Treatment SatisfactionNCT05244265
Mindfulness Based Stress Reduction for Intellectually Able Autistic Adults
A study testing Mindfulness-based stress reduction (MBSR) and Treatment as usual (TAU) in people with Treatment Satisfaction and Participation Rate, Patient, run by Karolinska Institutet.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Satisfaction, Participation Rate, Patient, Quality of Life
- What is being tested?
- Mindfulness-based stress reduction (MBSR) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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
- Being tested
- Mindfulness-based stress reduction (MBSR), Treatment as usual (TAU)
- Keywords
- Autism, Adults, Intervention, MBSR
- Medical subject headings
- Patient Participation, Mental Disorders, Behavior, Stress, Psychological, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reduction (MBSR)Behavioural
The 8 week (plus one-day retreat) manualized MBSR program according to the manual (Kabat-Zinn, 1982).
Treatment as usual (TAU)Behavioural
Different interventions and support in outpatient and other services.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based stress reduction (MBSR) | Experimental | The 9 session MBSR program following the manual (Kabat-Zinn, 1982). Receives: 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. Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
14 statements scored on a five-point Likert-scale (0-4) where higher points indicate higher perceived stress.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Jan 2016
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: Covid-19 pandemic hindered the group based intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment SatisfactionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- First study is an open feasibility study, and the second one is a RCT with two parallel group study arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Tatja Hirvikoski, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244265
- Sponsor's protocol ID
- MBSRautisticAdults
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Stress Reduction (MBSR) for Intellectually Able Autistic Adults
- ClinicalTrials.gov ID
- NCT05244265
- Acronym / sponsor ID
- MBSRautisticAdults
- Conditions
- Treatment Satisfaction, Participation Rate, Patient, Quality of Life, Mental Illness, Acceptance Processes, Stress, Psychological
- Keywords
- Autism, Adults, Intervention, MBSR
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19 pandemic hindered the group based intervention
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- First study is an open feasibility study, and the second one is a RCT with two parallel group study arms.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based stress reduction (MBSR) | Experimental | Behavioral: Mindfulness-based stress reduction (MBSR)The 9 session MBSR program following the manual (Kabat-Zinn, 1982). |
| Treatment as usual (TAU) | Active comparator | Behavioral: Treatment as usual (TAU)Participants take part in their treatment as usual in outpatient habilitation and other services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based stress reduction (MBSR)The 8 week (plus one-day retreat) manualized MBSR program according to the manual (Kabat-Zinn, 1982). | Behavioural | Mindfulness-based stress reduction (MBSR) |
| Treatment as usual (TAU)Different interventions and support in outpatient and other services. | Behavioural | Treatment as usual (TAU) |
Primary outcome
Study 1 (feasibility study): Treatment completion.
Time frame: Immediately after intervention.
Participants attending six or more out of the total nine occasions (eight sessions and one retreat) (≥66%) were considered completers.
Study 1 (feasibility study): Credibility as measured by the Treatment Credibility Scale (TCS: Borkovec & Nau, 1972).
Time frame: Baseline compared to immediately after intervention.
Five statements scored on a ten-point Likert scale where higher points indicate higher treatment credibility.
Study 2 (RCT): Perceived stress as measured by the Perceived stress scale (Cohen et al., 1983).
Time frame: Change from baseline to immediately after the intervention.
14 statements scored on a five-point Likert-scale (0-4) where higher points indicate higher perceived stress.
9 secondary outcomes
Study 1 (feasibility study): Perceived stress as measured by the Perceived stress scale (Cohen et al., 1983).
Time frame: 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).
Time frame: 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).
Time frame: Baseline compared to immediately after intervention.
Study 1 (feasibility study): Mindfulness, assessed by Mindful attention awareness scale (MAAS: Brown & Ryan, 2003).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Change from baseline to immediately after the intervention.
Study 2 (RCT): Five Facets Mindfulness Questionnaire
Time frame: 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.
Time frame: Change from baseline to immediately after the intervention.
Results and safety
The study was stopped early (reason given: Covid-19 pandemic hindered the group based intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction (MBSR) and Treatment as usual (TAU) in people with Treatment Satisfaction and Participation Rate, Patient, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid-19 pandemic hindered the group based intervention). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study 1 (feasibility study): Treatment completion. (time frame: Immediately after intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.