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CompletedNCT02191631BiPOCDUpdated Dec 22, 2016

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

An interventional study of Internet-delivered Cognitive Behavior Therapy in Obsessive-Compulsive Disorder, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-12-22.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Obsessive-Compulsive Disorder

Keywords

  • OCD
  • adolescents
  • pediatric
  • internet
  • online
  • CBT
03

In context

Compulsive Personality Disorder

367 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.

This study's enrollment of 67 is above the median of 37 across 306 interventional studies indexed under Compulsive Personality Disorder.

Browse Compulsive Personality Disorder studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    Internet-delivered CBT

    Participants will receive 12 weeks of internet-delivered cognitive behavior therapy with psychologist support.

    Behavioral: Internet-delivered Cognitive Behavior Therapy

  • No intervention
    Wait list

    Participants will receive no treatment for 12 weeks. After that period participants will receive Internet-delivered Cognitive Behavior Therapy.

Interventions

  • BehavioralInternet-delivered Cognitive Behavior Therapy

    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.

06

What researchers measure

Primary outcomes

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

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

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

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

07

Study locations

1 site
  • Karolinska Institutet
    Stockholm, 171 77, Sweden
08

References and documents

Publications

  • Lenhard F, Ssegonja R, Andersson E, Feldman I, Ruck C, Mataix-Cols D, Serlachius E. Cost-effectiveness of therapist-guided internet-delivered cognitive behaviour therapy for paediatric obsessive-compulsive disorder: results from a randomised controlled trial. BMJ Open. 2017 May 17;7(5):e015246. doi: 10.1136/bmjopen-2016-015246. Erratum In: BMJ Open. 2017 Jun 21;7(6):e015246corr1. doi: 10.1136/bmjopen-2016-015246corr1. PubMed 28515196 ↗
  • Lenhard F, Andersson E, Mataix-Cols D, Ruck C, Vigerland S, Hogstrom J, Hillborg M, Brander G, Ljungstrom M, Ljotsson B, Serlachius E. Therapist-Guided, Internet-Delivered Cognitive-Behavioral Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2017 Jan;56(1):10-19.e2. doi: 10.1016/j.jaac.2016.09.515. Epub 2016 Oct 25. PubMed 27993223 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02191631
Lead sponsor
Karolinska Institutet
Responsible party
Eva Serlachius (MD, PhD, Karolinska Institutet) — Principal investigator
First posted
Jul 16, 2014
Start date
Aug 2014
Primary completion
Mar 2016
Completion
Dec 2016
Last update
Dec 22, 2016

Study contacts

Eva Serlachius, MD, PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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