MeditationNCT02578433
Mindful Self Compassion in Rehabilitation Inpatients
A study testing Mindful Self Compassion and Progressive Muscle Relaxation in people with Meditation and Progressive Muscle Relaxation, run by Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meditation, Progressive Muscle Relaxation
- What is being tested?
- Mindful Self Compassion and Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written consent for study participation
- age over 18
Who cannot join
- psychotic episode
Trial locations and contacts
1 site in 1 country.
Austria1 site
Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
Graz, Styria, 8036
About this study
Official title: 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)
Read the 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.
- Conditions
- Meditation, Progressive Muscle Relaxation
- Being tested
- Mindful Self Compassion, Progressive Muscle Relaxation
- Keywords
- Mindful Self Compassion short form, Progressive Muscle Relaxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Self CompassionBehavioural
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 RelaxationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Self Compassion | Experimental | 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 Receives: Behavioral: Mindful Self Compassion |
| Progressive Muscle Relaxation | Other | 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 Receives: Behavioral: Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline values in SCS at 6 weeks, follow up 6 months after study completion
Secondary outcomes (2)
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.
Measured: Change from Baseline values BSI-18 at 6 weeks, follow up 6 months after study completion
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
Measured: Change from Baseline values in SF-36 at 6 weeks, follow up 6 months after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MeditationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
- Sponsor type
- University, hospital or other
- Collaborators
- pro mente REHA
- Responsible party
- Principal investigator, Mag. Lisza Gaiswinkler, Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
- Investigators
- Human-Friedrich Unterrainer, Priv.Doz., Principal investigator, Universitätsklinik für Psychiatrie/Medizinische Univeristät Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578433
- Sponsor's protocol ID
- ECS 1392/2015
- Status last verified
- Jan 2017
- First submitted
- 9 Oct 2015
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23355825Barnett 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
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.
PubMed 8560303Spitzer 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.
PubMed 21870312Neff KD. Development and validation of a scale to measure self-compassion. Self and Identity 2: 223-250, 1993.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Self Compassion in Rehabilitation Inpatients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02578433
- Acronym / sponsor ID
- ECS 1392/2015
- Conditions
- Meditation, Progressive Muscle Relaxation
- Keywords
- Mindful Self Compassion short form, Progressive Muscle Relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universitätsklinik für Psychiatrie und Psychotherapeutische MedizinUniversity, hospital or other
- Collaborators
- pro mente REHA
- Study start
- Dec 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Self Compassion | Experimental | Behavioral: Mindful Self CompassionParticipants 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 |
| Progressive Muscle Relaxation | Other | Behavioral: Progressive Muscle RelaxationParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written consent for study participation
- age over 18
Key exclusion criteria (1 listed)
- psychotic episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Self CompassionMindful 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 | Behavioural | Mindful Self Compassion |
| Progressive Muscle RelaxationProgressive 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. | Behavioural | Progressive Muscle Relaxation |
Primary outcome
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
2 secondary outcomes
Brief Symptom Inventory (BSI-18)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Background: PubMed 23355825Balasubramaniam 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.
- BackgroundBarnett 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.
- BackgroundForyflow AL. Integrating Yoga with Psychotherapy: A Complementary Treatment for Anxiety and Depression. Canadian Journal of Counselling and Psychotherapy 45: 132-150, 2011.
- BackgroundWorld Health Organization. Global Status Report on Non-Communicable Diseases. Geneva:WHO 2010, 2011.
- BackgroundBlatt SJ. Representational structures in psychopathology. University of Rochester Press 6: 1-34, 1995
- Background: PubMed 8560303Bullinger 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.
- Results publication: PubMed 21870312Spitzer 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.
- Results publicationNeff KD. Development and validation of a scale to measure self-compassion. Self and Identity 2: 223-250, 1993.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Human-Friedrich Unterrainer, Priv.Doz. principal investigator
Universitätsklinik für Psychiatrie/Medizinische Univeristät Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Self Compassion and Progressive Muscle Relaxation in people with Meditation and Progressive Muscle Relaxation, run by Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Compassion Scale (SCS) (time frame: Change from Baseline values in SCS at 6 weeks, follow up 6 months after study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02578433, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.