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NCT Number: NCT02191631

Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study

The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17 years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment condition.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, 171 77, Sweden

About this study

The primary objective of this study is to test the efficacy of Internet-delivered cognitive behavior therapy (ICBT) for adolescents (12 - 17 years) with OCD. We aim to conduct a randomized controlled study with N = 66 participants. Participants will be randomly assigned to ICBT or a wait list condition, either lasting 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 and 12 months after treatment. ICBT is expected to yield significantly better symptom reduction than the wait list condition.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • a primary diagnosis of OCD as defined by DSM-5
  • a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS
  • age between 12 and 17 years
  • ability to read and write Swedish
  • daily access to the internet
  • a parent that is able to co-participate in the treatment
  • Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion criteria

  • diagnosed autism spectrum disorder, psychosis or bipolar disorder, severe eating disorder
  • suicidal ideation
  • ongoing substance dependence
  • subject not able to read or understand the basics of the ICBT material
  • completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention)
  • ongoing psychological treatment for OCD or another anxiety disorder

Treatment and study plan

Internet-delivered Cognitive Behavior Therapy

Behavioral

The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet plattform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks.

Primary outcomes

  1. Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS

    Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

    Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 12 months after treatment

Secondary outcomes

  1. Clinical Global Impression - Severity, CGI-S

    Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

  2. Clinical Global Impression - Improvement, CGI-I

    Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

  3. Parent Adherence EX/RP Scale, PEAS

    Time frame: Baseline, 6 and 12 weeks after treatment starts

  4. Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003)

    Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

  5. Education, Work and Social Adjustment Scale - child and parent version (EWSAS)

    Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

  6. Spence Child Anxiety Scale - Child and Parent version (SCAS-C/P, Spence, 1998

    Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

  7. Child Depression Inventory - Short version (CDI-S, Kovacs, 1985)

    Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

  8. Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009)

    Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

  9. Technology acceptance scale

    Time frame: Baseline, 6 and 12 weeks after treatment starts,

  10. Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)

    Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

  11. EQ-5D - quality of life

    Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Other outcomes

  1. Measurement of homework adherence

    Time frame: Baseline, daily measurements until 12 weeks after baseline

  2. Number of Participants with Adverse Events

    Time frame: 12 weeks after baseline

  3. DNA samples (from blood and/or saliva)

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Study

Acronym: BiPOCD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 16, 2014
Registry last updated
Dec 22, 2016

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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