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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Asperger Syndrome, Autistic Disorder, Atypical Autism

Intervention / Treatment
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* Behavioral: Cognitive behaviour therapy
* Behavioral: Recreational activity intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behaviour therapy<br>36 weekly sessions (1 calendar year) of Cognitive behaviour therapy in a group setting. | Behavioral: Cognitive behaviour therapy<br>* The CBT intervention consisted of five elements: (a) structure, (b) group setting, (c) psycho-education, (d) social training and (e) CBT. The participants were presented with the session plan for the whole year and given a binder in which they kept all materials. In addition, each session followed a strict agenda: (1) introduction and presentation of the agenda of the day, (2) resume of homework assignments from the previous session, (3) psycho-educative lecture and discussions on the session topic, (4) coffee break with buns or sandwiches, and social interaction, (5) relaxation or mindfulness exercise, (6) discussions and exercises on the session topic, (7) distribution of homework and (8) evaluation and end of session.<br>|
| Active Comparator: Recreational activity intervention<br>36 sessions (1 calendar year) of a group intervention to enable social interaction and to break social isolation. | Behavioral: Recreational activity intervention<br>* The therapists did not provide any deliberate interventions, such as psychoeducation, social training or CBT. Instead, the intervention relied on structure and group setting only. During the first session the participants were asked to write down group activities they would like to engage in. The therapists created a list of the suggested activities, such as visiting museums, board game playing, cooking, restaurant visits, boating, cinema and taking walks. The participants voted for the activity of the next session.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asperger syndrome, Autistic disorder, Adult, Psychotherapy