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Trial record 19 of 36 for:    complementary and alternative medicine AND Survey

Mindful Self Compassion in Rehabilitation Inpatients

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ClinicalTrials.gov Identifier: NCT02578433
Recruitment Status : Completed
First Posted : October 19, 2015
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
pro mente REHA
Information provided by (Responsible Party):
Mag. Lisza Gaiswinkler, Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Meditation Progressive Muscle Relaxation Behavioral: Mindful Self Compassion Behavioral: Progressive Muscle Relaxation Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindful Self Compassion in Rehabilitation Inpatients: a Randomized Controlled Trial
Study Start Date : December 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written consent for study participation
  • age over 18

Exclusion Criteria:

  • psychotic episode

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578433


Locations
Austria
Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
Graz, Steiermark, Austria, 8036
Sponsors and Collaborators
Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
pro mente REHA
Investigators
Principal Investigator: Human-Friedrich Unterrainer, Priv.Doz. Universitätsklinik für Psychiatrie/Medizinische Univeristät Graz

Publications of Results:
Other Publications:
Barnett JE, Shale AJ. The Integration of Complementary and Alternative Medicine (CAM) into the Practice of Psychology: A Vision for the Future. Professional Psychology. Resarch and Practice 43: 576-585, 2012.
Foryflow AL. Integrating Yoga with Psychotherapy: A Complementary Treatment for Anxiety and Depression. Canadian Journal of Counselling and Psychotherapy 45: 132-150, 2011.
World Health Organization. Global Status Report on Non-Communicable Diseases. Geneva:WHO 2010, 2011.
Blatt SJ. Representational structures in psychopathology. University of Rochester Press 6: 1-34, 1995

Responsible Party: Mag. Lisza Gaiswinkler, Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
ClinicalTrials.gov Identifier: NCT02578433     History of Changes
Other Study ID Numbers: ECS 1392/2015
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mag. Lisza Gaiswinkler, Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin:
Mindful Self Compassion short form
Progressive Muscle Relaxation