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Completed

NCT Number: NCT02578433

Mindful Self Compassion in Rehabilitation Inpatients

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)

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Key information

Conditions

Meditation Progressive Muscle Relaxation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin

Graz, Styria, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written consent for study participation
  • age over 18

Exclusion criteria

  • psychotic episode

Treatment and study plan

Mindful Self Compassion

Behavioral

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

Progressive Muscle Relaxation

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

Other outcomes

  1. Sociodemographic Data/ Age

    Time frame: Baseline sociodemographic data, follow up 6 months after study completion

    Digits entry

  2. 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)

  3. 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)

  4. 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

  5. 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)

  6. 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

  7. 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

  8. 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)

  9. Sociodemographic Data/ Previous Experience with Meditation

    Time frame: Baseline sociodemographic data

    dichotomous response format (0=no, 1=yes)

  10. Sociodemographic Data/ Previous Experience with Progressive Muscle Relaxation

    Time frame: Baseline sociodemographic data

    dichotomous response format (0=no, 1=yes)

  11. Sociodemographic Data/ Previous Experience with Mindfulness

    Time frame: Baseline sociodemographic data

    dichotomous response format (0=no, 1=yes)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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

  17. 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)

  18. 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)

  19. 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)

  20. 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)

  21. 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

  22. 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)

  23. 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)

  24. Previous Experience with Yoga

    Time frame: Baseline sociodemographic data, captured at the beginning

    dichotomous response format (0=no, 1=yes)

  25. Previous Experience with Mindful Self Compassion

    Time frame: Baseline sociodemographic data, captured at the beginning

    dichotomous response format (0=no, 1=yes)

Sponsors and collaborators

Lead sponsor

Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin

Other

Collaborators

  • pro mente REHA

Registry information

Official study title

Mindful Self Compassion in Rehabilitation Inpatients: a Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2015
Registry last updated
Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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