- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01655173
Cognitive Behavioural Therapy (CBT) and Recreational Activity for Autism Spectrum Disorders (ASD)
Cognitive Behavioural Therapy and Recreational Activity for Adults With Autism Spectrum Disorders. A Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Stockholm, Sweden, SE-11281
- Northern Stockholm psychiatry, St. Göran hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive behaviour therapy
36 weekly sessions (1 calendar year) of Cognitive behaviour therapy in a group setting.
|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Changes in the Quality of Life Inventory from baseline.
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Baseline, after 36 sessions (1 calendar year) and at a cumulative follow-up within 5 years after treatment termination
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Sense of Coherence (SoC, Antonovsky 1993)
Time Frame: At baseline and after 36 sessions (1 calendar year)
|
Self-rating scale, change from baseline
|
At baseline and after 36 sessions (1 calendar year)
|
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.
|
Before treatment (baseline) and after 36 sessions (1 calendar year)
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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.
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Before treatment and after 36 sessions (1 calendar year)
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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
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Patient rating on a seven-step Likert scale
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Before treatment (at baseline) and at a cumulative follow-up within 5 years after treatment termination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline and after 36 sessions (1 calendar year)
|
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.
|
At baseline and after 36 sessions (1 calendar year)
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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.
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At baseline and after 36 sessions (1 calendar year)
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Symptom Checklist 90 (SCL-90, Derogatis & Cleary 1977)
Time Frame: At baseline and after 36 sessions (1 calendar year)
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This is a 90-item self rating questionnaire assessing the presence and severity of various psychiatric symptoms
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At baseline and after 36 sessions (1 calendar year)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drop-out
Time Frame: After 36 sessions (1 calendar year)
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How many sessions that each patient attended of the 36 sessions.
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After 36 sessions (1 calendar year)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Susanne Bejerot, MD, PhD, Karolinska Institutet
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr 52-6104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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