Mindfulness Based Stress Reduction for Intellectually Able Autistic Adults

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05244265
• Other study ID #: MBSRautisticAdults
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: September 1, 2021

Study information

• Verified date: February 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Mindfulness-based stress reduction (MBSR)
The 8 week (plus one-day retreat) manualized MBSR program according to the manual (Kabat-Zinn, 1982).
• Treatment as usual (TAU)
Different interventions and support in outpatient and other services.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Outcome

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.