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

NCT04917081 | Completed

• 1 other identifier: MUGrazXXX
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

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.

Conditions

Meditation; Progressive Muscle Relaxation

Keywords

Mindful Self-Compassion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Change in Self-Compassion Scale (SCS)

  Baseline and 1 day after the last intervention

• Change in Short-Form-Health Survey (SF-12)

  Baseline and 1 day after the last intervention

• Change in Brief Symptom Inventory (BSI-18)

  Baseline and 1 day after the last intervention

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

  Baseline and 1 day after the last intervention

• Change in Happiness

  every day during the stay at the rehabilitation clinic

Other Outcomes (27)

• Inventory of Personality Organization (IPO-16)

  Baseline and 1 day after the last intervention

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

  Baseline and 1 day after the last intervention

• Sex

  Baseline and 1 day after the last intervention

Study Arms (2)

Mindful Self-Compassion

EXPERIMENTAL

Behavioral: Mindful Self-Compassion

Progressive Muscle Relaxation

ACTIVE COMPARATOR

Behavioral: Progressive Muscle Relaxation

Interventions

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.

Mindful Self-Compassion

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.

Progressive Muscle Relaxation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Psychiatric diagnosis
• Signed informed consent form
• Full command of the German language

You may not qualify if:

• Age \<18 years
• Acute psychotic episode, acute suicidal tendencies, and acute addiction disorders

Sponsors & Collaborators

• Medical University of Graz: lead
• pro mente REHA: collaborator

Study Sites (1)

pro mente REHA, Sonnenpark Neusiedlersee

Rust, Burgenland, 7071, Austria

Location

MeSH Terms

Interventions

Autogenic Training

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Human-Friedrich Unterrainer, PD DDr.

  Medical University Graz, Department of Psychiatry and Psychotherapeutic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 8, 2021
• Study Start: September 11, 2020
• Primary Completion: August 11, 2021
• Study Completion: August 11, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)