Cognitive Behavioural Therapy (CBT) and Recreational Activity for Autism Spectrum Disorders (ASD)
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|ClinicalTrials.gov Identifier: NCT01655173|
Recruitment Status : Completed
First Posted : August 1, 2012
Last Update Posted : June 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Asperger Syndrome Autistic Disorder Atypical Autism||Behavioral: Cognitive behaviour therapy Behavioral: Recreational activity intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Behavioural Therapy and Recreational Activity for Adults With Autism Spectrum Disorders. A Randomized Controlled Trial.|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Experimental: Cognitive behaviour therapy
36 weekly sessions (1 calendar year) of Cognitive behaviour therapy in a group setting.
Behavioral: Cognitive behaviour therapy
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.
Active Comparator: Recreational activity intervention
36 sessions (1 calendar year) of a group intervention to enable social interaction and to break social isolation.
Behavioral: Recreational activity intervention
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.
- 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.
- 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.
- 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
- Autism Quotient (AQ, Baron-Cohen et al. 2001) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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
- Drop-out [ Time Frame: After 36 sessions (1 calendar year) ]How many sessions that each patient attended of the 36 sessions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655173
|Northern Stockholm psychiatry, St. Göran hospital|
|Stockholm, Sweden, SE-11281|
|Principal Investigator:||Susanne Bejerot, MD, PhD||Karolinska Institutet|