Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder

Not Applicable

Completed

• Conditions: Obsessive-compulsive Disorder
• Interventions: Behavioral: Cognitive-behavioral therapy (face-to-face); Behavioral: Internet-based Cognitive-behavioral therapy without therapist support; Behavioral: Internet-based Cognitive-behavioral therapy

• Registration Number: NCT02541968
• Lead Sponsor: Karolinska Institutet

Brief Summary

Randomized controlled non-inferiority trial comparing therapist-guided Internet-based Cognitive behavioral therapy (ICBT), self-guided ICBT, and individual face-to-face (f2f) CBT for Obsessive-Compulsive Disorder (OCD) in adults.

The primary objective is to evaluate whether ICBT is a non-inferior treatment option compared to the best possible available treatment for OCD, individual face to face (f2f) CBT. A second objective is to compare the efficacy of self-guided vs. therapist-guided ICBT. As this question has cost implications for the health system, a third objective is to carry out a health economic evaluation of both forms of ICBT, in relation to the gold standard f2f CBT. A fourth objective is to explore whether ICBT is equally suited for clinic-referred cases compared to self-referred patients. Finally, a fifth objective is to investigate whether genetic markers, in combination with clinical variables, can be employed to predict treatment outcomes with CBT in general.

Research Questions:

Q1: Is therapist-guided internet-based CBT (ICBT) for OCD non-inferior to face-to-face (f2f) CBT with regard to OCD symptoms, function and quality of life?

Q2: Is entirely self-guided ICBT non-inferior to f2f CBT with regard to OCD symptoms, function and quality of life?

Q3: Is ICBT a cost-effective treatment, compared to f2f CBT?

Q4: Is there a difference in treatment outcome between self-referred and clinical referred patients?

Q5: Can clinical variables and genetic markers be useful to predict which patients will benefit from CBT?

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-09-01
• Study Start: 2015-09-03
• Study First Posted: 2015-09-04
• Primary Completion: 2019-05
• Study Completion: 2021-01-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• ≥ 18 years of age,
• Internet access,
• primary diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5),
• Written consent of participation in the study.

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Exclusion Criteria

• Other psychological treatment for OCD during the treatment period,
• Adjustment of concurrent psychotropic medication within the last two months,
• bipolar disorder,
• psychosis,
• alcohol or substance dependence,
• completed CBT for OCD in the last 12 months,
• hoarding disorder or OCD with primary hoarding symptoms,
• suicidal ideation,
• subjects that lack the ability to read written Swedish or lack the cognitive ability to assimilate to the written material,
• Autism spectrum disorder,
• organic brain disorder.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Face-to-face CBT	Cognitive-behavioral therapy (face-to-face)	16 sessions of individual CBT delivered in 14 weeks.
ICBT without therapist support	Internet-based Cognitive-behavioral therapy without therapist support	Internet-based CBT without therapist support (14 weeks).
Internet-based CBT	Internet-based Cognitive-behavioral therapy	Internet-based CBT (ICBT) with therapist support (14 weeks).

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)	Change from baseline to treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.

Secondary Outcome Measures

Name	Time	Method
Structured Clinical Interview for DSM-5 (SCID-5) obsessive-compulsive and related disorders Structured Clinical Interview for DSM-5 (SCID-5) obsessive-compulsive and related disorders	Change from baseline to treatmentweek 15, 3- and 12-month follow-up.	Diagnostic status
Obsessive-Compulsive Inventory - Revised (OCI-R)	Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Clinical Global Impression - Improvement (CGI-I)	Treatmentweek 15, 3- and 12-month follow-up.
TiC-P	Treatmentweek 0, 15, 3- and 12-month follow-up.	Self-rated questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder
Working Alliance Inventory - short revised	Change from baseline to treatment week 6 and 15
Yale-Brown Obsessive-Compulsive Scale - self-rated (Y-BOCS)	Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Sheehan Disability Scale (SDS)	Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Clinical Global Impression - Severity (CGI-S)	Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Montgomery-Åsberg Depression Rating Scale - self-rated (MADRS-S)	Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Insomnia Severity Index (ISI)	Treatmentweek 15, 3- and 12-month follow-up.
Treatment credibility scale	Change from baseline to treatmentweek 2.
Global Assessment of Functioning (GAF)	Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Euroqol (EQ-5D)	Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Patient EX/RP Adherence Scale (PEAS)	Treatmentweek 6 and 15
Satisfaction with treatment scale	Treatmentweek 15
Safety Monitoring Uniform Report Form (SMURF)	Treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.

Trial Locations

Locations (1)

Mottagningen för Tvångssyndrom; 🇸🇪 Huddinge, Sweden