Cognitive Behavioural Therapy (CBT) and Recreational Activity for Autism Spectrum Disorders (ASD)

Not Applicable

Completed

• Conditions: Atypical Autism; Asperger Syndrome; Autistic Disorder
• Interventions: Behavioral: Cognitive behaviour therapy; Behavioral: Recreational activity intervention

• Registration Number: NCT01655173
• Lead Sponsor: Karolinska Institutet

Brief Summary

The purpose of this study is to determine if adults with autism spectrum disorder and with normal intelligence improve from 36 sessions (1 calendar year) of group treatment with Cognitive Behavioural Therapy or recreational activity in groups with 6-8 participants.

Detailed Description

The purpose of this study was to compare two group interventions for psychiatric patients with Autism spectrum disorder and normal intelligence: Cognitive Behavioural Therapy developed to suit adults with Autism spectrum disorder, and recreational activity, enabling social interaction. The recreational activity intervention served as a low-impact option, easily organised within the community. It is not a placebo; rather it controls for the positive effects that come out of a structured social environment and group setting. The investigators hypothesized that both interventions would lead to improvement in quality of life, well-being and relief in psychiatric symptoms, with a greater effect in the Cognitive Behavioural Therapy intervention compared to recreational activity. A cumulative follow-up was made, within 5 1/2 years after the start of the treatments. Additional questions adapted to the patient group were added at this 5 1/2 year time point.

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-07-31
• Study First Posted: 2012-08-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Clinical diagnosis of autism spectrum disorders
• Normal intelligence as assumed by mainstream schooling
• Acceptance of a group setting
• Being able to transport themselves to the clinic (with or without support)

Exclusion Criteria

• Current substance abuse
• Current psychosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behaviour therapy	Cognitive behaviour therapy	36 weekly sessions (1 calendar year) of Cognitive behaviour therapy in a group setting.
Recreational activity intervention	Recreational activity intervention	36 sessions (1 calendar year) of a group intervention to enable social interaction and to break social isolation.

Primary Outcome Measures

Name	Time	Method
The Quality of Life Inventory (QOLI, Frisch et al. 1992)	Baseline, after 36 sessions (1 calendar year) and at a cumulative follow-up within 5 years after treatment termination	Changes in the Quality of Life Inventory from baseline.
Clinical Global Impression scale - Improvement (patient CGI-I)	Before treatment (at baseline) and at a cumulative follow-up within 5 years after treatment termination	Patient rating on a seven-step Likert scale
Sense of Coherence (SoC, Antonovsky 1993)	At baseline and after 36 sessions (1 calendar year)	Self-rating scale, change from baseline
The ten-item Rosenberg Self Esteem Scale (RSES, Rosenberg 1962)	Before treatment (baseline) and after 36 sessions (1 calendar year)	This was used to measure self esteem, change from baseline.
The patient versions of the Clinical Global Impression scale - Severity (patient CGI-S)	Before treatment and after 36 sessions (1 calendar year)	Severity of impairment at baseline rated by the patient. Change from baseline.

Secondary Outcome Measures

Name	Time	Method
Autism Quotient (AQ, Baron-Cohen et al. 2001)	At baseline and after 36 sessions (1 calendar year)	A 50-item screening instrument for measuring autistic traits. Change from baseline.
Adult ADHD Self-Report Scale (ASRS, Kessler et al. 2005)	At baseline and after 36 sessions (1 calendar year)	This is for self rating scale for measuring inattention, hyperactivity and impulsivity.
Beck Depression Inventory (BDI, Beck et al. 1996)	At baseline and after 36 sessions (1 calendar year)	This is a 20-item questionnaire to assess depression.
Symptom Checklist 90 (SCL-90, Derogatis & Cleary 1977)	At baseline and after 36 sessions (1 calendar year)	This is a 90-item self rating questionnaire assessing the presence and severity of various psychiatric symptoms

Trial Locations

Locations (1)

Northern Stockholm psychiatry, St. Göran hospital; 🇸🇪 Stockholm, Sweden