Autism Spectrum Disorder Clinical Trial
— MILASOfficial title:
Internet-based Treatment for Adults With Autism Spectrum Disorder (MILAS)
NCT number | NCT03570372 |
Other study ID # | 17RS4920 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2018 |
Est. completion date | May 30, 2020 |
Verified date | September 2023 |
Source | Örebro County Council |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | May 30, 2020 |
Est. primary completion date | May 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 55 Years |
Eligibility | Inclusion Criteria: - Must have ASD diagnosis - Must have normal IQ - Must be able to understand and read swedish Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Region Örebro County | Örebro | Örebro County |
Lead Sponsor | Collaborator |
---|---|
Örebro County Council | Örebro University, Sweden |
Sweden,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Change in depressive and anxiety symptoms | 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 from Baseline, at 9 weeks, at 18 weeks, at 6 months and at 12 months | |
Secondary | Subjective experience of ICBT | The subjective experience of participating in an internet based treatment will be qualitatively evaluated using semi structured interview. | At 19 weeks | |
Secondary | Content of communication | Thematic content of the written communication between participant and therapist will be assessed using content analysis. | At 20 weeks |
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