Quality of Life Clinical Trial
Official title:
Mindfulness Based Stress Reduction (MBSR) for Intellectually Able Autistic Adults
Verified date | February 2022 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project evaluates mindfulness based stress-reduction (MBSR), adjusted and manualized for intellectually able autistic adults. MBSR is a skills training program based on further development of cognitive behavioral therapy. The program includes eight weekly group training sessions and one full-day retreat, aiming at stress reduction and improved coping in everyday life, as well as improved mental health. The aspiration is to make ASD-adjusted MBSR an intervention that is acceptable and accessible to individuals with autism in open clinical care. This includes considering variability in background factors such as age, comorbidity and other personal qualities and preferences. The aim of the studies is to evaluate (1) the feasibility and (2) effectiveness of MBSR in adults (18 or over) with autism without intellectual disability, in an outpatient clinical habilitation context.
Status | Terminated |
Enrollment | 140 |
Est. completion date | September 1, 2021 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnose within the autism spectrum according to ICD-10, DSM-IV or DSM-5. - Minimum =18 years of age. - Adequate knowledge of the Swedish language. Exclusion Criteria: - Intellectual disability (IQ=70). - Severe mental illnesses that would hinder participation (e.g. psychosis or acute risk for suicidal behaviors). - Drug use in the last three months. - Poor mental health as assessed with Montgomary Åsberg Depression Rating Scale (MADRS) in combination with semi-structured interview by a clinical psychologist. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Karolinska Institutet | Region Stockholm |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Study 1 (feasibility study and RCT): Adverse events and serious adverse events. | Events reported by participants that occured during intervention (up to 9 weeks) and may or may not be associated with participation in the intervention. | At any timepoint during or immediately after the intervention, i.e. not a measure that was assessed for all participants, but reported by any participant that felt he/she had experienced an adverse event. | |
Primary | Study 1 (feasibility study): Treatment completion. | Participants attending six or more out of the total nine occasions (eight sessions and one retreat) (=66%) were considered completers. | Immediately after intervention. | |
Primary | Study 1 (feasibility study): Credibility as measured by the Treatment Credibility Scale (TCS: Borkovec & Nau, 1972). | Five statements scored on a ten-point Likert scale where higher points indicate higher treatment credibility. | Baseline compared to immediately after intervention. | |
Primary | Study 2 (RCT): Perceived stress as measured by the Perceived stress scale (Cohen et al., 1983). | 14 statements scored on a five-point Likert-scale (0-4) where higher points indicate higher perceived stress. | Change from baseline to immediately after the intervention. | |
Secondary | Study 1 (feasibility study): Perceived stress as measured by the Perceived stress scale (Cohen et al., 1983). | 14 statements scored on a five-point Likert-scale (0-4) where higher points indicate higher perceived stress. | Baseline compared to immediately after intervention. | |
Secondary | Study 1 (feasibility study): Symptoms of anxiety and depression as measured by Hospital anxiety and depression scale (HADS: the Swedish Lisspers et al., 1997; Zigmond & Snaith, 1983). | 14 statements scored on a four-point Likert scale from "not at all" to "very often", where higher points indicate more anxiety and depressive symptoms. In addition, sub-scales anxiety and depression were analyzed separately. | Baseline compared to immediately after intervention. | |
Secondary | Study 1 (feasibility study): Satisfaction with life as measured by Satisfaction with life scale (SWLS: Diener et al., 1985). | Five statements scored on a seven-point Likert-scale (1-7) where higher points indicate more satisfaction with life. | Baseline compared to immediately after intervention. | |
Secondary | Study 1 (feasibility study): Mindfulness, assessed by Mindful attention awareness scale (MAAS: Brown & Ryan, 2003). | 15 statements and scored on a six-point Likert-scale (1-6), where higher scores indicate elevated mindful awareness. | Baseline compared to immediately after intervention. | |
Secondary | Study 1 (feasibility study): Acceptance of the Autism diagnosis, assessed by a modified version of the Acceptance and action questionnaire (Bond et al., 2011) for ASD. | Seven statements and scored on a seven-point Likert-scale , where higher points indicate less acceptance of the ASD diagnosis. | Baseline compared to immediately after intervention. | |
Secondary | Study 2 (RCT): Symptoms of anxiety and depression as measured by Hospital anxiety and depression scale (HADS: the Swedish Lisspers et al., 1997; Zigmond & Snaith, 1983). | 14 statements scored on a four-point Likert scale from "not at all" to "very often", where higher points indicate more anxiety and depressive symptoms. In addition, sub-scales anxiety and depression were analyzed separately. | Change from baseline to immediately after the intervention. | |
Secondary | Study 2 (RCT): Life satisfaction as measured by Satisfaction With Life Scale (SWLS: Diener et al., 1985). | Five statements scored on a seven-point (1-7) Likert-scale, where higher points indicate more satisfaction with life. | Change from baseline to immediately after the intervention. | |
Secondary | Study 2 (RCT): Five Facets Mindfulness Questionnaire | 29 statements scored on a five-point (1-5) Likert-scale (Baer et. al., 2006). Higher points indicate higher mindful awareness. | Change from baseline to immediately after the intervention. | |
Secondary | Study 2 (RCT): Acceptance of the autism diagnosis, assessed by a modified version of the Acceptance and Action Questionnaire (AAQ: Bond et al., 2011) for ASD. | Seven statements scored on a seven-point (1-7) Likert-scale, where higher points indicate less acceptance of the ASD diagnosis. | Change from baseline to immediately after the intervention. |
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