Meditation Based Lifestyle Modification in Depression

NCT03652220 | Completed

• 1 other identifier: MBLM-D
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate effectiveness of a 8-week behavioral Mind-Body-Intervention based on Yoga and Meditation in depressive outpatients.

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change of Beck Depression Index BDI-II

  Change of depressive Symptoms

  Baseline, 4 weeks, 8 weeks. Follow-up 24 weeks

Secondary Outcomes (19)

• Freiburg Mindfulness Inventory (FMI)

  Baseline, 8 weeks; Follow-up 24 weeks

• Mindful Attention Awareness Scale (MAAS)

  Baseline, 8 weeks; Follow-up 24 weeks

• Perceived Stress Scale (PSS-10)

  Baseline, 8 weeks; Follow-up 24 weeks

• Brief Symptom Checklist (BSI-18)

  Baseline, 8 weeks; Follow-up 24 weeks

• Aachen Self-Efficacy Questionnaire (Aachener Selbstwirksamkeitsfragebogen, [ASF])

  Baseline, 8 weeks; Follow-up 24 weeks

Study Arms (3)

Intervention

EXPERIMENTAL

8 weeks Minimal treatment + MBLM 16 weeks Multimodal specific treatment + MBLM Consolidation Definitions Minimal treatment: drug continuation under medical supervision Multimodal specific treatment: Drugs / Psychotherapy / Excercise therapy / Ergotherapy / Relaxation; excl. Yoga, Mantra, MBSR MBLM: 8-week course Meditation Based Lifestyle Modification MBLM-Consolidation: weekly Mantra-Meditation, monthly Life-Ethics

Behavioral: Meditation Based Lifestyle Modification

Control I

ACTIVE COMPARATOR

8 weeks Minimal treatment 16 weeks Multimodal specific treatment Definitions Minimal treatment: drug continuation under medical supervision Multimodal specific treatment: Drugs / Psychotherapy / Excercise therapy / Ergotherapy / Relaxation; excl. Yoga, Mantra, MBSR MBLM: 8-week course Meditation Based Lifestyle Modification MBLM-Consolidation: weekly Mantra-Meditation, monthly Life-Ethics

Other: Minimal treatment; Other: Multimodal specific treatment:

Control 2

ACTIVE COMPARATOR

Definitions 24 weeks Multimodal specific treatment Minimal treatment: drug continuation under medical supervision Multimodal specific treatment: Drugs / Psychotherapy / Excercise therapy / Ergotherapy / Relaxation; excl. Yoga, Mantra, MBSR MBLM: 8-week course Meditation Based Lifestyle Modification MBLM-Consolidation: weekly Mantra-Meditation, monthly Life-Ethics

Other: Multimodal specific treatment:

Interventions

Meditation Based Lifestyle Modification BEHAVIORAL

8 weekly modules, each 3.5 hours of Life ethics, Yoga exercises and Mantra Meditation

Intervention

Minimal treatment OTHER

Drug continuation under medical supervision

Control I

Multimodal specific treatment: OTHER

Drugs / Psychotherapy / Excercise therapy / Ergotherapy / Relaxation; excl. Yoga, Mantra, MBSR

Control 2; Control I

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet the following criteria to be enrolled:
• Outpatients
• Written informed consent by patients who are competent to consent to study participation
• Diagnosis of current mild or moderate episode of depression diagnosed by a consultant psychiatrist
• Male or female ≥18 years of age
• BDI-II \>= 10
• Patients must be physically able to perform simple Yoga postures and to sit silently for 20 minutes

You may not qualify if:

• Patients will be excluded for ANY ONE of the following reasons:
• Psychotic Symptoms
• Acute suicidal tendencies
• Compulsive disorders
• Cerebro-organic diseases with clinically relevant symptoms
• Severe multimorbidity
• Clinically relevant addictions (tobacco abuse or addiction is allowed)
• Current participation in another trial

Sponsors & Collaborators

• Diakonie Kliniken Zschadraß: lead
• Charite University, Berlin, Germany: collaborator
• Chemnitz University of Technology: collaborator

Study Sites (1)

Diakoniekliniken Zschadraß

Colditz, Saxony, 04680, Germany

Location

Related Publications (2)

• Bringmann HC, Berghofer A, Jeitler M, Michalsen A, Brunnhuber S, Haller H. Meditation-Based Lifestyle Modification in Mild-to-Moderate Depression: Outcomes and Moderation Effects of Spirituality. J Integr Complement Med. 2024 Jun;30(6):532-542. doi: 10.1089/jicm.2023.0179. Epub 2023 Nov 27.

  PMID: 38011739 DERIVED

• Bringmann HC, Vennemann J, Gross J, Matko K, Sedlmeier P. "To Be Finally at Peace with Myself": A Qualitative Study Reflecting Experiences of the Meditation-Based Lifestyle Modification Program in Mild-to-Moderate Depression. J Altern Complement Med. 2021 Sep;27(9):786-795. doi: 10.1089/acm.2021.0038. Epub 2021 Jun 29.

  PMID: 34185550 DERIVED

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. B. Sc.

Model Details: This is a three-arm, randomized, active-controlled, unblinded, parallel, exploratory study to compare the outcome in depression between standard specific treatment, multimodal specific treatment and standard treatment plus MBLM. After being screened for eligibility and signing the informed consent patients will be randomized 1:1:1 to either one of the groups. After being enrolled, patients in MBLM group receive an introductory education of the MBLM course and then join group sessions weekly for 8 weeks. They also see a consultant psychiatrist as needed for drug continuation therapy. Patients should practice MBLM related content at home for a proposed duration of 30-45 minutes per day. Patients in the control groups receive standard (control group I) or multimodal (control group II) treatment as administered by their consultant psychiatrist.

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 29, 2018
• Study Start: August 27, 2018
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2020
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

DE (1)