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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-03

Study Completion Date

2021-01-31

Brief Summary

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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?

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Detailed Description

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Conditions

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Obsessive-compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Face-to-face CBT

16 sessions of individual CBT delivered in 14 weeks.

Group Type ACTIVE_COMPARATOR

Cognitive-behavioral therapy (face-to-face)

Intervention Type BEHAVIORAL

Internet-based CBT

Internet-based CBT (ICBT) with therapist support (14 weeks).

Group Type EXPERIMENTAL

Internet-based Cognitive-behavioral therapy

Intervention Type BEHAVIORAL

With therapist support

ICBT without therapist support

Internet-based CBT without therapist support (14 weeks).

Group Type EXPERIMENTAL

Internet-based Cognitive-behavioral therapy without therapist support

Intervention Type BEHAVIORAL

Interventions

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Cognitive-behavioral therapy (face-to-face)

Intervention Type BEHAVIORAL

Internet-based Cognitive-behavioral therapy

With therapist support

Intervention Type BEHAVIORAL

Internet-based Cognitive-behavioral therapy without therapist support

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT ICBT

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No