Cognitive Behavioural Therapy (CBT) and Recreational Activity for Autism Spectrum Disorders (ASD)
Primary Purpose
Asperger Syndrome, Autistic Disorder, Atypical Autism
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive behaviour therapy
Recreational activity intervention
Sponsored by
About this trial
This is an interventional treatment trial for Asperger Syndrome focused on measuring Asperger syndrome, Autistic disorder, Adult, Psychotherapy
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
Sites / Locations
- Northern Stockholm psychiatry, St. Göran hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive behaviour therapy
Recreational activity intervention
Arm Description
36 weekly sessions (1 calendar year) of Cognitive behaviour therapy in a group setting.
36 sessions (1 calendar year) of a group intervention to enable social interaction and to break social isolation.
Outcomes
Primary Outcome Measures
The Quality of Life Inventory (QOLI, Frisch et al. 1992)
Changes in the Quality of Life Inventory from baseline.
Sense of Coherence (SoC, Antonovsky 1993)
Self-rating scale, change from baseline
The ten-item Rosenberg Self Esteem Scale (RSES, Rosenberg 1962)
This was used to measure self esteem, change from baseline.
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.
Clinical Global Impression scale - Improvement (patient CGI-I)
Patient rating on a seven-step Likert scale
Secondary Outcome Measures
Autism Quotient (AQ, Baron-Cohen et al. 2001)
A 50-item screening instrument for measuring autistic traits. Change from baseline.
Adult ADHD Self-Report Scale (ASRS, Kessler et al. 2005)
This is for self rating scale for measuring inattention, hyperactivity and impulsivity.
Beck Depression Inventory (BDI, Beck et al. 1996)
This is a 20-item questionnaire to assess depression.
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
Full Information
NCT ID
NCT01655173
First Posted
July 25, 2012
Last Updated
October 19, 2020
Sponsor
Karolinska Institutet
Collaborators
Ministry of Health and Social Affairs, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01655173
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Ministry of Health and Social Affairs, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asperger Syndrome, Autistic Disorder, Atypical Autism
Keywords
Asperger syndrome, Autistic disorder, Adult, Psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behaviour therapy
Arm Type
Experimental
Arm Description
36 weekly sessions (1 calendar year) of Cognitive behaviour therapy in a group setting.
Arm Title
Recreational activity intervention
Arm Type
Active Comparator
Arm Description
36 sessions (1 calendar year) of a group intervention to enable social interaction and to break social isolation.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behaviour therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recreational activity intervention
Intervention Description
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 Outcome Measure Information:
Title
The Quality of Life Inventory (QOLI, Frisch et al. 1992)
Description
Changes in the Quality of Life Inventory from baseline.
Time Frame
Baseline, after 36 sessions (1 calendar year) and at a cumulative follow-up within 5 years after treatment termination
Title
Sense of Coherence (SoC, Antonovsky 1993)
Description
Self-rating scale, change from baseline
Time Frame
At baseline and after 36 sessions (1 calendar year)
Title
The ten-item Rosenberg Self Esteem Scale (RSES, Rosenberg 1962)
Description
This was used to measure self esteem, change from baseline.
Time Frame
Before treatment (baseline) and after 36 sessions (1 calendar year)
Title
The patient versions of the Clinical Global Impression scale - Severity (patient CGI-S)
Description
Severity of impairment at baseline rated by the patient. Change from baseline.
Time Frame
Before treatment and after 36 sessions (1 calendar year)
Title
Clinical Global Impression scale - Improvement (patient CGI-I)
Description
Patient rating on a seven-step Likert scale
Time Frame
Before treatment (at baseline) and at a cumulative follow-up within 5 years after treatment termination
Secondary Outcome Measure Information:
Title
Autism Quotient (AQ, Baron-Cohen et al. 2001)
Description
A 50-item screening instrument for measuring autistic traits. Change from baseline.
Time Frame
At baseline and after 36 sessions (1 calendar year)
Title
Adult ADHD Self-Report Scale (ASRS, Kessler et al. 2005)
Description
This is for self rating scale for measuring inattention, hyperactivity and impulsivity.
Time Frame
At baseline and after 36 sessions (1 calendar year)
Title
Beck Depression Inventory (BDI, Beck et al. 1996)
Description
This is a 20-item questionnaire to assess depression.
Time Frame
At baseline and after 36 sessions (1 calendar year)
Title
Symptom Checklist 90 (SCL-90, Derogatis & Cleary 1977)
Description
This is a 90-item self rating questionnaire assessing the presence and severity of various psychiatric symptoms
Time Frame
At baseline and after 36 sessions (1 calendar year)
Other Pre-specified Outcome Measures:
Title
Drop-out
Description
How many sessions that each patient attended of the 36 sessions.
Time Frame
After 36 sessions (1 calendar year)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Bejerot, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Stockholm psychiatry, St. Göran hospital
City
Stockholm
ZIP/Postal Code
SE-11281
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24089423
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.
Results Reference
result
Links:
URL
https://www-ncbi-nlm-nih-gov.proxy.kib.ki.se/pmc/articles/PMC4230566/
Description
PMID: 24089423
Learn more about this trial
Cognitive Behavioural Therapy (CBT) and Recreational Activity for Autism Spectrum Disorders (ASD)
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