Mantra Meditation in Major Depression

NCT ID: NCT03004430

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-12

Study Completion Date

2020-07-30

Brief Summary

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To evaluate effects of mantra meditation on depressive symptoms if applied as adjunctive therapy to psychotherapy and/or antidepressant drugs and to explore if meditation leads to increased spirituality as a potential mediating factor of positive mental health.

Detailed Description

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Primary objective To measure the difference in efficacy between treatment as usual (TAU) + Mantra meditation (MAM) 20min per day and TAU + progressive muscle relaxation (PMR) 20min per day in the treatment of depressive symptoms in patients with Major Depression after inpatient treatment, after 3 months and after 6 months of treatment as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS).

Secondary objectives (exploratory)

1. Differences between and within groups in self-rated depression, rumination, automatic negative thinking or trait-anxiety.
2. Differences between and within groups in measures of spirituality.
3. Correlation between measures of spirituality and change of psychometric scores.
4. Change in stress response and relaxation response after inpatient treatment, compared to baseline.
5. Difference in adherence and depth of practice between groups and within groups and correlation to psychometric outcomes.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MAM

Mantra Meditation Group

Group Type EXPERIMENTAL

Mantra Meditation

Intervention Type BEHAVIORAL

Silent mantra meditation with spiritual mantra

PMR

Progressive Muscle Relaxation Group

Group Type ACTIVE_COMPARATOR

Progressive Muscle Relaxation

Intervention Type BEHAVIORAL

Progressive Muscle Relaxation

Interventions

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Mantra Meditation

Silent mantra meditation with spiritual mantra

Intervention Type BEHAVIORAL

Progressive Muscle Relaxation

Progressive Muscle Relaxation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Inpatients of open psychiatric ward
2. Written informed consent by patients who are competent to consent to study participation
3. Diagnosis of current episode of major depression as defined by DSM-IV criteria and diagnosed via structured interview (SKID) by a trained psychiatrist or psychologist. DSM-IV codes: 296.22, 296.23, 296.32, 296.33. Corresponding ICD-10 codes: F32.1, F32.2, F33.1, F33.2.
4. Male or female ≥18 years of age
5. BDI-II \>= 20
6. Patients must be able to sit in a chair for at least 20 minutes
7. Patients live in the catchment area of the hospital

Exclusion Criteria

Patients will be excluded for ANY ONE of the following reasons:

1. Any other current major psychiatric disorder is an exclusion criterion EXCEPT for the following:

* Abuse of nicotine or dependence of nicotine;
* Agoraphobia with or without Panic Disorder, Generalized Anxiety Disorder, Posttraumatic Stress Disorder, Specific Phobia, Social Phobia
* Hypochondriasis, Pain Disorder, Somatization Disorder, Undifferentiated Somatoform Disorder
* Sexual and Gender Identity Disorders
* Eating disorders
2. Psychotic symptoms that are not compatible with diagnosis of unipolar depression
3. Acute suicidality
4. Diagnosis affecting cortisol levels such as type I diabetes mellitus, cancer, asthma, chronic hepatitis, chronic fatigue syndrome, or regular use of medications having an immuno-modulary effect (e.g. cytotoxic chemotherapy, corticosteroids, interferons);
5. Current practice of other forms of Mantra repetition such as the rosary, chanting, or Transcendental Meditation
6. Current participation in another trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Dresden

OTHER

Sponsor Role collaborator

Diakonie Kliniken Zschadraß

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Holger C Bringmann, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Diakoniekliniken Zschadraß

Locations

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Diakoniekliniken Zschadraß

Colditz, Saxony, Germany

Site Status

Countries

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Germany

References

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Ospina MB, Bond K, Karkhaneh M, Tjosvold L, Vandermeer B, Liang Y, Bialy L, Hooton N, Buscemi N, Dryden DM, Klassen TP. Meditation practices for health: state of the research. Evid Rep Technol Assess (Full Rep). 2007 Jun;(155):1-263.

Reference Type RESULT
PMID: 17764203 (View on PubMed)

Ospina MB, Bond K, Karkhaneh M, Buscemi N, Dryden DM, Barnes V, Carlson LE, Dusek JA, Shannahoff-Khalsa D. Clinical trials of meditation practices in health care: characteristics and quality. J Altern Complement Med. 2008 Dec;14(10):1199-213. doi: 10.1089/acm.2008.0307.

Reference Type RESULT
PMID: 19123875 (View on PubMed)

Goyal M, Bass EB, Haythornthwaite JA. Meditation intervention reviews--reply. JAMA Intern Med. 2014 Jul;174(7):1195. doi: 10.1001/jamainternmed.2014.1393. No abstract available.

Reference Type RESULT
PMID: 25003880 (View on PubMed)

Other Identifiers

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MAMED001

Identifier Type: -

Identifier Source: org_study_id

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