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

This study has been completed.
Sponsor:
Collaborator:
The Swedish National Board of Health and Welfare
Information provided by (Responsible Party):
Susanne Bejerot, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01655173
First received: July 25, 2012
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Asperger Syndrome
Autistic Disorder
Atypical Autism
Behavioral: Cognitive behaviour therapy
Behavioral: Recreational activity intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Behavioural Therapy and Recreational Activity for Adults With Autism Spectrum Disorders. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patient rating on a seven-step Likert scale


Secondary Outcome Measures:
  • Autism Quotient (AQ, Baron-Cohen et al. 2001) [ Time Frame: At baseline and after 36 sessions (1 calendar year) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    This is a 90-item self rating questionnaire assessing the presence and severity of various psychiatric symptoms


Other Outcome Measures:
  • Drop-out [ Time Frame: After 36 sessions (1 calendar year) ] [ Designated as safety issue: No ]
    How many sessions that each patient attended of the 36 sessions.


Enrollment: 68
Study Start Date: August 2005
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655173

Locations
Sweden
Northern Stockholm psychiatry, St. Göran hospital
Stockholm, Sweden, SE-11281
Sponsors and Collaborators
Karolinska Institutet
The Swedish National Board of Health and Welfare
Investigators
Principal Investigator: Susanne Bejerot, MD, PhD Karolinska Institutet
  More Information

Publications:
Responsible Party: Susanne Bejerot, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01655173     History of Changes
Other Study ID Numbers: Dnr 52-6104
Study First Received: July 25, 2012
Last Updated: June 17, 2014
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Karolinska Institutet:
Asperger syndrome
Autistic disorder
Adult
Psychotherapy

Additional relevant MeSH terms:
Asperger Syndrome
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Syndrome
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014