Internet Delivered CBT for OCD in Adolescents With ASD - A Clinical Case Series

Internet Delivered Cognitive Behavior Therapy for Obsessive-compulsive Disorder in Adolescents With Autism Spectrum Disorder - A Clinical Case Series

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.

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder; Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Internet-delivered Cognitive Behavior Therapy

Detailed Description

To evaluate the effectiveness of ICBT for OCD in adolescents with ASD, this study will use a single case experimental design with weekly measures during two phases: A-B. The A-phase will consist of baseline measures at least three weeks prior to treatment. The B-phase will consist of the 12 weeks ICBT-program as well as one measure post-treatment. Single case descriptions of each participant will be presented. Weekly measures on the Obsessional Compulsive Inventory - Child version (OCI-CV) will be analyzed through visual inspection of each participants graph and through computation of Percentage of Non-overlapping Data (PND). PND is a frequently used effect measure in SCED and reflects how large percentage of the measurements during the treatment-phase that do not overlap with any of the measurements during the base-line phase.

To assess the feasibility and comprehension of the ICBT treatment semi-structured interviews (face-to-face or telephone) will be conducted with participants and parents weekly during the four first weeks of ICBT and semi-weekly during the rest of the treatment. Detailed notes will be taken during each interview and will serve as content material for a thematic analysis trying to determine possible accommodations to the ICBT protocol to better suit patients with ASD.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 171 77
    • Karolinska Institutet
  • Stockholm, Sweden
    • Karolinska insititute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Internet-delivered CBT; 12 weeks of internet-delivered cognitive behavior therapy provided through a secure internet platform and online clinician contact

Behavioral: Internet-delivered Cognitive Behavior Therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obsessional Compulsive Inventory - Child version, OCI-CV	Self-rated OCD symptom levels	Change from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Yale Brown Obsessive Compulsive Scale	Clinician-rated OCD symptom levels	Change from baseline to 12 weeks
Mini International Neuropsychiatric Interview for Children and Adolescents, MINI-KID	psychiatric screening of comorbidity	Baseline
Clinical Global Impression - Severity, CGI-S	Global symptom levels	Change from baseline to 12 weeks
Clinical Global Impression - Improvement, CGI-I	Global symptom improvement	Post treatment(12 weeks)
Children's Global Assessment Scale, CGAS	Global level of functioning	Change from baseline to 12 weeks
Children´s Depression Inventory - Short version	Symptom level of depressive mood	Change from baseline to 12 weeks
Strength and difficulties, SDQ	General psychopathology	Change from baseline to 12 weeks
Family Accommodation Scale, Parent-Report, FAS-PR	Parental accommodation to OCD symptoms	Change from baseline to 12 weeks
Patient ICBT Adherence Rating, PIAR	Patient Adherence to internet delivered CBT	after 6 weeks and at post treatment(12 weeks)
Education, Work and Social Adjustment Scale - child and parent version, EWSAS	Global functioning	Change from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: David Mataix-Cols, Professor, Department of Clinical Neuroscience, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: July 7, 2015
• First Submitted That Met QC Criteria: January 18, 2016
• First Posted (ESTIMATE): January 21, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 5, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: BiP-ASD/OCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED