Mindful Self Compassion in Rehabilitation Inpatients

Meditation Clinical Trial

Official title:

Mindful Self Compassion in Rehabilitation Inpatients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578433
• Other study ID #: ECS 1392/2015
• Status: Completed
• Phase: N/A
• First received: October 9, 2015
• Last updated: January 9, 2017
• Start date: December 2015
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written consent for study participation

• age over 18

Exclusion Criteria:

• psychotic episode

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meditation
• Progressive Muscle Relaxation

Intervention

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
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.

Locations

Country	Name	City	State
Austria	Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin	Graz	Steiermark

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin	pro mente REHA

Country where clinical trial is conducted

Austria, 

References & Publications (8)

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. — View 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.

Blatt SJ. Representational structures in psychopathology. University of Rochester Press 6: 1-34, 1995

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. — View Citation

Foryflow AL. Integrating Yoga with Psychotherapy: A Complementary Treatment for Anxiety and Depression. Canadian Journal of Counselling and Psychotherapy 45: 132-150, 2011.

Neff KD. Development and validation of a scale to measure self-compassion. Self and Identity 2: 223-250, 1993.

Spitzer C, Hammer S, Löwe 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 S — View Citation

World Health Organization. Global Status Report on Non-Communicable Diseases. Geneva:WHO 2010, 2011.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic Data/ Age	Digits entry	Baseline sociodemographic data, follow up 6 months after study completion	No
Other	Sociodemographic Data/ Education	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	No
Other	Sociodemographic Data/ Diet	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	No
Other	Sociodemographic Data/ Weight and Height (BMI)	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	No
Other	Sociodemographic Data/ Confession	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	No
Other	Sociodemographic Data/ Diagnosis	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	No
Other	Sociodemographic Data/ Medication	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	No
Other	Sociodemographic Data/ Level of Perceived Stress	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	No
Other	Sociodemographic Data/ Previous Experience with Meditation	dichotomous response format (0=no, 1=yes)	Baseline sociodemographic data	No
Other	Sociodemographic Data/ Previous Experience with Progressive Muscle Relaxation	dichotomous response format (0=no, 1=yes)	Baseline sociodemographic data	No
Other	Sociodemographic Data/ Previous Experience with Mindfulness	dichotomous response format (0=no, 1=yes)	Baseline sociodemographic data	No
Other	Sociodemographic Data/ Employment	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	No
Other	Sociodemographic Data/ Marital Status	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	No
Other	Sociodemographic Data/ Alcohol Consumption	dichotomous response format (0=no, 1=yes)	Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion	No
Other	Sociodemographic Data/ Drug Consumption	dichotomous response format (0=no, 1=yes)	Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion	No
Other	Sociodemographic Data/ Nicotine Consumption	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	No
Other	Sociodemographic Data/ Sympathy of the learned practice (either MSC or PMR)	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	No
Other	Sociodemographic Data/ Sympathy of the trainer (either MSC or PMR)	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	No
Other	Sociodemographic Data/ Duration of Practice	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	No
Other	Sociodemographic Data/ Frequency of Practice	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	No
Other	Sociodemographic Data/ Type of Practice	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	No
Other	Subjective Feeling of Health	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	No
Other	Subjective Feeling of Happines	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	No
Other	Previous Experience with Yoga	dichotomous response format (0=no, 1=yes)	Baseline sociodemographic data, captured at the beginning	No
Other	Previous Experience with Mindful Self Compassion	dichotomous response format (0=no, 1=yes)	Baseline sociodemographic data, captured at the beginning	No
Primary	Self-Compassion Scale (SCS)	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	No
Secondary	Brief Symptom Inventory (BSI-18)	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	No
Secondary	Health Survey (SF-36)	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	No