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

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ClinicalTrials.gov Identifier: NCT02541968
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Christian Rück, Karolinska Institutet

Study Description
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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?


Condition or disease Intervention/treatment Phase
Obsessive-compulsive Disorder Behavioral: Cognitive-behavioral therapy (face-to-face) Behavioral: Internet-based Cognitive-behavioral therapy Behavioral: Internet-based Cognitive-behavioral therapy without therapist support Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder - a Randomized Controlled Non-inferiority Trial
Actual Study Start Date : September 3, 2015
Actual Primary Completion Date : May 2019
Actual Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: CBT
Experimental: Internet-based CBT
Internet-based CBT (ICBT) with therapist support (14 weeks).
 Behavioral: Internet-based Cognitive-behavioral therapy
With therapist support
Other Name: ICBT
Experimental: ICBT without therapist support
Internet-based CBT without therapist support (14 weeks).
 Behavioral: Internet-based Cognitive-behavioral therapy without therapist support


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Clinical Global Impression - Severity (CGI-S) [ Time Frame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up. ]
  2. Global Assessment of Functioning (GAF) [ Time Frame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up. ]
  3. 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

  4. Yale-Brown Obsessive-Compulsive Scale - self-rated (Y-BOCS) [ Time Frame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up. ]
  5. Obsessive-Compulsive Inventory - Revised (OCI-R) [ Time Frame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up. ]
  6. Sheehan Disability Scale (SDS) [ Time Frame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up. ]
  7. Montgomery-Åsberg Depression Rating Scale - self-rated (MADRS-S) [ Time Frame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up. ]
  8. Euroqol (EQ-5D) [ Time Frame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up. ]
  9. Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Treatmentweek 15, 3- and 12-month follow-up. ]
  10. Insomnia Severity Index (ISI) [ Time Frame: Treatmentweek 15, 3- and 12-month follow-up. ]
  11. Treatment credibility scale [ Time Frame: Change from baseline to treatmentweek 2. ]
  12. Satisfaction with treatment scale [ Time Frame: Treatmentweek 15 ]
  13. 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

  14. Safety Monitoring Uniform Report Form (SMURF) [ Time Frame: Treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up. ]
  15. Patient EX/RP Adherence Scale (PEAS) [ Time Frame: Treatmentweek 6 and 15 ]
  16. Working Alliance Inventory - short revised [ Time Frame: Change from baseline to treatment week 6 and 15 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541968


Locations
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Sweden
Mottagningen för Tvångssyndrom
Huddinge, Sweden, 14186
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Christian Rück Karolinska Institutet
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christian Rück, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02541968    
Other Study ID Numbers: OCD F2F vs ICBT
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders