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Clinical Trials/NCT04917081
NCT04917081CompletedNot Applicable

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

Medical University of Graz2 sites in 1 country233 target enrollmentStarted: September 11, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
233
Locations
2
Primary Endpoint
Change in Emotion Regulation Questionnaire (ERQ)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

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.

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

  • 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 Happiness(every day during the stay at the rehabilitation clinic)
  • Change in Multidimensional Inventory for Religious/Spiritual Well-Being 12 (MI-RSB 12)(Baseline and 1 day after the last intervention)

Investigators

Sponsor
Medical University of Graz
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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