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

NCT02191631 | Completed

• 1 other identifier: BiPOCD RCT
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD; adolescents; pediatric; internet; online; CBT

Outcome Measures

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

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

Secondary Outcomes (11)

• Clinical Global Impression - Severity, CGI-S

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

• Clinical Global Impression - Improvement, CGI-I

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

• Parent Adherence EX/RP Scale, PEAS

  Baseline, 6 and 12 weeks after treatment starts

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

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

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

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

Other Outcomes (3)

• Measurement of homework adherence

  Baseline, daily measurements until 12 weeks after baseline

• Number of Participants with Adverse Events

  12 weeks after baseline

• DNA samples (from blood and/or saliva)

  Baseline

Study Arms (2)

Internet-delivered CBT

EXPERIMENTAL

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

Behavioral: Internet-delivered Cognitive Behavior Therapy

Wait list

NO INTERVENTION

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

Interventions

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.

Internet-delivered CBT

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, 171 77, Sweden

Location

Related Publications (2)

• 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.

  PMID: 28515196 DERIVED

• 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.

  PMID: 27993223 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Eva Serlachius, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 16, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

SE (1)