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

Autistic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655173
• Other study ID #: Dnr 52-6104
• Status: Completed
• Phase: N/A
• Start date: August 2005
• Est. completion date: September 2011

Study information

• Verified date: October 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asperger Syndrome
• Atypical Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Northern Stockholm psychiatry, St. Göran hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Ministry of Health and Social Affairs, Sweden

Country where clinical trial is conducted

Sweden, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drop-out	How many sessions that each patient attended of the 36 sessions.	After 36 sessions (1 calendar year)
Primary	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
Primary	Sense of Coherence (SoC, Antonovsky 1993)	Self-rating scale, change from baseline	At baseline and after 36 sessions (1 calendar year)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   PMID: 24089423