Internet-based Treatment for Adults With Autism Spectrum Disorder (MILAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03570372|
Recruitment Status : Completed
First Posted : June 27, 2018
Last Update Posted : September 19, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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 raising the quality of life and improving the mental health of 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.
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Internet-based treatment for adults with autism spectrum Behavioral: Psychoeducation about autism spectum disorder||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Internet-based Treatment for Adults With Autism Spectrum Disorder (MILAS)|
|Actual Study Start Date :||August 1, 2018|
|Actual Primary Completion Date :||May 30, 2020|
|Actual Study Completion Date :||May 30, 2020|
Experimental: Intervention group
18 week internet-based CBT with therapist support. Regular online group discussions.
Behavioral: Internet-based treatment for adults with autism spectrum
Internet-based CBT. The intervention includes 18 modules focusing on: Psychoeducation, individual goal setting, behavioral change, management strategies and stress management
Active Comparator: Control group
Reads 2 books about Autism Spectrum Disorder (ASD)
Behavioral: Psychoeducation about autism spectum disorder
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.
- Change in life quality [ Time Frame: Change from Baseline, at 9 weeks, at 18 weeks, at 6 months and at 12 months ]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 in depressive and anxiety symptoms [ Time Frame: Change from Baseline, at 9 weeks, at 18 weeks, at 6 months and at 12 months ]Possible interaction effect between group and time in respect of differences in Depressive and anxiety symptoms of the intervention group and the control group between pre, post and follow-up measurement. Depression and anxiety symptoms will be measured using HADS
- Change in knowledge of ASD [ Time Frame: Change from Baseline, at 9 weeks and at 18 weeks ]Possible interaction effect between group and time in respect of differences in knowledge about ASD of the intervention group and the control group between pre, post and follow-up measurement. Change in knowledge of ASD will be measured using using "Autism Knowledge questionnaire", which is a questionnaire created for the project.
- Subjective experience of ICBT [ Time Frame: At 19 weeks ]The subjective experience of participating in an internet based treatment will be qualitatively evaluated using semi structured interview.
- Content of communication [ Time Frame: At 20 weeks ]Thematic content of the written communication between participant and therapist will be assessed using content analysis.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||16 Years to 55 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Must have ASD diagnosis
- Must have normal IQ
- Must be able to understand and read swedish
- high risk of suicide
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570372
|Region Örebro County|
|Örebro, Örebro County, Sweden, 70217|
|Principal Investigator:||Britta Westerberg||Region Örebro County|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Fredrik Holländare, Doctor of Philosophy, Region Örebro County|
|Other Study ID Numbers:||
|First Posted:||June 27, 2018 Key Record Dates|
|Last Update Posted:||September 19, 2022|
|Last Verified:||September 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Internet based treatment
Autism Spectrum Disorder
Child Development Disorders, Pervasive