Skip to main content
OpenTrials
Completed

NCT Number: NCT04089618

Meditation Based Lifestyle Modification in Chronic Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diakoniekliniken Zschadraß

Colditz, Saxony, 04680, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients
  • Current diagnosis of a chronic pain disorder.
  • Over 18 years old.
  • Physically able to perform simple yoga postures and sit for 20 minutes.
  • Have given your written consent to participate in the study.

Exclusion criteria

  • Psychotic symptoms
  • Acute suicidality
  • obsessive-compulsive disorder
  • Cerebro-organic diseases with clinically relevant symptoms
  • Severe multimorbidity
  • Current participation in another meditation or yoga study
  • Regular meditation or yoga practice (> once a week in the last 6 months)

Treatment and study plan

MBLM

Behavioral

Complex 8 week Mind-Body program.

Primary outcomes

  1. Pain VAS

    Time frame: through study completion, daily for around 3 months

    Visual Analog Scale for Pain

  2. Pain medication

    Time frame: through study completion, daily for around 3 months

    Use of pain medication

  3. Well-Being

    Time frame: through study completion, daily for around 3 months

    The WHO-5 Well-Being Scale (WHO-5; World Health Organisation, 1998)

Secondary outcomes

  1. Emotion Regulation

    Time frame: through study completion, weekly for around 3 months

    Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2003)

  2. Body awareness

    Time frame: through study completion, twice weekly for around 3 months

    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)

  3. Mind-Wandering

    Time frame: through study completion, weekly for around 3 months

    a) Mind-Wandering Questionnaire (MWQ; Mrazek, Phillips, Franklin, Broadway, & Schooler, 2013)

  4. Depression, Anxiety & Stress

    Time frame: through study completion, weekly for around 3 months

    DASS (Nilges & Essau, 2015)

  5. Pain Self Efficacy

    Time frame: through study completion, weekly for around 3 months

    PAIN SELF EFFICACY QUESTIONNAIRE (PSEQ) M.K.Nicholas (1989)

Other outcomes

  1. Quality of Life

    Time frame: at week 0 and week 11

    WHOQol-BREF

  2. Chronic Pain Self-Efficacy

    Time frame: at week 0 and week 11

    CPSS (Anderson et al, 1995)

  3. Distress Tolerance

    Time frame: at week 0 and week 11

    Distress tolerance (Simons & Gaher, 2005)

  4. Spiritual and Religious Attitudes in Dealing with Illness

    Time frame: at week 0 and week 11

    SpREUK (Büssing A., 2010)

  5. Trigunas - Emotion, Cognition and Health Behaviour

    Time frame: at week 0 and week 11

    TGS Subscales (Puta & Sedlmeier, 2014)

  6. Illness Cognition

    Time frame: at week 0 and week 11

    Illness Cognition Questionnaire for Chronic Diseases (Evers et al., 2001)

Sponsors and collaborators

Lead sponsor

Diakonie Kliniken Zschadraß

Other

Collaborators

  • Chemnitz University of Technology
  • Technische Universität Dresden

Registry information

Acronym: MBLM-P

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2019
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.