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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02010619
Other study ID # BDD RCT
Secondary ID
Status Completed
Phase N/A
First received November 18, 2013
Last updated August 15, 2017
Start date November 2013
Est. completion date January 2015

Study information

Verified date August 2017
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design


Intervention

Behavioral:
Cognitive behavior therapy

Supportive therapy


Locations

Country Name City State
Sweden M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm Huddinge

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Enander J, Andersson E, Mataix-Cols D, Lichtenstein L, Alström K, Andersson G, Ljótsson B, Rück C. Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial. BMJ. 2016 Feb 2;352:i2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Body Dysmorphic Disorder Modification of the Y-BOCS (BDD-YBOCS) Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 12)
Secondary The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S) Change in MADRS-S from baseline (week 0) to post-treatment (week 12)
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