Mindfulness Based Stress Reduction for Intellectually Able Autistic Adults

Mindfulness Based Stress Reduction (MBSR) for Intellectually Able Autistic Adults

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.

Study Overview

• Status: Terminated
• Conditions: Quality of Life; Stress, Psychological; Mental Illness; Acceptance Processes; Treatment Satisfaction; Participation Rate, Patient
• Intervention / Treatment: Behavioral: Mindfulness-based stress reduction (MBSR); Behavioral: Treatment as usual (TAU)

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).

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based stress reduction (MBSR); The 9 session MBSR program following the manual (Kabat-Zinn, 1982).	Behavioral: Mindfulness-based stress reduction (MBSR); The 8 week (plus one-day retreat) manualized MBSR program according to the manual (Kabat-Zinn, 1982).
Active Comparator: Treatment as usual (TAU); Participants take part in their treatment as usual in outpatient habilitation and other services.	Behavioral: Treatment as usual (TAU); Different interventions and support in outpatient and other services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Adults; Autism; Intervention; MBSR
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Mental Disorders
• Other Study ID Numbers: MBSRautisticAdults

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No