'Go With the Flow': Effects of Mindful Self-Compassion in Psychiatric Rehabilitation

Meditation Clinical Trial

Official title:

'Go With the Flow': Effects of Mindful Self-Compassion in Psychiatric Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04917081
• Other study ID #: MUGrazXXX
• Status: Completed
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: August 11, 2021

Study information

• Verified date: April 2022
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: August 11, 2021
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Psychiatric diagnosis

2. Signed informed consent form

3. Full command of the German language

Exclusion Criteria:

1. Age <18 years

2. Acute psychotic episode, acute suicidal tendencies, and acute addiction disorders

Related Conditions & MeSH terms

• Meditation
• Progressive Muscle Relaxation

Intervention

Behavioral:
• Mindful Self-Compassion
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 Relaxation
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.

Locations

Country	Name	City	State
Austria	pro mente REHA, Sonnenpark Neusiedlersee	Rust	Burgenland

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	pro mente REHA

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inventory of Personality Organization (IPO-16)	Personality structure will be assessed with the IPO-16 which consists of the three subscales identity diffusion, primitive defenses, and reality testing. The 16 items (identity diffusion: 6 items; primitive defenses: 5 items; reality testing: 5 items) are rated on a five-point Likert scale ranging from 1 (never) to 5 (always). A global index is used for statistical analysis, which is gathered by the mean of all items and ranges between 1 and 5. A higher value indicates a higher structural impairment.	Baseline and 1 day after the last intervention
Other	Experience in Close Relationships (Revised, German Version; ECR-RD12)	To assess general attachment patterns, the ECR-RD12 will be used. This questionnaire assesses attachment-related anxiety (6 items) and attachment-related avoidance (6 items) with a total of 12 items, rated on a seven-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Scale-scores range between 1 and 7. Higher scores on one or both dimensions are considered to indicate an insecure adult attachment orientation. Lower scores indicate a secure adult attachment orientation.	Baseline and 1 day after the last intervention
Other	Sex	Two questions are used to assess sex at birth and current sex with the following response options: 1 - female, 2 - male, 3 - transgender, 4 - other.	Baseline and 1 day after the last intervention
Other	Age	Digit entry	Baseline
Other	Weight and Height (BMI)	Weight (kg) and height (cm) will be assessed by digits entry and subsequently transformed into BMI.	Baseline and 1 day after the last intervention
Other	Education	Education will be assessed via six response options (1 - compulsory education, 2 - completed apprenticeship, 3 - vocational high school, 4 - high school, 5 - college degree, 6 - university degree).	Baseline
Other	Employment	Employment will be assessed via four response options (1 - standing in the profession, 2 - in education, 3 - retired, 4 - without gainful employment).	Baseline
Other	Marital status	Marital status will be assessed via four response options (1 - married, 2 - partnership, 3 - single, 4 - widowed/divorced).	Baseline
Other	Confession	Confession will be assessed via six response options (1 - Christianity, 2 - Buddhism, 3 - Hinduism, 4 - Islam, 5 - none, 6 - other).	Baseline
Other	Children	Participants are asked whether they have children using a dichotomous response format (0 - no, 1- yes).	Baseline
Other	Diet	Dietary habits will be assessed with the following response options: 1 - with a lot of meat, 2 - with little meat, 3 - with meat and rich in fruits and vegetables, 4 - vegetarian with fish and/or milk/eggs, 5 - vegan.; In addition, it is also asked whether this diet has been followed for at least 6 months (0 - no, 1 - yes).	Baseline and 1 day after the last intervention
Other	Cigarettes per day	Digit entry	Baseline and 1 day after the last intervention
Other	Alcohol consumption	dichotomous response format (0 - no, 1 - yes)	Baseline and 1 day after the last intervention
Other	Consumption of illegal drugs	dichotomous response format (0 - no, 1 - yes)	Baseline and 1 day after the last intervention
Other	Medication	Medication will be assessed by free answer.	Baseline and 1 day after the last intervention
Other	Mental illness	Mental illness will be assessed by free answer.	Baseline and 1 day after the last intervention
Other	Subjective feeling of health	Subjective feeling of health will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).	Baseline and 1 day after the last intervention
Other	Religiosity	Religiosity will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).	Baseline and 1 day after the last intervention
Other	Spirituality	Spirituality will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).	Baseline and 1 day after the last intervention
Other	Previous experience with meditation	dichotomous response format (0 - no, 1 - yes)	Baseline
Other	Previous experience with yoga	dichotomous response format (0 - no, 1 - yes)	Baseline
Other	Previous experience with mindfulness	dichotomous response format (0 - no, 1 - yes)	Baseline
Other	Previous experience with Progressive Muscle Relaxation (PMR)	dichotomous response format (0 - no, 1 - yes)	Baseline
Other	Previous experience with Mindful Self-Compassion (MSC)	dichotomous response format (0 - no, 1 - yes)	Baseline
Other	Practice of the learned practice (either PMR or MSC)	dichotomous response format (0 - no, 1 - yes); if answered with "yes" (I practice PMR/MSC) it is asked for the frequency of practice (1 - daily, 2 - several times a week, 3 - once a week, 4 - less than once a week), the duration of practice (1 - less than 10 minutes, 2 - 10-15 minutes, 3 - more than 15 minutes), and the type of practice (1 - ritualized, 2 - informal)	1 day after the last intervention
Other	Sympathy of the learned practice (either PMR or MSC)	Subjective sympathy of the learned practice will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).	1 day after the last intervention
Other	Sympathy of the trainer (either PMR or MSC)	Subjective sympathy of the trainer will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).	1 day after the last intervention
Primary	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.	Baseline and 1 day after the last intervention
Primary	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.	Baseline and 1 day after the last intervention
Primary	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).	1 day after the last intervention
Secondary	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.	Baseline and 1 day after the last intervention
Secondary	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.	Baseline and 1 day after the last intervention
Secondary	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.	Baseline and 1 day after the last intervention
Secondary	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.	Baseline and 1 day after the last intervention
Secondary	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".	every day during the stay at the rehabilitation clinic