pro mente REHA, Sonnenpark Neusiedlersee
Rust, Burgenland, 7071, Austria
NCT Number: NCT04917081
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rust, Burgenland, 7071, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
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.
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).
Time frame: Baseline and 1 day after the last intervention
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.
Time frame: Baseline and 1 day after the last intervention
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.
Time frame: Baseline and 1 day after the last intervention
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.
Time frame: Baseline and 1 day after the last intervention
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.
Time frame: every day during the stay at the rehabilitation clinic
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".
Time frame: Baseline and 1 day after the last intervention
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.
Time frame: Baseline and 1 day after the last intervention
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.
Time frame: Baseline and 1 day after the last intervention
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.
Time frame: Baseline
Digit entry
Time frame: Baseline and 1 day after the last intervention
Weight (kg) and height (cm) will be assessed by digits entry and subsequently transformed into BMI.
Time frame: Baseline
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).
Time frame: Baseline
Employment will be assessed via four response options (1 - standing in the profession, 2 - in education, 3 - retired, 4 - without gainful employment).
Time frame: Baseline
Marital status will be assessed via four response options (1 - married, 2 - partnership, 3 - single, 4 - widowed/divorced).
Time frame: Baseline
Confession will be assessed via six response options (1 - Christianity, 2 - Buddhism, 3 - Hinduism, 4 - Islam, 5 - none, 6 - other).
Time frame: Baseline
Participants are asked whether they have children using a dichotomous response format (0 - no, 1- yes).
Time frame: Baseline and 1 day after the last intervention
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).
Time frame: Baseline and 1 day after the last intervention
Digit entry
Time frame: Baseline and 1 day after the last intervention
dichotomous response format (0 - no, 1 - yes)
Time frame: Baseline and 1 day after the last intervention
dichotomous response format (0 - no, 1 - yes)
Time frame: Baseline and 1 day after the last intervention
Medication will be assessed by free answer.
Time frame: Baseline and 1 day after the last intervention
Mental illness will be assessed by free answer.
Time frame: Baseline and 1 day after the last intervention
Subjective feeling of health will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).
Time frame: Baseline and 1 day after the last intervention
Religiosity will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).
Time frame: Baseline and 1 day after the last intervention
Spirituality will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).
Time frame: Baseline
dichotomous response format (0 - no, 1 - yes)
Time frame: Baseline
dichotomous response format (0 - no, 1 - yes)
Time frame: Baseline
dichotomous response format (0 - no, 1 - yes)
Time frame: Baseline
dichotomous response format (0 - no, 1 - yes)
Time frame: Baseline
dichotomous response format (0 - no, 1 - yes)
Time frame: 1 day after the last intervention
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)
Time frame: 1 day after the last intervention
Subjective sympathy of the learned practice will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).
Time frame: 1 day after the last intervention
Subjective sympathy of the trainer will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).
Medical University of Graz
Other
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