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

April 14, 2022 updated by: Christian Rück, Karolinska Institutet

Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder - a Randomized Controlled Non-inferiority Trial

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Huddinge, Sweden, 14186
        • Mottagningen för Tvångssyndrom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Face-to-face CBT
16 sessions of individual CBT delivered in 14 weeks.
Behavioral: Cognitive-behavioral therapy (face-to-face)
Other Names:
  • CBT
Experimental: Internet-based CBT
Internet-based CBT (ICBT) with therapist support (14 weeks).
Behavioral: Internet-based Cognitive-behavioral therapy
With therapist support
Other Names:
  • ICBT
Experimental: ICBT without therapist support
Internet-based CBT without therapist support (14 weeks).
Behavioral: Internet-based Cognitive-behavioral therapy without therapist support

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Christian Rück, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2015

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

August 24, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCD F2F vs ICBT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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