Ignite Creation Date:
2024-05-06 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05244265
Status:
TERMINATED
Last Update Posted:
2022-03-08
First Post:
2022-02-08
Brief Title:
Mindfulness Based Stress Reduction for Intellectually Able Autistic Adults
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Mindfulness Based Stress Reduction MBSR for Intellectually Able Autistic Adults
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Covid-19 pandemic hindered the group based intervention
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None