when compared to a control group consisting of supportive therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 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

November 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

November 18, 2013

Last Update Submit

August 15, 2017

Conditions

Body Dysmorphic DisorderBDD

Outcome Measures

Primary Outcomes (1)

  • Body Dysmorphic Disorder Modification of the Y-BOCS (BDD-YBOCS)

    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)

    Change in MADRS-S from baseline (week 0) to post-treatment (week 12)

Study Arms (2)

Cognitive behavior therapy

EXPERIMENTAL
Behavioral: Cognitive behavior therapy

Supportive therapy

ACTIVE COMPARATOR
Behavioral: Supportive therapy

Interventions

Cognitive behavior therapyBEHAVIORAL
Cognitive behavior therapy
Supportive therapyBEHAVIORAL
Supportive therapy

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst

Stockholm, Huddinge, 141 86, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 26837684RESULT

  • Flygare 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.

    PMID: 36756354DERIVED

  • Flygare 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.

    PMID: 32429939DERIVED

  • Enander 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.

    PMID: 30647044DERIVED

MeSH Terms

Conditions

Body Dysmorphic Disorders

Interventions

Cognitive Behavioral TherapyPalliative Care

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, M.D.

Study Record Dates

First Submitted

November 18, 2013

First Posted

December 13, 2013

Study Start

November 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations

SE(1)