Mindful Self Compassion in Rehabilitation Inpatients

January 9, 2017 updated by: Mag. Lisza Gaiswinkler, Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin

Mindful Self Compassion in Rehabilitation Inpatients: a Randomized Controlled Trial

In recent years there has been convincing evidence of the positive effects of mindfulness based interventions, as a form of complementary and alternative medicine in regards to subjective well-being and physical health. There is growing evidence concerning the positive effects of these techniques in regards to an adequate stress management (e.g. respiration and heart rate variability). These findings can be found as well documented in the literature. For this study it is conducted to gain further insights into the role of mindfulness based meditation techniques for psychological well-being. Therefore it is intended to focus on clinical groups (e. g. depression and anxiety patients) in order to find out more about the relevance of mindfulness based meditation techniques as an adjunct for psychiatric and psychotherapeutic treatment. In this study special aspects of mental and spiritual health (e.g. self compassion, subjective perceived stress, spiritual well-being, and psychiatric symptoms) should be examined by comparing a group of clinical patients which practice mindfulness based meditation once a week with a control group, practicing PMR (progressive muscle relaxation)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A holistic view of man is increasingly becoming our consciousness these days. Simultaneously, the demand for efficient and cost-effective forms of treatment for mental illness rises. According to a study by the World Health Organization (2011), 37% of "healthy" working years are lost due to psychiatric disorders. Thus complementary-alternative methods (CAM) as mindfulness-based meditation are becoming more important in medicine. A special form of mindfulness meditation-based training offers "Mindful Self Compassion (MSC)" (to German: achtsames Selbstmitgefühl). As evidence-based sister program to the well-established procedure MBSR and MBCT, MSC provides about meditation, interpersonal exercises, informal practical exercises and homework, the opportunity to learn an attentive and loving contact with itself or to improve and thus contribute effectively to comprehensive well-being. The literature reveals that MSC helps to lead a fulfilling life and is positively related to life satisfaction, emotional intelligence, happiness, optimism and personal initiative. MSC is further negatively correlated with depression, anxiety, self-criticism, the suppression of negative emotions and a negative body image. Furthermore, it is apparent from a study by Blatt (1995) that patients who are very critical towards themselves tend to have less positive effects of antidepressants, placebo and psychotherapy. For this reason it seems of enormous relevance to develop and evaluate therapies, which can help to change people's perception of oneself, like MSC. Based on these results, which show a clear link between Self-Compassion and psychological well-being, a study should be carried out which examines the effects of mindful self compassion meditation on psychological well-being and the severity of clinical symptoms and thus allows a first assessment of effectiveness in clinical practice. A randomized controlled trial is investigated at the rehabilitation center "Sonnenpark Rust Neusiedlersee" where one group of patients (at least 70 patients anticipated) will undergo a shortened form (6 weeks, 75 minutes per week) of MSC training, compared to a group of patients (at least 70 patients anticipated) who undergo regular progressive muscle relaxation (PMR). Both trainings will take place once a week for 6 weeks and will each last for 75 minutes. Patients in both groups will be asked for homework assignments and will get a handout. All relevant parameters are examined at the beginning of the rehabilitation, as well as at the end of the stay at the center. A follow- up after 6 months is planned.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written consent for study participation
  • age over 18

Exclusion Criteria:

  • psychotic episode

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindful Self Compassion
Participants will receive a shortened form (6 weeks) of mindful self compassion meditation, once a week for 75 minutes, furthermore they get an audio cd and a handout to practice during the week
Behavioral: Mindful Self Compassion
Mindful Self Compassion (MSC) training has its primary focus on developing a friendly relationship with oneself by meditation,conversation with the group and the trainer, informal practice and homework assignments. These relationship is founded on mindfulness; therefore the participants will learn a way concentrate on the present moment. The orginal MSC training by Neff and Germer is well established, this intervention will be a shortened form of the original version and will last for the whole visit of the clinical patients in rehabilitation
Other: Progressive Muscle Relaxation
Participants will receive progressive muscle relaxation once a week for 75 minutes, furthermore they get an audio cd and a handout to practice during the week
Behavioral: Progressive Muscle Relaxation
Progressive Muscle Relaxation by Jacobson is a well known relaxation technique where participants learn to recognize the difference between tension and relaxation by tensing and subsequently relaxing the muscles. The trainingw ill last the wohole stay and the control group will also do homework assignments.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-Compassion Scale (SCS)
Time Frame: Change from Baseline values in SCS at 6 weeks, follow up 6 months after study completion
Self compassion is captured via 26 items on a 5-point rating scale. Self Compassion is measured at the beginning and at the end of the 6 weeks intervention
Change from Baseline values in SCS at 6 weeks, follow up 6 months after study completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brief Symptom Inventory (BSI-18)
Time Frame: Change from Baseline values BSI-18 at 6 weeks, follow up 6 months after study completion
Anxiety, Depression and Somatization as subscales and General Symptom Burden as global score are captured via 18 items on a 4-point rating scale.
Change from Baseline values BSI-18 at 6 weeks, follow up 6 months after study completion
Health Survey (SF-36)
Time Frame: Change from Baseline values in SF-36 at 6 weeks, follow up 6 months after study completion
Health-related quality of life is captured via 36 items over different answering conditions and has 8 subscales: physical functioning, physical role ,bodily pain, general health perceptions, vitality, social functioning, emotional role function and mental well-being
Change from Baseline values in SF-36 at 6 weeks, follow up 6 months after study completion

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sociodemographic Data/ Age
Time Frame: Baseline sociodemographic data, follow up 6 months after study completion
Digits entry
Baseline sociodemographic data, follow up 6 months after study completion
Sociodemographic Data/ Education
Time Frame: Baseline sociodemographic data, follow up 6 months after study completion
Education will be assessed by a 6-point rating scale: 1=compulsory education, 2= completed apprenticeship, 3=vocational high school, 4=high school, 5=college degree, 6= university degree and subsequently categorized (1=low education level (compulsory education, completed apprenticeship, vocational high school; 2= high education level (high school, college degree, university degree)
Baseline sociodemographic data, follow up 6 months after study completion
Sociodemographic Data/ Diet
Time Frame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
Dietary habits will be assessed by a 5-point rating scale (1=with meat, 2=with little meat, 3=with meat and rich in fruits and vegetables, 4=vegetarian with milk/eggs and/or fish, 5=vegan)
Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
Sociodemographic Data/ Weight and Height (BMI)
Time Frame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
Weight (kg) and Height (m) will be assessed by digits entry and subsequently transformed into BMI
Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
Sociodemographic Data/ Confession
Time Frame: Baseline sociodemographic data, follow up 6 months after study completion
Confession will be assessed by a 7-point rating scale (1=buddhism, 2=christianity 3=hinduism, 4=islam, 5=judaism, 6=none, 7=other)
Baseline sociodemographic data, follow up 6 months after study completion
Sociodemographic Data/ Diagnosis
Time Frame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
Diagnosis will be assessed by free answer and subsequently diagnosis will be categorized
Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
Sociodemographic Data/ Medication
Time Frame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
Medication will be assessed by free answer and subsequently diagnosis will be categorized
Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
Sociodemographic Data/ Level of Perceived Stress
Time Frame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
Level of Perceived Stress will be captured via 10 point rating scale (1=not at all - 10= absolutely)
Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
Sociodemographic Data/ Previous Experience with Meditation
Time Frame: Baseline sociodemographic data
dichotomous response format (0=no, 1=yes)
Baseline sociodemographic data
Sociodemographic Data/ Previous Experience with Progressive Muscle Relaxation
Time Frame: Baseline sociodemographic data
dichotomous response format (0=no, 1=yes)
Baseline sociodemographic data
Sociodemographic Data/ Previous Experience with Mindfulness
Time Frame: Baseline sociodemographic data
dichotomous response format (0=no, 1=yes)
Baseline sociodemographic data
Sociodemographic Data/ Employment
Time Frame: Baseline sociodemographic data, follow up 6 months after study completion
Employment will be assessed via 4-point rating scale (1=standing in the Profession, 2=in education, 3=retired, 4=without gainful employment)
Baseline sociodemographic data, follow up 6 months after study completion
Sociodemographic Data/ Marital Status
Time Frame: Baseline sociodemographic data, follow up 6 months after study completion
Marital Status will be assessed via 4-point rating scale (1=married, 2=partnership, 3=single, 4=widowed/divorced)
Baseline sociodemographic data, follow up 6 months after study completion
Sociodemographic Data/ Alcohol Consumption
Time Frame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
dichotomous response format (0=no, 1=yes)
Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
Sociodemographic Data/ Drug Consumption
Time Frame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
dichotomous response format (0=no, 1=yes)
Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
Sociodemographic Data/ Nicotine Consumption
Time Frame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
dichotomous response format (0=no, 1=yes), if answered with "yes" it is asked for the amount of cigarettes consumed per day
Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
Sociodemographic Data/ Sympathy of the learned practice (either MSC or PMR)
Time Frame: sociodemographic data at 6 weeks, follow up 6 months after study completion
will be captured via 10 point rating scale (1=not at all - 10= absolutely)
sociodemographic data at 6 weeks, follow up 6 months after study completion
Sociodemographic Data/ Sympathy of the trainer (either MSC or PMR)
Time Frame: sociodemographic data at 6 weeks, follow up 6 months after study completion
will be captured via 10 point rating scale (1=not at all - 10= absolutely)
sociodemographic data at 6 weeks, follow up 6 months after study completion
Sociodemographic Data/ Duration of Practice
Time Frame: sociodemographic data at 6 weeks, follow up 6 months after study completion
dichotomous response format (0=no, 1=yes), if answered with "yes" (I practice MSC/PMR) it is asked for the amount of practice per day with a 3-point rating scale (1=less than 10 minutes, 2= 10-15 minutes, 3=more than 15 minutes)
sociodemographic data at 6 weeks, follow up 6 months after study completion
Sociodemographic Data/ Frequency of Practice
Time Frame: sociodemographic data at 6 weeks, follow up 6 months after study completion
dichotomous response format (0=no, 1=yes), if answered with "yes" (I practice MSC/PMR) it is asked for the frequency of practice per day with a 4-point rating scale (1=daily, 2=serveral times a week, 3=once per week, 4=less than once a week)
sociodemographic data at 6 weeks, follow up 6 months after study completion
Sociodemographic Data/ Type of Practice
Time Frame: sociodemographic data at 6 weeks, follow up 6 months after study completion
dichotomous response format (0=no, 1=yes), if answered with "yes" (I practice MSC/PMR) it is asked for the type (ritualized vs. informal) of practice
sociodemographic data at 6 weeks, follow up 6 months after study completion
Subjective Feeling of Health
Time Frame: Changes from Baseline data at 6 weeks, follow up 6 months after study completion
will be captured via 10 point rating scale (1=not at all - 10= absolutely)
Changes from Baseline data at 6 weeks, follow up 6 months after study completion
Subjective Feeling of Happines
Time Frame: Changes from Baseline data at 6 weeks, follow up 6 months after study completion
will be captured via 10 point rating scale (1=not at all - 10= absolutely)
Changes from Baseline data at 6 weeks, follow up 6 months after study completion
Previous Experience with Yoga
Time Frame: Baseline sociodemographic data, captured at the beginning
dichotomous response format (0=no, 1=yes)
Baseline sociodemographic data, captured at the beginning
Previous Experience with Mindful Self Compassion
Time Frame: Baseline sociodemographic data, captured at the beginning
dichotomous response format (0=no, 1=yes)
Baseline sociodemographic data, captured at the beginning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
pro mente REHA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Human-Friedrich Unterrainer, Priv.Doz., Universitätsklinik für Psychiatrie/Medizinische Univeristät Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECS 1392/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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