Skip to main content
OpenTrials
Completed

NCT Number: NCT04917081

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

pro mente REHA, Sonnenpark Neusiedlersee

Rust, Burgenland, 7071, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindful Self-Compassion

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. Change in Self-Compassion Scale (SCS)

    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.

  2. Change in Short-Form-Health Survey (SF-12)

    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.

  3. Change in Brief Symptom Inventory (BSI-18)

    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.

  4. Change in Multidimensional Inventory for Religious/Spiritual Well-Being 12 (MI-RSB 12)

    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.

  5. Change in Happiness

    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".

Other outcomes

  1. Inventory of Personality Organization (IPO-16)

    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.

  2. Experience in Close Relationships (Revised, German Version; ECR-RD12)

    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.

  3. Sex

    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.

  4. Age

    Time frame: Baseline

    Digit entry

  5. Weight and Height (BMI)

    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.

  6. Education

    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).

  7. Employment

    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).

  8. Marital status

    Time frame: Baseline

    Marital status will be assessed via four response options (1 - married, 2 - partnership, 3 - single, 4 - widowed/divorced).

  9. Confession

    Time frame: Baseline

    Confession will be assessed via six response options (1 - Christianity, 2 - Buddhism, 3 - Hinduism, 4 - Islam, 5 - none, 6 - other).

  10. Children

    Time frame: Baseline

    Participants are asked whether they have children using a dichotomous response format (0 - no, 1- yes).

  11. Diet

    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).

  12. Cigarettes per day

    Time frame: Baseline and 1 day after the last intervention

    Digit entry

  13. Alcohol consumption

    Time frame: Baseline and 1 day after the last intervention

    dichotomous response format (0 - no, 1 - yes)

  14. Consumption of illegal drugs

    Time frame: Baseline and 1 day after the last intervention

    dichotomous response format (0 - no, 1 - yes)

  15. Medication

    Time frame: Baseline and 1 day after the last intervention

    Medication will be assessed by free answer.

  16. Mental illness

    Time frame: Baseline and 1 day after the last intervention

    Mental illness will be assessed by free answer.

  17. Subjective feeling of health

    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).

  18. Religiosity

    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).

  19. Spirituality

    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).

  20. Previous experience with meditation

    Time frame: Baseline

    dichotomous response format (0 - no, 1 - yes)

  21. Previous experience with yoga

    Time frame: Baseline

    dichotomous response format (0 - no, 1 - yes)

  22. Previous experience with mindfulness

    Time frame: Baseline

    dichotomous response format (0 - no, 1 - yes)

  23. Previous experience with Progressive Muscle Relaxation (PMR)

    Time frame: Baseline

    dichotomous response format (0 - no, 1 - yes)

  24. Previous experience with Mindful Self-Compassion (MSC)

    Time frame: Baseline

    dichotomous response format (0 - no, 1 - yes)

  25. Practice of the learned practice (either PMR or MSC)

    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)

  26. Sympathy of the learned practice (either PMR or MSC)

    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).

  27. Sympathy of the trainer (either PMR or MSC)

    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).

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • pro mente REHA

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2021
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.