Clinical trial NCT05244265: Mindfulness Based Stress Reduction for Intellectually Able Autistic Adults
Official title: Mindfulness Based Stress Reduction (MBSR) for Intellectually Able Autistic Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Treatment Satisfaction
Participation Rate, Patient
Quality of Life
Mental Illness
Acceptance Processes
Stress, Psychological
Keywords: Autism
Adults
Intervention
MBSR
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2022-02-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: First study is an open feasibility study, and the second one is a RCT with two parallel group study arms.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Mindfulness based stress-reduction (MBSR) is a well-known skills training program used worldwide (Kabat-Zinn, 1982), with studies showing positive effects in many different conditions. The MBSR program aims at increased conscious awareness and reduced subjective stress. The intervention includes one physical meeting per week (three hours) over eight weeks' time plus one mindfulness retreat day (six hours). The intervention also incorporates meditations and other suggested tasks for participants to do by themselves in-between the group sessions. The delivery of this particular version of MBSR is adjusted to meet the needs of autistic adults, without the contents of the original MBSR program curriculum being affected. Areas that were adjusted are e.g. group size, physical environment, communication, structure, and homework.

To ensure high treatment fidelity; the MBSR teachers had teacher training following the international standard, as well as being experienced clinicians working at the habilitation services centers, with extensive knowledge about the target group. All MBSR teachers received supervision and tutoring from highly experienced certified MBSR instructor, in order to ensure that the original MBSR program was followed as closely as possible.

The studies were conducted in a clinical outpatient habilitation health care context and thus constitute an important piece in the development of support for adults with ASD. The program will have an effect on facilitating the planning and implementation of feasible and accessible interventions addressing the complex needs of this target group.

This research project consists of two studies; one open feasibility trial and one randomized controlled trial (RCT).

Eligibility criteria: 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.

Primary outcomes:
measure: Study 1 (feasibility study): Treatment completion.
timeFrame: Immediately after intervention.
measure: Study 1 (feasibility study): Credibility as measured by the Treatment Credibility Scale (TCS: Borkovec & Nau, 1972).
timeFrame: Baseline compared to immediately after intervention.
measure: Study 2 (RCT): Perceived stress as measured by the Perceived stress scale (Cohen et al., 1983).
timeFrame: Change from baseline to immediately after the intervention.
Secondary outcomes:
measure: Study 1 (feasibility study): Perceived stress as measured by the Perceived stress scale (Cohen et al., 1983).
timeFrame: Baseline compared to immediately after intervention.
measure: 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).
timeFrame: Baseline compared to immediately after intervention.
measure: Study 1 (feasibility study): Satisfaction with life as measured by Satisfaction with life scale (SWLS: Diener et al., 1985).
timeFrame: Baseline compared to immediately after intervention.
measure: Study 1 (feasibility study): Mindfulness, assessed by Mindful attention awareness scale (MAAS: Brown & Ryan, 2003).
timeFrame: Baseline compared to immediately after intervention.
measure: 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.
timeFrame: Baseline compared to immediately after intervention.
measure: 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).
timeFrame: Change from baseline to immediately after the intervention.
measure: Study 2 (RCT): Life satisfaction as measured by Satisfaction With Life Scale (SWLS: Diener et al., 1985).
timeFrame: Change from baseline to immediately after the intervention.
measure: Study 2 (RCT): Five Facets Mindfulness Questionnaire
timeFrame: Change from baseline to immediately after the intervention.
measure: 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.
timeFrame: Change from baseline to immediately after the intervention.
Other outcomes:
measure: Study 1 (feasibility study and RCT): Adverse events and serious adverse events.
timeFrame: 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.
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