NCT01655173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

6.1 years

First QC Date

July 25, 2012

Last Update Submit

October 19, 2020

Conditions

Keywords

Asperger syndromeAutistic disorderAdultPsychotherapy

Outcome Measures

Primary Outcomes (5)

  • The Quality of Life Inventory (QOLI, Frisch et al. 1992)

    Changes in the Quality of Life Inventory from baseline.

    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

    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.

    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.

    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

    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)

    At baseline and after 36 sessions (1 calendar year)

  • Adult ADHD Self-Report Scale (ASRS, Kessler et al. 2005)

    At baseline and after 36 sessions (1 calendar year)

  • Beck Depression Inventory (BDI, Beck et al. 1996)

    At baseline and after 36 sessions (1 calendar year)

  • Symptom Checklist 90 (SCL-90, Derogatis & Cleary 1977)

    At baseline and after 36 sessions (1 calendar year)

Other Outcomes (1)

  • Drop-out

    After 36 sessions (1 calendar year)

Study Arms (2)

Cognitive behaviour therapy

EXPERIMENTAL

36 weekly sessions (1 calendar year) of Cognitive behaviour therapy in a group setting.

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.

Behavioral: Recreational activity intervention

Interventions

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.

Cognitive behaviour therapy

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.

Recreational activity intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Current substance abuse
  • Current psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Stockholm psychiatry, St. Göran hospital

Stockholm, SE-11281, Sweden

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Asperger SyndromeAutistic Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Susanne Bejerot, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 25, 2012

First Posted

August 1, 2012

Study Start

August 1, 2005

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations