Clinical trial NCT01655173: Cognitive Behavioural Therapy (CBT) and Recreational Activity for Autism Spectrum Disorders (ASD)
Official title: Cognitive Behavioural Therapy and Recreational Activity for Adults With Autism Spectrum Disorders. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asperger Syndrome
Autistic Disorder
Atypical Autism
Keywords: Asperger syndrome
Autistic disorder
Adult
Psychotherapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Social Affairs, Sweden
First posted: 2012-08-01
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Quality of Life Inventory (QOLI, Frisch et al. 1992)
timeFrame: Baseline, after 36 sessions (1 calendar year) and at a cumulative follow-up within 5 years after treatment termination
measure: Sense of Coherence (SoC, Antonovsky 1993)
timeFrame: At baseline and after 36 sessions (1 calendar year)
measure: The ten-item Rosenberg Self Esteem Scale (RSES, Rosenberg 1962)
timeFrame: Before treatment (baseline) and after 36 sessions (1 calendar year)
measure: The patient versions of the Clinical Global Impression scale - Severity (patient CGI-S)
timeFrame: Before treatment and after 36 sessions (1 calendar year)
measure: Clinical Global Impression scale - Improvement (patient CGI-I)
timeFrame: Before treatment (at baseline) and at a cumulative follow-up within 5 years after treatment termination
Secondary outcomes:
measure: Autism Quotient (AQ, Baron-Cohen et al. 2001)
timeFrame: At baseline and after 36 sessions (1 calendar year)
measure: Adult ADHD Self-Report Scale (ASRS, Kessler et al. 2005)
timeFrame: At baseline and after 36 sessions (1 calendar year)
measure: Beck Depression Inventory (BDI, Beck et al. 1996)
timeFrame: At baseline and after 36 sessions (1 calendar year)
measure: Symptom Checklist 90 (SCL-90, Derogatis & Cleary 1977)
timeFrame: At baseline and after 36 sessions (1 calendar year)
Other outcomes:
measure: Drop-out
timeFrame: After 36 sessions (1 calendar year)
Locations:
city: Stockholm
country: Sweden
facility: Northern Stockholm psychiatry, St. Göran hospital
Study officials:
affiliation: Karolinska Institutet
name: Susanne Bejerot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.