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

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT02660099
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Internet-delivered Cognitive Behavior Therapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Internet Delivered Cognitive Behavior Therapy for Obsessive-compulsive Disorder in Adolescents With Autism Spectrum Disorder - A Clinical Case Series
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Obsessional Compulsive Inventory - Child version, OCI-CV [Change from baseline to 12 weeks]

    Self-rated OCD symptom levels

Secondary Outcome Measures

  1. Children's Yale Brown Obsessive Compulsive Scale [Change from baseline to 12 weeks]

    Clinician-rated OCD symptom levels

  2. Mini International Neuropsychiatric Interview for Children and Adolescents, MINI-KID [Baseline]

    psychiatric screening of comorbidity

  3. Clinical Global Impression - Severity, CGI-S [Change from baseline to 12 weeks]

    Global symptom levels

  4. Clinical Global Impression - Improvement, CGI-I [Post treatment(12 weeks)]

    Global symptom improvement

  5. Children's Global Assessment Scale, CGAS [Change from baseline to 12 weeks]

    Global level of functioning

  6. Children´s Depression Inventory - Short version [Change from baseline to 12 weeks]

    Symptom level of depressive mood

  7. Strength and difficulties, SDQ [Change from baseline to 12 weeks]

    General psychopathology

  8. Family Accommodation Scale, Parent-Report, FAS-PR [Change from baseline to 12 weeks]

    Parental accommodation to OCD symptoms

  9. Patient ICBT Adherence Rating, PIAR [after 6 weeks and at post treatment(12 weeks)]

    Patient Adherence to internet delivered CBT

  10. Education, Work and Social Adjustment Scale - child and parent version, EWSAS [Change from baseline to 12 weeks]

    Global functioning

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska Institutet Stockholm Sweden 171 77
2 Karolinska insititute Stockholm Sweden

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eva Serlachius, Research director, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02660099
Other Study ID Numbers:
  • BiP-ASD/OCD
First Posted:
Jan 21, 2016
Last Update Posted:
Sep 7, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 7, 2016