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Clinical Trials/NCT01655173
NCT01655173
Completed
N/A

Cognitive Behavioural Therapy and Recreational Activity for Adults With Autism Spectrum Disorders. A Randomized Controlled Trial.

Karolinska Institutet1 site in 1 country68 target enrollmentAugust 2005

Overview

Phase
N/A
Intervention
Not specified
Conditions
Asperger Syndrome
Sponsor
Karolinska Institutet
Enrollment
68
Locations
1
Primary Endpoint
The Quality of Life Inventory (QOLI, Frisch et al. 1992)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2005
End Date
September 2011
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susanne Bejerot

Associate professor

Karolinska Institutet

Eligibility Criteria

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

Outcomes

Primary Outcomes

The Quality of Life Inventory (QOLI, Frisch et al. 1992)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: Before treatment and after 36 sessions (1 calendar year)

Severity of impairment at baseline rated by the patient. Change from baseline.

Secondary Outcomes

  • Autism Quotient (AQ, Baron-Cohen et al. 2001)(At baseline and after 36 sessions (1 calendar year))
  • Adult ADHD Self-Report Scale (ASRS, Kessler et al. 2005)(At baseline and after 36 sessions (1 calendar year))
  • Beck Depression Inventory (BDI, Beck et al. 1996)(At baseline and after 36 sessions (1 calendar year))
  • Symptom Checklist 90 (SCL-90, Derogatis & Cleary 1977)(At baseline and after 36 sessions (1 calendar year))

Study Sites (1)

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