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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04917081
Enrollment
233
Registered
2021-06-08
Start date
2020-09-11
Completion date
2021-08-11
Last updated
2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meditation, Progressive Muscle Relaxation

Keywords

Mindful Self-Compassion

Brief 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.

Interventions

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.

BEHAVIORALProgressive 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.

Sponsors

pro mente REHA
CollaboratorOTHER
Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Emotion Regulation Questionnaire (ERQ)Baseline and 1 day after the last interventionThe 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)Baseline and 1 day after the last interventionThe 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)1 day after the last interventionThe 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

MeasureTime frameDescription
Change in Multidimensional Inventory for Religious/Spiritual Well-Being 12 (MI-RSB 12)Baseline and 1 day after the last interventionThe 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.
Change in Self-Compassion Scale (SCS)Baseline and 1 day after the last interventionSCS 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.
Change in Happinessevery day during the stay at the rehabilitation clinicThe 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.
Change in Short-Form-Health Survey (SF-12)Baseline and 1 day after the last interventionSF-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.
Change in Brief Symptom Inventory (BSI-18)Baseline and 1 day after the last interventionThe 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.

Other

MeasureTime frameDescription
ConfessionBaselineConfession will be assessed via six response options (1 - Christianity, 2 - Buddhism, 3 - Hinduism, 4 - Islam, 5 - none, 6 - other).
ChildrenBaselineParticipants are asked whether they have children using a dichotomous response format (0 - no, 1- yes).
DietBaseline and 1 day after the last interventionDietary 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).
Cigarettes per dayBaseline and 1 day after the last interventionDigit entry
Alcohol consumptionBaseline and 1 day after the last interventiondichotomous response format (0 - no, 1 - yes)
Consumption of illegal drugsBaseline and 1 day after the last interventiondichotomous response format (0 - no, 1 - yes)
MedicationBaseline and 1 day after the last interventionMedication will be assessed by free answer.
Mental illnessBaseline and 1 day after the last interventionMental illness will be assessed by free answer.
Subjective feeling of healthBaseline and 1 day after the last interventionSubjective feeling of health will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).
Inventory of Personality Organization (IPO-16)Baseline and 1 day after the last interventionPersonality 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.
SpiritualityBaseline and 1 day after the last interventionSpirituality will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).
Previous experience with meditationBaselinedichotomous response format (0 - no, 1 - yes)
Previous experience with yogaBaselinedichotomous response format (0 - no, 1 - yes)
Previous experience with mindfulnessBaselinedichotomous response format (0 - no, 1 - yes)
Previous experience with Progressive Muscle Relaxation (PMR)Baselinedichotomous response format (0 - no, 1 - yes)
Previous experience with Mindful Self-Compassion (MSC)Baselinedichotomous response format (0 - no, 1 - yes)
Practice of the learned practice (either PMR or MSC)1 day after the last interventiondichotomous 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)
Sympathy of the learned practice (either PMR or MSC)1 day after the last interventionSubjective sympathy of the learned practice will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).
Sympathy of the trainer (either PMR or MSC)1 day after the last interventionSubjective sympathy of the trainer will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).
ReligiosityBaseline and 1 day after the last interventionReligiosity will be captured via a ten-point rating scale (1 - not at all to 10 - absolutely).
Experience in Close Relationships (Revised, German Version; ECR-RD12)Baseline and 1 day after the last interventionTo 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.
SexBaseline and 1 day after the last interventionTwo questions are used to assess sex at birth and current sex with the following response options: 1 - female, 2 - male, 3 - transgender, 4 - other.
AgeBaselineDigit entry
Weight and Height (BMI)Baseline and 1 day after the last interventionWeight (kg) and height (cm) will be assessed by digits entry and subsequently transformed into BMI.
EducationBaselineEducation 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).
EmploymentBaselineEmployment will be assessed via four response options (1 - standing in the profession, 2 - in education, 3 - retired, 4 - without gainful employment).
Marital statusBaselineMarital status will be assessed via four response options (1 - married, 2 - partnership, 3 - single, 4 - widowed/divorced).

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026