MeditationNCT04917081
'Go With the Flow': Effects of Mindful Self-Compassion in Psychiatric Rehabilitation
A study testing Mindful Self-Compassion and Progressive Muscle Relaxation in people with Meditation and Progressive Muscle Relaxation, run by Medical University of Graz at 1 site in Austria.
Trial summary
This study is designed as a randomized controlled trial to gain further insights into possible effects of a standardized 6-week Mindful Self-Compassion (MSC) training on psychiatric rehabilitation inpatients and aims to generate insights into which parameters of mental health, and especially emotion regulation, can be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meditation, Progressive Muscle Relaxation
- What is being tested?
- Mindful Self-Compassion and Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteAustria
- Study dates
- 11 Sep 2020to 11 Aug 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
- Psychiatric diagnosis
- Signed informed consent form
- Full command of the German language
Who cannot join
- Age <18 years
- Acute psychotic episode, acute suicidal tendencies, and acute addiction disorders
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed as a randomized controlled trial to gain further insights into possible effects of a standardized 6-week Mindful Self-Compassion (MSC) training on psychiatric rehabilitation inpatients and aims
- to generate insights into which parameters of mental health, and especially emotion regulation, can be improved by MSC in this setting,
- to compare effects of MSC training with an established relaxation training (i.e., progressive muscle relaxation; PMR) and
- to determine the general conditions and patient characteristics influencing the effectiveness of MSC training.
- Conditions
- Meditation, Progressive Muscle Relaxation
- Being tested
- Mindful Self-Compassion, Progressive Muscle Relaxation
- Keywords
- Mindful Self-Compassion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Self-CompassionBehavioural
Mindful Self-Compassion has been developed by Neff and Germer as a specific kind of Mindfulness-Based Interventions to promote self-compassion. It combines the skills of mindfulness and self-compassion, providing a powerful tool for emotional resilience and enhancing the capacity for emotional wellbeing. In this study, a shortened version of the MSC program is used which is applied once a week for 75 minutes throughout the patients' stay in the rehabilitation clinic.
Progressive Muscle RelaxationBehavioural
Progressive Muscle Relaxation by Jacobson is a deep relaxation technique that helps relieve muscle tension and is based on the premise that mental calmness is a natural result of physical relaxation. In this study, Progressive Muscle Relaxation is applied once a week for 75 minutes throughout the patients' stay in the rehabilitation clinic.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Self-Compassion | Experimental | Not described Receives: Behavioral: Mindful Self-Compassion |
| Progressive Muscle Relaxation | Active comparator | Not described Receives: Behavioral: Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotion Regulation Questionnaire (ERQ)
The Emotion Regulation Questionnaire (ERQ) measures two common emotion regulation strategies (cognitive reappraisal and expressive suppression) with a total of 10 items (reappraisal scale: 6 items; suppression scale: 4 items), which are answered on a seven-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The higher the score of a scale (mean value ranging from 1 to 7), the more frequently the respective emotion regulation strategy is used.
Measured: Baseline and 1 day after the last intervention
Change in Positive and Negative Affect Schedule (PANAS)
The Positive and Negative Affect Schedule (PANAS) consists of 20 items and captures two dispositional dimensions (positive affect and negative affect), 10 items for each scale. A five-point Likert scale (1 - very slightly to 5 - extremely) is used. Mean scores for each of the two scales can range from 1 to 5, with lower scores representing lower levels of positive/negative affect and higher scores representing higher levels of positive/negative affect.
Measured: Baseline and 1 day after the last intervention
Reappraisal Inventiveness Test (RIT)
The Reappraisal Inventiveness Test (RIT) assesses emotion regulation abilities on a behavioral level. Participants generate cognitive reappraisals for different anger-provoking situations to reduce their anger. The fluency (total number of generated nonidentical ideas that qualified as cognitive reappraisals) and flexibility (number of categorically different reappraisals) of these reappraisals are measured. The given answers will be independently rated by two researchers. In addition, the intensity of induced anger will be assessed with a seven-point Likert scale from 0 (not at all) to 6 (very).
Measured: 1 day after the last intervention
Secondary outcomes (5)
Change in Self-Compassion Scale (SCS)
SCS captures the amount of self-compassion by means of 26 items answered on a five-point Likert scale (1 to 5). A higher value (mean value ranging from 1 to 5) indicates a higher level of self-compassion.
Measured: Baseline and 1 day after the last intervention
Change in Short-Form-Health Survey (SF-12)
SF-12 measures quality of life via 12 items answered with different response formats. The items are weighted and summed to provide a physical and mental health score ranging from 0 to 100, with a higher score indicating better health.
Measured: Baseline and 1 day after the last intervention
Change in Brief Symptom Inventory (BSI-18)
The BSI-18 assesses psychiatric symptoms in three dimensions (somatization, depression and anxiety), which can be summarized in a global severity index (GSI). It contains 18 items that are answered on a five-point Likert scale ranging from 0 (not at all) to 4 (extremely). Higher values (ranging from 0 to 24 in the three dimensions; ranging from 0 to 72 in the GSI) indicate a greater severity of symptoms.
Measured: Baseline and 1 day after the last intervention
Change in Multidimensional Inventory for Religious/Spiritual Well-Being 12 (MI-RSB 12)
The MI-RSB 12 captures four different dimensions of religious and spiritual well-being, namely general religiosity, forgiveness, connectedness, and immanent hope, which can be collated into a total amount of religious/spiritual well-being (RSB). The instrument consists of 12 items, three items per dimension, answered via a six-point Likert scale (1 - strongly disagree to 6 - strongly agree). Scores range from 3 to 18 for each subscale and from 12 to 72 for the overall score of the RSB. Higher scores indicate higher religious and spiritual well-being.
Measured: Baseline and 1 day after the last intervention
Change in Happiness
The amount of subjective happiness will be captured by one item, which has to be answered on a 10-point Likert scale, with 1 indicating "not happy at all" and 10 "absolutely happy".
Measured: every day during the stay at the rehabilitation clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start11 Sep 2020
- Primary completion11 Aug 2021
- Study completion11 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeditationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- pro mente REHA
- Responsible party
- Sponsor
- Investigators
- Human-Friedrich Unterrainer, PD DDr., Principal investigator, Medical University Graz, Department of Psychiatry and Psychotherapeutic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917081
- Sponsor's protocol ID
- MUGrazXXX
- Status last verified
- Apr 2022
- First submitted
- 27 May 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Go With the Flow': Effects of Mindful Self-Compassion in Psychiatric Rehabilitation
- ClinicalTrials.gov ID
- NCT04917081
- Acronym / sponsor ID
- MUGrazXXX
- Conditions
- Meditation, Progressive Muscle Relaxation
- Keywords
- Mindful Self-Compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- pro mente REHA
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 11 Aug 2021 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 8 Jun 2021 (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 study is designed as a randomized controlled trial to gain further insights into possible effects of a standardized 6-week Mindful Self-Compassion (MSC) training on psychiatric rehabilitation inpatients and aims
- to generate insights into which parameters of mental health, and especially emotion regulation, can be improved by MSC in this setting,
- to compare effects of MSC training with an established relaxation training (i.e., progressive muscle relaxation; PMR) and
- to determine the general conditions and patient characteristics influencing the effectiveness of MSC training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Self-Compassion | Experimental | Behavioral: Mindful Self-Compassion |
| Progressive Muscle Relaxation | Active comparator | Behavioral: Progressive Muscle Relaxation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Psychiatric diagnosis
- Signed informed consent form
- Full command of the German language
Key exclusion criteria (2 listed)
- Age <18 years
- Acute psychotic episode, acute suicidal tendencies, and acute addiction disorders
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 |
|---|---|---|
| Mindful Self-CompassionMindful Self-Compassion has been developed by Neff and Germer as a specific kind of Mindfulness-Based Interventions to promote self-compassion. It combines the skills of mindfulness and self-compassion, providing a powerful tool for emotional resilience and enhancing the capacity for emotional wellbeing. In this study, a shortened version of the MSC program is used which is applied once a week for 75 minutes throughout the patients' stay in the rehabilitation clinic. | Behavioural | Mindful Self-Compassion |
| Progressive Muscle RelaxationProgressive Muscle Relaxation by Jacobson is a deep relaxation technique that helps relieve muscle tension and is based on the premise that mental calmness is a natural result of physical relaxation. In this study, Progressive Muscle Relaxation is applied once a week for 75 minutes throughout the patients' stay in the rehabilitation clinic. | Behavioural | Progressive Muscle Relaxation |
Primary outcome
Change in Emotion Regulation Questionnaire (ERQ)
Time frame: Baseline and 1 day after the last intervention
The Emotion Regulation Questionnaire (ERQ) measures two common emotion regulation strategies (cognitive reappraisal and expressive suppression) with a total of 10 items (reappraisal scale: 6 items; suppression scale: 4 items), which are answered on a seven-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The higher the score of a scale (mean value ranging from 1 to 7), the more frequently the respective emotion regulation strategy is used.
Change in Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline and 1 day after the last intervention
The Positive and Negative Affect Schedule (PANAS) consists of 20 items and captures two dispositional dimensions (positive affect and negative affect), 10 items for each scale. A five-point Likert scale (1 - very slightly to 5 - extremely) is used. Mean scores for each of the two scales can range from 1 to 5, with lower scores representing lower levels of positive/negative affect and higher scores representing higher levels of positive/negative affect.
Reappraisal Inventiveness Test (RIT)
Time frame: 1 day after the last intervention
The Reappraisal Inventiveness Test (RIT) assesses emotion regulation abilities on a behavioral level. Participants generate cognitive reappraisals for different anger-provoking situations to reduce their anger. The fluency (total number of generated nonidentical ideas that qualified as cognitive reappraisals) and flexibility (number of categorically different reappraisals) of these reappraisals are measured. The given answers will be independently rated by two researchers. In addition, the intensity of induced anger will be assessed with a seven-point Likert scale from 0 (not at all) to 6 (very).
5 secondary outcomes
Change in Self-Compassion Scale (SCS)
Time frame: Baseline and 1 day after the last intervention
Change in Short-Form-Health Survey (SF-12)
Time frame: Baseline and 1 day after the last intervention
Change in Brief Symptom Inventory (BSI-18)
Time frame: Baseline and 1 day after the last intervention
Change in Multidimensional Inventory for Religious/Spiritual Well-Being 12 (MI-RSB 12)
Time frame: Baseline and 1 day after the last intervention
Change in Happiness
Time frame: every day during the stay at the rehabilitation clinic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Human-Friedrich Unterrainer, PD DDr. principal investigator
Medical University Graz, Department of Psychiatry and Psychotherapeutic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Self-Compassion and Progressive Muscle Relaxation in people with Meditation and Progressive Muscle Relaxation, run by Medical University of Graz at 1 site in Austria.
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 2 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: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Emotion Regulation Questionnaire (ERQ) (time frame: Baseline and 1 day after the last 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 6 Apr 2022.