Meditation Based Lifestyle Modification in Chronic Pain (MBLM-P)

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.

Study Overview

• Status: Completed
• Conditions: Pain, Chronic
• Intervention / Treatment: Behavioral: MBLM

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Sachsen
    • Colditz, Sachsen, Germany, 04680
      • Diakoniekliniken Zschadraß

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baseline 10 Days; 10 days baseline before intervention starts.	Behavioral: MBLM; Complex 8 week Mind-Body program.
Experimental: Baseline 17 Days; 17 days baseline before intervention starts.	Behavioral: MBLM; Complex 8 week Mind-Body program.
Experimental: Baseline 24 Days; 24 days baseline before intervention starts.	Behavioral: MBLM; Complex 8 week Mind-Body program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain VAS	Visual Analog Scale for Pain	through study completion, daily for around 3 months
Pain medication	Use of pain medication	through study completion, daily for around 3 months
Well-Being	The WHO-5 Well-Being Scale (WHO-5; World Health Organisation, 1998)	through study completion, daily for around 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion Regulation	Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2003)	through study completion, weekly for around 3 months
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
Mind-Wandering	a) Mind-Wandering Questionnaire (MWQ; Mrazek, Phillips, Franklin, Broadway, & Schooler, 2013)	through study completion, weekly for around 3 months
Depression, Anxiety & Stress	DASS (Nilges & Essau, 2015)	through study completion, weekly for around 3 months
Pain Self Efficacy	PAIN SELF EFFICACY QUESTIONNAIRE (PSEQ) M.K.Nicholas (1989)	through study completion, weekly for around 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	WHOQol-BREF	at week 0 and week 11
Chronic Pain Self-Efficacy	CPSS (Anderson et al, 1995)	at week 0 and week 11
Distress Tolerance	Distress tolerance (Simons & Gaher, 2005)	at week 0 and week 11
Spiritual and Religious Attitudes in Dealing with Illness	SpREUK (Büssing A., 2010)	at week 0 and week 11
Trigunas - Emotion, Cognition and Health Behaviour	TGS Subscales (Puta & Sedlmeier, 2014)	at week 0 and week 11
Illness Cognition	Illness Cognition Questionnaire for Chronic Diseases (Evers et al., 2001)	at week 0 and week 11

Collaborators and Investigators

• Sponsor: Diakonie Kliniken Zschadraß
• Collaborators: Technische Universität Dresden; Chemnitz University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: September 7, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Yoga; Meditation; Mind-Body; Mantra; Yoga Philosophy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: MBLM-P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No