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

Karolinska Institute

Status: Completed

Conditions: Obsessive-compulsive Disorder

Treatments: Behavioral: Cognitive-behavioral therapy (face-to-face); Behavioral: Internet-based Cognitive-behavioral therapy without therapist support; Behavioral: Internet-based Cognitive-behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02541968

OCD F2F vs ICBT

Details and patient eligibility

About

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?

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Face-to-face CBT

Active Comparator group

Description:

16 sessions of individual CBT delivered in 14 weeks.

Treatment:

Behavioral: Cognitive-behavioral therapy (face-to-face)

Internet-based CBT

Experimental group

Description:

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

Treatment:

Behavioral: Internet-based Cognitive-behavioral therapy

ICBT without therapist support

Experimental group

Description:

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

Treatment:

Behavioral: Internet-based Cognitive-behavioral therapy without therapist support