Cognitive Behavioural Therapy (CBT) and Recreational Activity for Autism Spectrum Disorders (ASD)
1 other identifier
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 25, 2012
CompletedFirst Posted
Study publicly available on registry
August 1, 2012
CompletedOctober 22, 2020
October 1, 2020
6.1 years
July 25, 2012
October 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (4)
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)
Other Outcomes (1)
Drop-out
After 36 sessions (1 calendar year)
Study Arms (2)
Cognitive behaviour therapy
EXPERIMENTAL36 weekly sessions (1 calendar year) of Cognitive behaviour therapy in a group setting.
Recreational activity intervention
ACTIVE COMPARATOR36 sessions (1 calendar year) of a group intervention to enable social interaction and to break social isolation.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Current substance abuse
- Current psychosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northern Stockholm psychiatry, St. Göran hospital
Stockholm, SE-11281, Sweden
Related Publications (1)
Hesselmark E, Plenty S, Bejerot S. Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: a preliminary randomized controlled trial. Autism. 2014 Aug;18(6):672-83. doi: 10.1177/1362361313493681. Epub 2013 Oct 2.
PMID: 24089423RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susanne Bejerot, MD, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
July 25, 2012
First Posted
August 1, 2012
Study Start
August 1, 2005
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
October 22, 2020
Record last verified: 2020-10