Clinical trial NCT03004430: Mantra Meditation in Major Depression
Official title: Mantra Meditation as Adjunctive Therapy in Major Depression: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Keywords: Mantra
Meditation
Lead sponsor: Diakonie Kliniken Zschadraß
Sponsor class: OTHER
Collaborators: name: University Hospital Dresden
First posted: 2016-12-28
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: MADRS / SIGMA
timeFrame: 6 months
Secondary outcomes:
measure: STAI-T
timeFrame: 6 months
measure: PTQ
timeFrame: 6 months
measure: RSQ
timeFrame: 6 months
measure: ASP
timeFrame: 6 months
measure: SpREUK
timeFrame: 6 months
measure: EEQ
timeFrame: 6 months
measure: ICPH
timeFrame: 6 months
measure: HRV
timeFrame: 1 month
Other outcomes:
Locations:
city: Colditz
country: Germany
facility: Diakoniekliniken Zschadraß
state: Sachsen
Study officials:
affiliation: Diakoniekliniken Zschadraß
name: Holger C Bringmann, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.