NCT02660099

Brief Summary

The aim of this study is to test the feasibility and acceptability of an internet-delivered cognitive behavior therapy (ICBT) intervention originally developed for neurotypical adolescents with obsessive compulsive disorder (OCD) in adolescents with OCD and autism spectrum disorder (ASD). This feasibility study will inform us how to adapt the original intervention to the specific needs of patients with ASD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

July 7, 2015

Last Update Submit

September 5, 2016

Conditions

Obsessive Compulsive DisorderAutism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • Obsessional Compulsive Inventory - Child version, OCI-CV

    Self-rated OCD symptom levels

    Change from baseline to 12 weeks

Secondary Outcomes (10)

  • Children's Yale Brown Obsessive Compulsive Scale

    Change from baseline to 12 weeks

  • Mini International Neuropsychiatric Interview for Children and Adolescents, MINI-KID

    Baseline

  • Clinical Global Impression - Severity, CGI-S

    Change from baseline to 12 weeks

  • Clinical Global Impression - Improvement, CGI-I

    Post treatment(12 weeks)

  • Children's Global Assessment Scale, CGAS

    Change from baseline to 12 weeks

  • +5 more secondary outcomes

Study Arms (1)

Internet-delivered CBT

EXPERIMENTAL

12 weeks of internet-delivered cognitive behavior therapy provided through a secure internet platform and online clinician contact

Behavioral: Internet-delivered Cognitive Behavior Therapy

Interventions

Internet-delivered Cognitive Behavior TherapyBEHAVIORAL

The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet platform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks. Both parents and adolescents are involved in treatment. Parents will also receive three lectures on 1, Autism spectrum disorder, 2, CBT and functional analysis and 3, Parental strategies

Internet-delivered CBT

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • a diagnosis of OCD as defined by DSM-5 \[40\]
  • a diagnosis of autism defined by DSM-5
  • a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS \[14\]
  • age between 12 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

You may not qualify if:

  • psychosis or bipolar disorder, severe eating disorder
  • 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 another anxiety disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karolinska Institutet

Stockholm, 171 77, Sweden

Location

Karolinska insititute

Stockholm, Sweden

Location

MeSH Terms

Conditions

Obsessive-Compulsive DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersChild Development Disorders, PervasiveNeurodevelopmental Disorders

Study Officials

  • David Mataix-Cols, Professor

    Department of Clinical Neuroscience, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research director

Study Record Dates

First Submitted

July 7, 2015

First Posted

January 21, 2016

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

SE(2)