Mindfulness Based Stress Reduction for Intellectually Able Autistic Adults

NCT05244265 | Terminated

• 1 other identifier: MBSRautisticAdults
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Autism; Adults; Intervention; MBSR

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Study 1 (feasibility study): Perceived stress as measured by the Perceived stress scale (Cohen et al., 1983).

  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).

  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).

  Baseline compared to immediately after intervention.

• Study 1 (feasibility study): Mindfulness, assessed by Mindful attention awareness scale (MAAS: Brown & Ryan, 2003).

  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.

  Baseline compared to immediately after intervention.

Other Outcomes (1)

• Study 1 (feasibility study and RCT): Adverse events and serious adverse events.

  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.

Study Arms (2)

Mindfulness-based stress reduction (MBSR)

EXPERIMENTAL

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

Behavioral: Mindfulness-based stress reduction (MBSR)

Treatment as usual (TAU)

ACTIVE COMPARATOR

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

Behavioral: Treatment as usual (TAU)

Interventions

Mindfulness-based stress reduction (MBSR) BEHAVIORAL

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

Mindfulness-based stress reduction (MBSR)

Treatment as usual (TAU) BEHAVIORAL

Different interventions and support in outpatient and other services.

Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

MeSH Terms

Conditions

Patient Participation; Mental Disorders; Behavior; Stress, Psychological; Autistic Disorder

Interventions

Mindfulness-Based Stress Reduction; Therapeutics

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavioral Symptoms; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Open feasibility study: no masking. RCT: during the screening, assessment of eligibility and completion of T1 (baseline), the allocation to a specific study arm is masked. After T1, all participants, care provider and investigators know which arm (group or treatment as usual) was allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: First study is an open feasibility study, and the second one is a RCT with two parallel group study arms.

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: January 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-02