Mindfulness Based Stress Reduction for Intellectually Able Autistic Adults

NCT ID: NCT05244265

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2021-09-01

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).

Conditions

Treatment Satisfaction; Participation Rate, Patient; Quality of Life; Mental Illness; Acceptance Processes; Stress, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Mindfulness-based stress reduction (MBSR)

The 9 session MBSR program following the manual (Kabat-Zinn, 1982).

Group Type: EXPERIMENTAL

Mindfulness-based stress reduction (MBSR)

Intervention Type: BEHAVIORAL

The 8 week (plus one-day retreat) manualized MBSR program according to the manual (Kabat-Zinn, 1982).

Treatment as usual (TAU)

Participants take part in their treatment as usual in outpatient habilitation and other services.

Group Type: ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

Different interventions and support in outpatient and other services.

Interventions

Mindfulness-based stress reduction (MBSR)

The 8 week (plus one-day retreat) manualized MBSR program according to the manual (Kabat-Zinn, 1982).

Intervention Type: BEHAVIORAL

Treatment as usual (TAU)

Different interventions and support in outpatient and other services.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Tatja Hirvikoski

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MBSRautisticAdults

Identifier Type: -

Identifier Source: org_study_id