Clinical trial NCT02578433: Mindful Self Compassion in Rehabilitation Inpatients
Official title: Mindful Self Compassion in Rehabilitation Inpatients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meditation
Progressive Muscle Relaxation
Keywords: Mindful Self Compassion short form
Progressive Muscle Relaxation
Lead sponsor: Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
Sponsor class: OTHER
Collaborators: name: pro mente REHA
First posted: 2015-10-19
Enrollment: 200
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: 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)

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.

Eligibility criteria: Inclusion Criteria:

* Written consent for study participation
* age over 18

Exclusion Criteria:

* psychotic episode

Primary outcomes:
measure: Self-Compassion Scale (SCS)
timeFrame: Change from Baseline values in SCS at 6 weeks, follow up 6 months after study completion
Secondary outcomes:
measure: Brief Symptom Inventory (BSI-18)
timeFrame: Change from Baseline values BSI-18 at 6 weeks, follow up 6 months after study completion
measure: Health Survey (SF-36)
timeFrame: Change from Baseline values in SF-36 at 6 weeks, follow up 6 months after study completion
Other outcomes:
measure: Sociodemographic Data/ Age
timeFrame: Baseline sociodemographic data, follow up 6 months after study completion
measure: Sociodemographic Data/ Education
timeFrame: Baseline sociodemographic data, follow up 6 months after study completion
measure: Sociodemographic Data/ Diet
timeFrame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
measure: Sociodemographic Data/ Weight and Height (BMI)
timeFrame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
measure: Sociodemographic Data/ Confession
timeFrame: Baseline sociodemographic data, follow up 6 months after study completion
measure: Sociodemographic Data/ Diagnosis
timeFrame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
measure: Sociodemographic Data/ Medication
timeFrame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
measure: Sociodemographic Data/ Level of Perceived Stress
timeFrame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
measure: Sociodemographic Data/ Previous Experience with Meditation
timeFrame: Baseline sociodemographic data
measure: Sociodemographic Data/ Previous Experience with Progressive Muscle Relaxation
timeFrame: Baseline sociodemographic data
measure: Sociodemographic Data/ Previous Experience with Mindfulness
timeFrame: Baseline sociodemographic data
measure: Sociodemographic Data/ Employment
timeFrame: Baseline sociodemographic data, follow up 6 months after study completion
measure: Sociodemographic Data/ Marital Status
timeFrame: Baseline sociodemographic data, follow up 6 months after study completion
measure: Sociodemographic Data/ Alcohol Consumption
timeFrame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
measure: Sociodemographic Data/ Drug Consumption
timeFrame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
measure: Sociodemographic Data/ Nicotine Consumption
timeFrame: Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion
measure: Sociodemographic Data/ Sympathy of the learned practice (either MSC or PMR)
timeFrame: sociodemographic data at 6 weeks, follow up 6 months after study completion
measure: Sociodemographic Data/ Sympathy of the trainer (either MSC or PMR)
timeFrame: sociodemographic data at 6 weeks, follow up 6 months after study completion
measure: Sociodemographic Data/ Duration of Practice
timeFrame: sociodemographic data at 6 weeks, follow up 6 months after study completion
measure: Sociodemographic Data/ Frequency of Practice
timeFrame: sociodemographic data at 6 weeks, follow up 6 months after study completion
measure: Sociodemographic Data/ Type of Practice
timeFrame: sociodemographic data at 6 weeks, follow up 6 months after study completion
measure: Subjective Feeling of Health
timeFrame: Changes from Baseline data at 6 weeks, follow up 6 months after study completion
measure: Subjective Feeling of Happines
timeFrame: Changes from Baseline data at 6 weeks, follow up 6 months after study completion
measure: Previous Experience with Yoga
timeFrame: Baseline sociodemographic data, captured at the beginning
measure: Previous Experience with Mindful Self Compassion
timeFrame: Baseline sociodemographic data, captured at the beginning
Locations:
city: Graz
country: Austria
facility: Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
state: Steiermark
Study officials:
affiliation: Universitätsklinik für Psychiatrie/Medizinische Univeristät Graz
name: Human-Friedrich Unterrainer, Priv.Doz.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balasubramaniam M, Telles S, Doraiswamy PM. Yoga on our minds: a systematic review of yoga for neuropsychiatric disorders. Front Psychiatry. 2013 Jan 25;3:117. doi: 10.3389/fpsyt.2012.00117. eCollection 2012.
citation: 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.
citation: Foryflow AL. Integrating Yoga with Psychotherapy: A Complementary Treatment for Anxiety and Depression. Canadian Journal of Counselling and Psychotherapy 45: 132-150, 2011.
citation: World Health Organization. Global Status Report on Non-Communicable Diseases. Geneva:WHO 2010, 2011.
citation: Blatt SJ. Representational structures in psychopathology. University of Rochester Press 6: 1-34, 1995
citation: Bullinger M. German translation and psychometric testing of the SF-36 Health Survey: preliminary results from the IQOLA Project. International Quality of Life Assessment. Soc Sci Med. 1995 Nov;41(10):1359-66. doi: 10.1016/0277-9536(95)00115-n.
citation: Spitzer C, Hammer S, Lowe B, Grabe HJ, Barnow S, Rose M, Wingenfeld K, Freyberger HJ, Franke GH. [The short version of the Brief Symptom Inventory (BSI -18): preliminary psychometric properties of the German translation]. Fortschr Neurol Psychiatr. 2011 Sep;79(9):517-23. doi: 10.1055/s-0031-1281602. Epub 2011 Aug 25. German.
citation: Neff KD. Development and validation of a scale to measure self-compassion. Self and Identity 2: 223-250, 1993.