Clinical trial NCT04917081: 'Go With the Flow': Effects of Mindful Self-Compassion in Psychiatric Rehabilitation
Official title: 'Go With the Flow': Effects of Mindful Self-Compassion in Psychiatric Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meditation
Progressive Muscle Relaxation
Keywords: Mindful Self-Compassion
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: pro mente REHA
First posted: 2021-06-08
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Emotion Regulation Questionnaire (ERQ)
timeFrame: Baseline and 1 day after the last intervention
measure: Change in Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline and 1 day after the last intervention
measure: Reappraisal Inventiveness Test (RIT)
timeFrame: 1 day after the last intervention
Secondary outcomes:
measure: Change in Self-Compassion Scale (SCS)
timeFrame: Baseline and 1 day after the last intervention
measure: Change in Short-Form-Health Survey (SF-12)
timeFrame: Baseline and 1 day after the last intervention
measure: Change in Brief Symptom Inventory (BSI-18)
timeFrame: Baseline and 1 day after the last intervention
measure: Change in Multidimensional Inventory for Religious/Spiritual Well-Being 12 (MI-RSB 12)
timeFrame: Baseline and 1 day after the last intervention
measure: Change in Happiness
timeFrame: every day during the stay at the rehabilitation clinic
Other outcomes:
measure: Inventory of Personality Organization (IPO-16)
timeFrame: Baseline and 1 day after the last intervention
measure: Experience in Close Relationships (Revised, German Version; ECR-RD12)
timeFrame: Baseline and 1 day after the last intervention
measure: Sex
timeFrame: Baseline and 1 day after the last intervention
measure: Age
timeFrame: Baseline
measure: Weight and Height (BMI)
timeFrame: Baseline and 1 day after the last intervention
measure: Education
timeFrame: Baseline
measure: Employment
timeFrame: Baseline
measure: Marital status
timeFrame: Baseline
measure: Confession
timeFrame: Baseline
measure: Children
timeFrame: Baseline
measure: Diet
timeFrame: Baseline and 1 day after the last intervention
measure: Cigarettes per day
timeFrame: Baseline and 1 day after the last intervention
measure: Alcohol consumption
timeFrame: Baseline and 1 day after the last intervention
measure: Consumption of illegal drugs
timeFrame: Baseline and 1 day after the last intervention
measure: Medication
timeFrame: Baseline and 1 day after the last intervention
measure: Mental illness
timeFrame: Baseline and 1 day after the last intervention
measure: Subjective feeling of health
timeFrame: Baseline and 1 day after the last intervention
measure: Religiosity
timeFrame: Baseline and 1 day after the last intervention
measure: Spirituality
timeFrame: Baseline and 1 day after the last intervention
measure: Previous experience with meditation
timeFrame: Baseline
measure: Previous experience with yoga
timeFrame: Baseline
measure: Previous experience with mindfulness
timeFrame: Baseline
measure: Previous experience with Progressive Muscle Relaxation (PMR)
timeFrame: Baseline
measure: Previous experience with Mindful Self-Compassion (MSC)
timeFrame: Baseline
measure: Practice of the learned practice (either PMR or MSC)
timeFrame: 1 day after the last intervention
measure: Sympathy of the learned practice (either PMR or MSC)
timeFrame: 1 day after the last intervention
measure: Sympathy of the trainer (either PMR or MSC)
timeFrame: 1 day after the last intervention
Locations:
city: Rust
country: Austria
facility: pro mente REHA, Sonnenpark Neusiedlersee
state: Burgenland
Study officials:
affiliation: Medical University Graz, Department of Psychiatry and Psychotherapeutic Medicine
name: Human-Friedrich Unterrainer, PD DDr.
role: PRINCIPAL_INVESTIGATOR
References: