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

Primary Purpose

Obsessive Compulsive Disorder, Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered Cognitive Behavior Therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Karolinska Institutet
  • Karolinska insititute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internet-delivered CBT

Arm Description

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

Outcomes

Primary Outcome Measures

Obsessional Compulsive Inventory - Child version, OCI-CV
Self-rated OCD symptom levels

Secondary Outcome Measures

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

Full Information

First Posted
July 7, 2015
Last Updated
September 5, 2016
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02660099
Brief Title
Internet Delivered CBT for OCD in Adolescents With ASD - A Clinical Case Series
Official Title
Internet Delivered Cognitive Behavior Therapy for Obsessive-compulsive Disorder in Adolescents With Autism Spectrum Disorder - A Clinical Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder, Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-delivered CBT
Arm Type
Experimental
Arm Description
12 weeks of internet-delivered cognitive behavior therapy provided through a secure internet platform and online clinician contact
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered Cognitive Behavior Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Obsessional Compulsive Inventory - Child version, OCI-CV
Description
Self-rated OCD symptom levels
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Children's Yale Brown Obsessive Compulsive Scale
Description
Clinician-rated OCD symptom levels
Time Frame
Change from baseline to 12 weeks
Title
Mini International Neuropsychiatric Interview for Children and Adolescents, MINI-KID
Description
psychiatric screening of comorbidity
Time Frame
Baseline
Title
Clinical Global Impression - Severity, CGI-S
Description
Global symptom levels
Time Frame
Change from baseline to 12 weeks
Title
Clinical Global Impression - Improvement, CGI-I
Description
Global symptom improvement
Time Frame
Post treatment(12 weeks)
Title
Children's Global Assessment Scale, CGAS
Description
Global level of functioning
Time Frame
Change from baseline to 12 weeks
Title
Children´s Depression Inventory - Short version
Description
Symptom level of depressive mood
Time Frame
Change from baseline to 12 weeks
Title
Strength and difficulties, SDQ
Description
General psychopathology
Time Frame
Change from baseline to 12 weeks
Title
Family Accommodation Scale, Parent-Report, FAS-PR
Description
Parental accommodation to OCD symptoms
Time Frame
Change from baseline to 12 weeks
Title
Patient ICBT Adherence Rating, PIAR
Description
Patient Adherence to internet delivered CBT
Time Frame
after 6 weeks and at post treatment(12 weeks)
Title
Education, Work and Social Adjustment Scale - child and parent version, EWSAS
Description
Global functioning
Time Frame
Change from baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mataix-Cols, Professor
Organizational Affiliation
Department of Clinical Neuroscience, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
171 77
Country
Sweden
Facility Name
Karolinska insititute
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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