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Completed

NCT Number: NCT01525576

Booster as an Adjunct to Internet-based Cognitive Behavior Therapy (CBT)

In this trial, we test if adding an Internet-based booster program to regular Internet-based cognitive behavior therapy (ICBT) is effective for patients with obsessive-compulsive disorder (OCD).

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Color Vision Defects Cone Dystrophy Eye Diseases Eye Diseases, Hereditary Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Psykiatri sydväst

Stockholm, Sweden

About this study

Written consent form. Completing ICBT in our previous study: Please see NCT01347099 for more details.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed consent
  • Previously enrolled in our randomized controlled trial testing ICBT for OCD: NCT01347099

Exclusion criteria

  • Suicidal ideation that could jeopardize participation

Treatment and study plan

Booster

Behavioral

3 week booster program + 2 additional weeks two months later for follow-up.

Primary outcomes

  1. Change from Baseline of obsessions and compulsions after 3, 8 and 20 months after baseline.

    Time frame: 3 months before treatment, 3 weeks after treatment starts, 6 and 18 months after treatment has ended

    Yale Brown Obsessive Compulsive Scale (Y-BOCS). Analysis will examine the frequency of relapse from remission between the groups. Furthermore, frequency of incremental cases of remission will be compared between the groups.

Secondary outcomes

  1. Change from Baseline of obsessions and compulsions after 8 and 20 months.

    Time frame: 3 months before treatment, 6 and 18 months after treatment has ended

    Obsessive Compulsive Scale - Revised (OCI-R)

  2. Change from Baseline of obsessions and compulsions after 8 and 20 months.

    Time frame: 3 months before treatment, 6 and 18 months after treatment has ended

    Trimbos Institute Cost-assessment for Psychiatry (TIC-P)

  3. Change from Baseline of obsessions and compulsions after 8 and 20 months.

    Time frame: 3 months before treatment, 6 and 18 months after treatment has ended

    Montgomery Asberg Depression Rating Scale

  4. Change from Baseline of obsessions and compulsions after 8 and 20 months.

    Time frame: 3 months before treatment, 6 and 18 months after treatment has ended

    Euroqol

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Efficacy of an Internet-based Booster Program for Obsessive-compulsive Disorder: A Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 3, 2012
Registry last updated
Jul 31, 2012

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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