Internet-based Treatment for Adults With Autism Spectrum Disorder (iALMA) (iALMA)
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|ClinicalTrials.gov Identifier: NCT03570372|
Recruitment Status : Not yet recruiting
First Posted : June 27, 2018
Last Update Posted : June 27, 2018
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 and symptoms of depression and anxiety. Participants in the intervention group receives a 37 session 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||Early Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Internet-based Treatment for Adults With Autism Spectrum Disorder (iALMA)|
|Estimated Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||May 30, 2020|
|Estimated Study Completion Date :||May 30, 2020|
Experimental: Intervention group
36 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 36 modules focusing on: Psychoeducation, individual goal setting, behavioral change, management strategies, mindfulness techniques, stress management, sleep techniques, information about societal rights.
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.
- Correlation between schizotypal traits using SPQ and effect in quality of Life using BBQ [ Time Frame: Correlation are measured from Baseline, at 9 weeks and at 18 weeks ]Potential correlation between schizotypal traits using the questionnaire Schizotypal traits questionnaire (SPQ) and effect in quality of Life using Brunnsviken Brief Quality of life questionnaire (BBQ)
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
|Contact: Britta Westerberg, Psychologistemail@example.com|
|Contact: Fredrik Holländare, Med. firstname.lastname@example.org|
|Region Örebro County||Not yet recruiting|
|Örebro, Örebro County, Sweden, 70217|
|Contact: Britta Westerberg +46767672800 email@example.com|
|Principal Investigator:||Britta Westerberg||Region Örebro County|