Asperger SyndromeNCT01655173
Cognitive Behavioural Therapy (CBT) and Recreational Activity for Autism Spectrum Disorders (ASD)
A study testing Cognitive behaviour therapy and Recreational activity intervention in people with Asperger Syndrome and Autistic Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asperger Syndrome, Autistic Disorder, Atypical Autism
- What is being tested?
- Cognitive behaviour therapy and Recreational activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2005to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Current substance abuse
- Current psychosis
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Northern Stockholm psychiatry, St. Göran hospital
Stockholm, SE-11281
About this study
Official title: Cognitive Behavioural Therapy and Recreational Activity for Adults With Autism Spectrum Disorders. A Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Asperger Syndrome, Autistic Disorder, Atypical Autism
- Being tested
- Cognitive behaviour therapy, Recreational activity intervention
- Keywords
- Asperger syndrome, Autistic disorder, Adult, Psychotherapy
- Medical subject headings
- Asperger Syndrome, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behaviour therapyBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behaviour therapy | Experimental | 36 weekly sessions (1 calendar year) of Cognitive behaviour therapy in a group setting. Receives: Behavioral: Cognitive behaviour therapy |
| Recreational activity intervention | Active comparator | 36 sessions (1 calendar year) of a group intervention to enable social interaction and to break social isolation. Receives: Behavioral: Recreational activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quality of Life Inventory (QOLI, Frisch et al. 1992)
Changes in the Quality of Life Inventory from baseline.
Measured: Baseline, after 36 sessions (1 calendar year) and at a cumulative follow-up within 5 years after treatment termination
Sense of Coherence (SoC, Antonovsky 1993)
Self-rating scale, change from baseline
Measured: At baseline and after 36 sessions (1 calendar year)
The ten-item Rosenberg Self Esteem Scale (RSES, Rosenberg 1962)
This was used to measure self esteem, change from baseline.
Measured: Before treatment (baseline) and after 36 sessions (1 calendar year)
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.
Measured: Before treatment and after 36 sessions (1 calendar year)
Clinical Global Impression scale - Improvement (patient CGI-I)
Patient rating on a seven-step Likert scale
Measured: Before treatment (at baseline) and at a cumulative follow-up within 5 years after treatment termination
Secondary outcomes (4)
Autism Quotient (AQ, Baron-Cohen et al. 2001)
A 50-item screening instrument for measuring autistic traits. Change from baseline.
Measured: At baseline and after 36 sessions (1 calendar year)
Adult ADHD Self-Report Scale (ASRS, Kessler et al. 2005)
This is for self rating scale for measuring inattention, hyperactivity and impulsivity.
Measured: At baseline and after 36 sessions (1 calendar year)
Beck Depression Inventory (BDI, Beck et al. 1996)
This is a 20-item questionnaire to assess depression.
Measured: At baseline and after 36 sessions (1 calendar year)
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
Measured: At baseline and after 36 sessions (1 calendar year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startAug 2005
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asperger SyndromeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Social Affairs, Sweden
- Responsible party
- Principal investigator, Susanne Bejerot, Karolinska Institutet
- Investigators
- Susanne Bejerot, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655173
- Sponsor's protocol ID
- Dnr 52-6104
- Status last verified
- Oct 2020
- First submitted
- 25 Jul 2012
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24089423
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy and Recreational Activity for Adults With Autism Spectrum Disorders. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01655173
- Acronym / sponsor ID
- Dnr 52-6104
- Conditions
- Asperger Syndrome, Autistic Disorder, Atypical Autism
- Keywords
- Asperger syndrome, Autistic disorder, Adult, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Ministry of Health and Social Affairs, Sweden
- Study start
- Aug 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behaviour therapy | Experimental | Behavioral: Cognitive behaviour therapy36 weekly sessions (1 calendar year) of Cognitive behaviour therapy in a group setting. |
| Recreational activity intervention | Active comparator | Behavioral: Recreational activity intervention36 sessions (1 calendar year) of a group intervention to enable social interaction and to break social isolation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Current substance abuse
- Current psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behaviour therapyThe 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. | Behavioural | Cognitive behaviour therapy |
| Recreational activity interventionThe 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. | Behavioural | Recreational activity intervention |
Primary outcome
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.
Sense of Coherence (SoC, Antonovsky 1993)
Time frame: At baseline and after 36 sessions (1 calendar year)
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)
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)
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
Patient rating on a seven-step Likert scale
4 secondary outcomes
Autism Quotient (AQ, Baron-Cohen et al. 2001)
Time frame: 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)
Beck Depression Inventory (BDI, Beck et al. 1996)
Time frame: At baseline and after 36 sessions (1 calendar year)
Symptom Checklist 90 (SCL-90, Derogatis & Cleary 1977)
Time frame: At baseline and after 36 sessions (1 calendar year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Results publication: PubMed 24089423Hesselmark 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.
- PMID: 24089423Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Bejerot, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behaviour therapy and Recreational activity intervention in people with Asperger Syndrome and Autistic Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01655173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.