NCT03570372

Brief Summary

The group of patients diagnosed with Autism spectrum disorder (ASD) is increasing and so is the need for new and effective treatment methods. ASD is characterized, among other things, by difficulties in social interaction and communication. These difficulties often affects their quality of life and causes a risk of developing social anxiety or other forms of mental illness, which often leads to isolation and may cause difficulties in participating in regular face- to- face psychological treatment. Although research shows that group therapy is favorable for this group of patients, many with ASD refrain from group-treatment due to social anxiety or difficulties with public transport. In order to increase the availability of evidence based psychological treatment for these patients, it seems important to be able to offer a web-based treatment option, with the ability to participate in online group sessions. The aim of the study is to investigate whether Internet-based CBT is an effective method of improving the quality of life and sense of coherence and decreasing symtoms of anxiety and depression among adults with ASD. A randomized controlled study design will be used. Assessment will be conducted through video interviews, recruiting 84 patients with ASD and normal intellectual abilities. Symptoms of depression and other forms of psychopathology will be assessed through MINI-7 interviews. Primary outcome measures are quality of life. Participants in the intervention group receives a 18 week blended treatment combining individual ICBT delivered through a treatment platform called Stöd och Behandling (SOB) with the opportunity to participate in regular group discussions delivered through a discussion forum online. Participants in the control groups are offered self-studies through psycho educative books about ASD. Data will be collected at baseline, mid-treatment, post-treatment and after six and 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration 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

First Submitted

Initial submission to the registry

January 29, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

January 29, 2018

Last Update Submit

April 2, 2025

Conditions

Keywords

Life qualityASDInternet based treatmentAutismICBT

Outcome Measures

Primary Outcomes (2)

  • Change in life quality

    Possible interaction effect between group and time in respect of differences in quality of life of the intervention group and the control group between pre, post and follow-up measurement

    Change from Baseline, at 9 weeks, at 18 weeks, at 6 months and at 12 months

  • Change in Sense of coherence

    Possible interaction effect between group and time in respect of differences in Sense of coherence of the intervention group and the control group between pre, post and follow-up measurement. Sense of coherence will be measured using SOC-13 questionnaire.

    Change from Baseline, at 18 weeks, at 6 months and at 12 months

Secondary Outcomes (3)

  • Change in depressive and anxiety symptoms

    Change from Baseline, at 9 weeks, at 18 weeks, at 6 months and at 12 months

  • Subjective experience of ICBT

    At 19 weeks

  • Content of communication

    At 20 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

18 week internet-based CBT with therapist support. Regular online group discussions.

Behavioral: Internet-based treatment for adults with autism spectrum

Control group

ACTIVE COMPARATOR

Reads 2 books about Autism Spectrum Disorder (ASD)

Behavioral: Psychoeducation about autism spectum disorder

Interventions

Internet-based CBT. The intervention includes 18 modules focusing on: Psychoeducation, individual goal setting, behavioral change, management strategies and stress management

Intervention group

Self-studies by reading the book "What does the disability mean ?: Living with autism / Asperger syndrome. Project Empowerment "(2004), by Norrö \& Swing Åström, as well as a book of biographical stories of people who have ASD. The first book will be read during the first half of the project, and the second will be in the second half.

Control group

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Must have ASD diagnosis
  • Must have normal IQ
  • Must be able to understand and read swedish

You may not qualify if:

  • high risk of suicide
  • psychosis
  • inability to fill out forms and answer questions on the internet
  • inability to read and understand the Swedish language
  • ongoing psychotherapy with CBT or social behavior training
  • mental development disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Örebro County

Örebro, Örebro County, 70217, Sweden

Location

Related Publications (27)

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    PMID: 22466510BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    PMID: 10245370BACKGROUND
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    PMID: 11556941BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    PMID: 24089423BACKGROUND
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    BACKGROUND
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    PMID: 8039356BACKGROUND
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  • Andersen LM, Naswall K, Manouilenko I, Nylander L, Edgar J, Ritvo RA, Ritvo E, Bejerot S. The Swedish version of the Ritvo autism and asperger diagnostic scale: revised (RAADS-R). A validation study of a rating scale for adults. J Autism Dev Disord. 2011 Dec;41(12):1635-45. doi: 10.1007/s10803-011-1191-3.

    PMID: 21327833BACKGROUND
  • Westerberg B, Jacobson K, Unenge Hallerback M, Bejerot S, Hollandare F. Communicative Behaviors in an Internet-Based Intervention for Individuals With Autism: Mixed Methods Analysis. J Med Internet Res. 2026 Feb 4;28:e76527. doi: 10.2196/76527.

  • Klang A, Westerberg B, Humble MB, Bejerot S. The impact of schizotypy on quality of life among adults with autism spectrum disorder. BMC Psychiatry. 2022 Mar 19;22(1):205. doi: 10.1186/s12888-022-03841-2.

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Britta Westerberg

    Region Örebro County

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Philosophy

Study Record Dates

First Submitted

January 29, 2018

First Posted

June 27, 2018

Study Start

August 1, 2018

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations