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Mantra Meditation in Major Depression (MAMED)

D

Diakonie Kliniken Zschadraß

Status

Terminated

Conditions

Depression

Treatments

Behavioral: Mantra Meditation
Behavioral: Progressive Muscle Relaxation

Study type

Interventional

Funder types

Other

Identifiers

NCT03004430
MAMED001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

123 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

123 participants in 2 patient groups

MAM
Experimental group
Description:
Mantra Meditation Group
Treatment:
Behavioral: Mantra Meditation
PMR
Active Comparator group
Description:
Progressive Muscle Relaxation Group
Treatment:
Behavioral: Progressive Muscle Relaxation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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