Study Results
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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TERMINATED
NA
123 participants
INTERVENTIONAL
2017-01-12
2020-07-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MAM
Mantra Meditation Group
Mantra Meditation
Silent mantra meditation with spiritual mantra
PMR
Progressive Muscle Relaxation Group
Progressive Muscle Relaxation
Progressive Muscle Relaxation
Interventions
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Mantra Meditation
Silent mantra meditation with spiritual mantra
Progressive Muscle Relaxation
Progressive Muscle Relaxation
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University Hospital Dresden
OTHER
Diakonie Kliniken Zschadraß
OTHER
Responsible Party
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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
Countries
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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.
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.
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.
Other Identifiers
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MAMED001
Identifier Type: -
Identifier Source: org_study_id
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