An eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder

NCT ID: NCT03473080

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-09
• Study Completion Date: 2021-02-15

Brief Summary

This study is a feasibility study of Internet-delivered CBT for OCD in children and adolescents (7-17 years) with comorbid Autism Spectrum Disorder.

Detailed Description

The main objectives of this study is to evaluate the feasibility, acceptability and preliminary efficacy of internet-delivered Cognitive Behavioral Therapy (ICBT) for Obsessive Compulsive Disorder (OCD) in children and adolescents (7-17 years) with Autism Spectrum Disorders (ASD). The study will an open trial with-in group mean comparison design (n=18). The treatment is delivered over 16 weeks. Study participants will be followed up at 3 (primary endpoint), 6 and 12 months after completed treatment. ICBT is expected to decrease OCD-symptoms.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet CBT

Participants and their parents receive 16 weeks of internet-delivered cognitive behavior therapy (CBT) with psychologist support.

Group Type: OTHER

Internet CBT

Intervention Type: BEHAVIORAL

The treatment consists of a standard cognitive behavior therapy for OCD with additional treatment components to make the treatment better suited for children and adolescents with Autism Spectrum Disorder.

Interventions

Internet CBT

The treatment consists of a standard cognitive behavior therapy for OCD with additional treatment components to make the treatment better suited for children and adolescents with Autism Spectrum Disorder.

Intervention Type: BEHAVIORAL

Other Intervention Names

ICBT; Internet-delivered Cognitive Behavior Therapy

Eligibility Criteria

Inclusion Criteria

• a diagnosis of OCD according to DSM-5
• a diagnosis of autism according to DSM-IV or DSM-5, confirmed with the Autism Diagnostic Interview- Revised or Autism Diagnostic Observation Schedule version 1 or 2 and by medical records
• a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale
• age between 7 and 17 years
• ability to read and write Swedish
• 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

• a diagnosis of psychosis, bipolar disorder, severe eating disorder or intellectual disabilities
• comorbid hoarding disorder or OCD with hoarding as a principal symptom.
• suicidal ideation
• 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 any anxiety disorder
• OCD treatment is not an immediate priority

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Fabian Lenhard

PhD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabian Lenhard, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

BUP OCD and Related Disorders

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

BIP ASD/OCD pilot

Identifier Type: -

Identifier Source: org_study_id