Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-01-09 @ 6:54 PM
Study NCT ID:
NCT04089618
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2019-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meditation Based Lifestyle Modification in Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Case Research (SCR), also known as single case experimenal design (SCED). This is a reserach methodology using a single unit of analysis and characterized by repeated measures over time.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2019-09-07', 'studyFirstSubmitQcDate': '2019-09-12', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'at week 0 and week 11', 'description': 'WHOQol-BREF'}, {'measure': 'Chronic Pain Self-Efficacy', 'timeFrame': 'at week 0 and week 11', 'description': 'CPSS (Anderson et al, 1995)'}, {'measure': 'Distress Tolerance', 'timeFrame': 'at week 0 and week 11', 'description': 'Distress tolerance (Simons \\& Gaher, 2005)'}, {'measure': 'Spiritual and Religious Attitudes in Dealing with Illness', 'timeFrame': 'at week 0 and week 11', 'description': 'SpREUK (Büssing A., 2010)'}, {'measure': 'Trigunas - Emotion, Cognition and Health Behaviour', 'timeFrame': 'at week 0 and week 11', 'description': 'TGS Subscales (Puta \\& Sedlmeier, 2014)'}, {'measure': 'Illness Cognition', 'timeFrame': 'at week 0 and week 11', 'description': 'Illness Cognition Questionnaire for Chronic Diseases (Evers et al., 2001)'}], 'primaryOutcomes': [{'measure': 'Pain VAS', 'timeFrame': 'through study completion, daily for around 3 months', 'description': 'Visual Analog Scale for Pain'}, {'measure': 'Pain medication', 'timeFrame': 'through study completion, daily for around 3 months', 'description': 'Use of pain medication'}, {'measure': 'Well-Being', 'timeFrame': 'through study completion, daily for around 3 months', 'description': 'The WHO-5 Well-Being Scale (WHO-5; World Health Organisation, 1998)'}], 'secondaryOutcomes': [{'measure': 'Emotion Regulation', 'timeFrame': 'through study completion, weekly for around 3 months', 'description': 'Difficulties in Emotion Regulation Scale (DERS; Gratz \\& Roemer, 2003)'}, {'measure': 'Body awareness', 'timeFrame': 'through study completion, twice weekly for around 3 months', 'description': '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)'}, {'measure': 'Mind-Wandering', 'timeFrame': 'through study completion, weekly for around 3 months', 'description': 'a) Mind-Wandering Questionnaire (MWQ; Mrazek, Phillips, Franklin, Broadway, \\& Schooler, 2013)'}, {'measure': 'Depression, Anxiety & Stress', 'timeFrame': 'through study completion, weekly for around 3 months', 'description': 'DASS (Nilges \\& Essau, 2015)'}, {'measure': 'Pain Self Efficacy', 'timeFrame': 'through study completion, weekly for around 3 months', 'description': 'PAIN SELF EFFICACY QUESTIONNAIRE (PSEQ) M.K.Nicholas (1989)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Yoga', 'Meditation', 'Yoga Philosophy', 'Mantra', 'Mind-Body'], 'conditions': ['Pain, Chronic']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe study will be conducted as an experimental single case analysis with multiple baseline design. Randomization takes place over time instead of control groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Outpatients\n2. Current diagnosis of a chronic pain disorder.\n3. Over 18 years old.\n4. Physically able to perform simple yoga postures and sit for 20 minutes.\n5. Have given your written consent to participate in the study.\n\nExclusion Criteria:\n\n1. Psychotic symptoms\n2. Acute suicidality\n3. obsessive-compulsive disorder\n4. Cerebro-organic diseases with clinically relevant symptoms\n5. Severe multimorbidity\n6. Current participation in another meditation or yoga study\n7. Regular meditation or yoga practice (\\> once a week in the last 6 months)'}, 'identificationModule': {'nctId': 'NCT04089618', 'acronym': 'MBLM-P', 'briefTitle': 'Meditation Based Lifestyle Modification in Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Diakonie Kliniken Zschadraß'}, 'officialTitle': 'Meditation Based Lifestyle Modification in Chronic Pain', 'orgStudyIdInfo': {'id': 'MBLM-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baseline 10 Days', 'description': '10 days baseline before intervention starts.', 'interventionNames': ['Behavioral: MBLM']}, {'type': 'EXPERIMENTAL', 'label': 'Baseline 17 Days', 'description': '17 days baseline before intervention starts.', 'interventionNames': ['Behavioral: MBLM']}, {'type': 'EXPERIMENTAL', 'label': 'Baseline 24 Days', 'description': '24 days baseline before intervention starts.', 'interventionNames': ['Behavioral: MBLM']}], 'interventions': [{'name': 'MBLM', 'type': 'BEHAVIORAL', 'description': 'Complex 8 week Mind-Body program.', 'armGroupLabels': ['Baseline 10 Days', 'Baseline 17 Days', 'Baseline 24 Days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04680', 'city': 'Colditz', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Diakoniekliniken Zschadraß', 'geoPoint': {'lat': 51.12821, 'lon': 12.80295}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diakonie Kliniken Zschadraß', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chemnitz University of Technology', 'class': 'OTHER'}, {'name': 'Technische Universität Dresden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Holger C. Bringmann', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}