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

Study Overview
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Brief Summary
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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.

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

Conditions
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Meditation, Progressive Muscle Relaxation

Intervention / Treatment
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* Behavioral: Mindful Self-Compassion
* Behavioral: Progressive Muscle Relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Psychiatric diagnosis Signed informed consent form Full command of the German language Exclusion Criteria: Age <18 years Acute psychotic episode, acute suicidal tendencies, and acute addiction disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Self-Compassion<br> | Behavioral: Mindful Self-Compassion<br>* 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.<br>|
| Active Comparator: Progressive Muscle Relaxation<br> | Behavioral: Progressive Muscle Relaxation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindful Self-Compassion