NCT02578433

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

October 9, 2015

Last Update Submit

January 9, 2017

Conditions

MeditationProgressive Muscle Relaxation

Keywords

Mindful Self Compassion short formProgressive Muscle Relaxation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Brief Symptom Inventory (BSI-18)

    Change from Baseline values BSI-18 at 6 weeks, follow up 6 months after study completion

  • Health Survey (SF-36)

    Change from Baseline values in SF-36 at 6 weeks, follow up 6 months after study completion

Other Outcomes (25)

  • Sociodemographic Data/ Age

    Baseline sociodemographic data, follow up 6 months after study completion

  • Sociodemographic Data/ Education

    Baseline sociodemographic data, follow up 6 months after study completion

  • Sociodemographic Data/ Diet

    Changes from Baseline sociodemographic data at 6 weeks, follow up 6 months after study completion

  • +22 more other outcomes

Study Arms (2)

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

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

Behavioral: Progressive Muscle Relaxation

Interventions

Mindful Self CompassionBEHAVIORAL

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

Mindful Self Compassion
Progressive Muscle RelaxationBEHAVIORAL

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.

Progressive Muscle Relaxation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written consent for study participation
  • age over 18

You may not qualify if:

  • psychotic episode

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin

Graz, Styria, 8036, Austria

Location

Related 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. eCollection 2012.

    PMID: 23355825BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 8560303BACKGROUND

  • 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.

    PMID: 21870312RESULT

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

    RESULT

MeSH Terms

Interventions

Autogenic Training

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Human-Friedrich Unterrainer, Priv.Doz.

    Universitätsklinik für Psychiatrie/Medizinische Univeristät Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mag. Lisza Gaiswinkler

Study Record Dates

First Submitted

October 9, 2015

First Posted

October 19, 2015

Study Start

December 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 10, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)