Mantra Meditation in Major Depression

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

Official Title
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Mantra Meditation as Adjunctive Therapy in Major Depression: a Randomized Controlled Trial

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Mantra Meditation
* Behavioral: Progressive Muscle Relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients will be excluded for ANY ONE of the following reasons: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAM<br>Mantra Meditation Group | Behavioral: Mantra Meditation<br>* Silent mantra meditation with spiritual mantra<br>|
| Active Comparator: PMR<br>Progressive Muscle Relaxation Group | Behavioral: Progressive Muscle Relaxation<br>* Progressive Muscle Relaxation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STAI-T | The State-Trait Anxiety Inventory (STAI) is an introspective psychological inventory consisting of 40 self-report items pertaining to anxiety affect. The STAI was constructed by Charles Spielberger, R.L. Gorsuch, and R.E. Lushene, based on the state-trait distinction proposed by Raymond Cattell in 1961. Their goal was to compile a set of items that could measure anxiety at both poles of the normal affect curve (state vs. trait). The STAI purports to measure one's conscious awareness at two extremes of anxiety affect, labeled state anxiety (A-state), and trait anxiety (A-trait), respectively. Affectivity ranges from immediate, transitory emotional states, through longer-lasting mood states, through dynamic motivational traits, ranging all the way up to relatively enduring personality traits. Higher STAI scores suggest higher levels of anxiety (C D Spielberger & Sydeman, 1994; Charles D Spielberger, 1987). | 6 months | 
| PTQ | The PTQ (Ehring et al., 2011) is a 15-item questionnaire assessing the tendency to engage in repetitive negative thinking independent of a disorder-specific content. Items are rated on a scale ranging from 0 (never) to 4 (almost always). The PTQ consists of three subscales: Core features of repetitive negative thinking, perceived unproductiveness of repetitive negative thinking , and repetitive negative thinking capturing mental capacity (sample item: 'My thoughts prevent me from focusing on other things'.). Confirmatory factor analysis provides support for a 3-factor solution. Assessment of the psychometric properties of the PTQ, including the Dutch version (Ehring, Raes, Weidacker, & Emmelkamp, 2012), has demonstrated high internal consistency (a = .93-.95), acceptable test-retest reliability (r = .69-.75), good convergent validity as well as good predictive validity in the prediction of symptom levels of anxiety and depression. | 6 months | 
| RSQ | The rumination scale of the Response Style Questionnaire (RSQ; Nolen-Hoeksema, 1991; German version: Kühner, Huffziger, & Nolen-Hoeksema, 2007) was used to assess repetitive negative thinking in the form of depressive rumination. The questionnaire consists of 22 items describing the individual's response to sad or depressed mood (e.g., Think about how passive and unmotivated you feel) that are rated on a scale from '1' (never) to '4' (always). The RSQ is regarded as the standard measure of rumination; it has been used widely in clinical as well as non-clinical populations and has demonstrated high reliability and validity (Kühner et al., 2007, Luminet, 2004 and Nolen-Hoeksema, 2004). | 6 months | 
| ASP | Aspects of Spirituality (ASP) . The ASP questionnaire was developed to measure a wide variety of vital aspects of spirituality beyond conventional conceptual boundaries in secular societies. Both expert representatives of various spiritual orientations and also atheists were asked which aspects of spirituality are relevant to them (Büssing, 2006). Identified motifs we condensed to 40 items of the Aspects of Spirituality (ASP 1.0) questionnaire (7 factors; Cronbach ́s alpha = .94) (Büssing et al., 2007) which differentiates and quantifies cognitive, emotional, intentional and action-oriented matters of theism/belief, (esoteric) transcendence, existentialism, humanism etc. The reliable and valid instrument is suited to be used in health care research (Büssing et al. 2007). | 6 months | 
| SpREUK | The SpREUK was developed to investigate whether or not patients with chronic diseases living in secular societies rely on spirituality as a resource to cope with illness. The SpREUK questionnaire relies on essential motifs found in counseling interviews with chronic disease patients (i.e., having trust/faith; search for a transcendent source to rely on; reflection of life and subsequent change of life and behavior). The instrument is suited to be used in health care research (A Büssing, Ostermann, & Matthiessen, 2005). | 6 months | 
| EEQ | A new instrument for the measurement of exceptional experiences, which considers both frequency and individual evaluation of exceptional experiences. A principal component factor analysis extracted four factors (positive spiritual experiences, experiences of deconstruction/ ego loss, psychopathological experiences and dream-type experiences), which explain 49% of the variance. The 25-item short form of the instrument shows good psychometric properties (range for Cronbach's alpha: r = 0.67-0.89, range for test- retest reliability after 6 months r = 0.66-0.87). The instrument shows adequate discriminant and convergent validity (Sense of Coherence, Social Support, Mental Distress and Transpersonal Trust) and can discriminate between spiritual practising and non practising individuals (Kohls & Walach, 2006). | 6 months | 
| ICPH | Specific mind-body-interventions (i.e., yoga, quigong, therapeutic eurythmy, mindfulness-based meditation etc.) require an active (emotional) engagement of individuals practicing it. Apart from direct physiological effects, an active emotional engagement seems to be important. This type of engagement can be conceptualized as an 'inner involvement ́ (Büssing et al. 2011). Lacking this attitude in terms of an inner resistance towards the practices may lead to reduced engagement, adherence, and thus treatment efficacy. The ICPH scale (Inner Correspondence / Peaceful Harmony with Practices) was developed to measure this 'inner correspondence in clinical studies addressing the efficacy of mind body practices involving physical movements. While it is suitable for progressive muscle relaxation, wording needs to be adjusted for mantra meditation (Arndt Büssing, Edelhuser, Weisskircher, Fouladbakhsh, & Heusser, 2011). | 6 months | 
| HRV | Change of Cardiovagal Index (CVI), a normalized measure of heart rate variability (HRV), in stress response and relaxation response after inpatient treatment. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mantra, Meditation