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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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