Skip to main content
OpenTrials
Completed

NCT Number: NCT01655173

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asperger Syndrome Atypical Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Stockholm psychiatry, St. Göran hospital

Stockholm, SE-11281, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behaviour Therapy

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. Sense of Coherence (SoC, Antonovsky 1993)

    Time frame: At baseline and after 36 sessions (1 calendar year)

    Self-rating scale, change from baseline

  3. 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.

  4. 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.

  5. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Other outcomes

  1. Drop-out

    Time frame: After 36 sessions (1 calendar year)

    How many sessions that each patient attended of the 36 sessions.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Ministry of Health and Social Affairs, Sweden

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Aug 1, 2012
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.