Mantra Meditation in Major Depression

NCT03004430 | Terminated

• 1 other identifier: MAMED001
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

Mantra; Meditation

Outcome Measures

Primary Outcomes (1)

• MADRS / SIGMA

  The clinician-rated Montgomery and Asberg Depression Rating Scale (MADRS) \[reproduced in the Appendix to this chapter\] was developed in the late 1970s (Montgomery \& Asberg, 1979) and this 10-item scale was designed to be sensitive to the effects of antidepressant medications, primarily tricyclic antidepressants. One of the original goals of the MADRS was to obtain an instrument that could be used by both psychiatrists and professionals without a specific or with minimal psychiatric training. From the original report of the MADRS, the inter-rater reliability ranged from 0.89 to 0.97. However, in a German study, significant differences resulted when the same patient was rated by various groups of caregivers (as described in Cusin, Yang, Yeung, \& Fava, 2010). Hence, a structured interview guide (SIGMA) that has been developed for the MADRS (Williams, Kobak, \& Montgomery, 2008) will be used in this study by trained psychologists exclusively.

  6 months

Secondary Outcomes (8)

• STAI-T

  6 months

• PTQ

  6 months

• RSQ

  6 months

• ASP

  6 months

• SpREUK

  6 months

Study Arms (2)

MAM

EXPERIMENTAL

Mantra Meditation Group

Behavioral: Mantra Meditation

PMR

ACTIVE COMPARATOR

Progressive Muscle Relaxation Group

Behavioral: Progressive Muscle Relaxation

Interventions

Mantra Meditation BEHAVIORAL

Silent mantra meditation with spiritual mantra

MAM

Progressive Muscle Relaxation BEHAVIORAL

Progressive Muscle Relaxation

PMR

Eligibility Criteria

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

You may qualify if:

• Inpatients of open psychiatric ward
• Written informed consent by patients who are competent to consent to study participation
• 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.
• Male or female ≥18 years of age
• BDI-II \>= 20
• Patients must be able to sit in a chair for at least 20 minutes
• Patients live in the catchment area of the hospital

You may not qualify if:

• Patients will be excluded for ANY ONE of the following reasons:
• 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
• Psychotic symptoms that are not compatible with diagnosis of unipolar depression
• Acute suicidality
• 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);
• Current practice of other forms of Mantra repetition such as the rosary, chanting, or Transcendental Meditation
• Current participation in another trial

Sponsors & Collaborators

• Diakonie Kliniken Zschadraß: lead
• University Hospital Dresden: collaborator

Study Sites (1)

Diakoniekliniken Zschadraß

Colditz, Saxony, 04680, Germany

Location

Related Publications (3)

• 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.

  PMID: 17764203 RESULT

• 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.

  PMID: 19123875 RESULT

• 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.

  PMID: 25003880 RESULT

MeSH Terms

Conditions

Depression

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Holger C Bringmann, Dr. med.

  Diakoniekliniken Zschadraß

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 28, 2016
• Study Start: January 12, 2017
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

DE (1)