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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04089618
Other study ID # MBLM-P
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2019
Est. completion date January 31, 2020

Study information

Verified date July 2020
Source Diakonie Kliniken Zschadraß
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

MBLM is a holistic therapy for people with mental disorders whose feasibility positive effects on patients with depression have already been demonstrated in clinical application and a piloted study. In the present trial, the feasibility and effect of MBLM on patients with chronic pain will be investigated.


Description:

MBLM expands existing concepts of mind-body medicine with ethical and spiritual concepts from the traditional Patanjali Yoga system, which can act as a coping factor on the one hand, and higher motivation and deepening of self-administered practice (mindfulness based exercises, body-oriented yoga exercises and mantra meditation). MBLM aims to establish an exercise routine in the daily lives of the participants, which leads to salutogenesis. The promotion of mental health through meditation and yoga has been well documented, also in clinical populations. The effects of meditation and yoga on addiction and pain are promising, but there is still a need for research. Furthermore, the preventive potential of the MBLM program will be examined for healthy volunteers, analogous to the already well-researched and widely used MBSR (Mindfulness Based Stress Reduction) program, which was originally also developed for patients with pain disorders.

The study will be conducted as an experimental single case analysis with multiple baseline design. Randomization takes place over time instead of control groups.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date January 31, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Outpatients

2. Current diagnosis of a chronic pain disorder.

3. Over 18 years old.

4. Physically able to perform simple yoga postures and sit for 20 minutes.

5. Have given your written consent to participate in the study.

Exclusion Criteria:

1. Psychotic symptoms

2. Acute suicidality

3. obsessive-compulsive disorder

4. Cerebro-organic diseases with clinically relevant symptoms

5. Severe multimorbidity

6. Current participation in another meditation or yoga study

7. Regular meditation or yoga practice (> once a week in the last 6 months)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MBLM
Complex 8 week Mind-Body program.

Locations

Country Name City State
Germany Diakoniekliniken Zschadraß Colditz Sachsen

Sponsors (3)

Lead Sponsor Collaborator
Diakonie Kliniken Zschadraß Chemnitz University of Technology, Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of Life WHOQol-BREF at week 0 and week 11
Other Chronic Pain Self-Efficacy CPSS (Anderson et al, 1995) at week 0 and week 11
Other Distress Tolerance Distress tolerance (Simons & Gaher, 2005) at week 0 and week 11
Other Spiritual and Religious Attitudes in Dealing with Illness SpREUK (Büssing A., 2010) at week 0 and week 11
Other Trigunas - Emotion, Cognition and Health Behaviour TGS Subscales (Puta & Sedlmeier, 2014) at week 0 and week 11
Other Illness Cognition Illness Cognition Questionnaire for Chronic Diseases (Evers et al., 2001) at week 0 and week 11
Primary Pain VAS Visual Analog Scale for Pain through study completion, daily for around 3 months
Primary Pain medication Use of pain medication through study completion, daily for around 3 months
Primary Well-Being The WHO-5 Well-Being Scale (WHO-5; World Health Organisation, 1998) through study completion, daily for around 3 months
Secondary Emotion Regulation Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2003) through study completion, weekly for around 3 months
Secondary Body awareness adapted from Private-Body-Consciousness-Scale (PBCS; Miller, Murphy, & Buss, 1981), Body-Awareness-Questionnaire" (BAQ; Shields, Mallory & Simon, 1989) and Multidimensional Assessment of Interoceptive Awareness" (MAIA; Mehling et al., 2012) through study completion, twice weekly for around 3 months
Secondary Mind-Wandering a) Mind-Wandering Questionnaire (MWQ; Mrazek, Phillips, Franklin, Broadway, & Schooler, 2013) through study completion, weekly for around 3 months
Secondary Depression, Anxiety & Stress DASS (Nilges & Essau, 2015) through study completion, weekly for around 3 months
Secondary Pain Self Efficacy PAIN SELF EFFICACY QUESTIONNAIRE (PSEQ) M.K.Nicholas (1989) through study completion, weekly for around 3 months
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