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Completed

NCT Number: NCT02541968

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

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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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mottagningen för Tvångssyndrom

Huddinge, 14186, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive-behavioral therapy (face-to-face)

Behavioral

Other names: CBT

Internet-based Cognitive-behavioral therapy

Behavioral

With therapist support

Other names: ICBT

Internet-based Cognitive-behavioral therapy without therapist support

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Sep 4, 2015
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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