Meditation-Based Lifestyle Modification in Mild-to-Moderate Depression: Outcomes and Moderation Effects of Spirituality

Abstract

Objective:

Understanding the relevance of religion or spirituality (R/S) in the treatment of mental disorders is central to clinical and academic psychiatry. In this secondary analysis, associations of R/S with depression were investigated with respect to a new second-generation mindfulness-based intervention, the Meditation-Based Lifestyle Modification (MBLM) program.

Methods:

Different aspects of spirituality, spiritual coping, and spiritual engagement were assessed in 81 patients with a diagnosis of mild-to-moderate depression. Treatment effects on R/S postscores and predictor and moderation effects of depression severity and stress change-scores were evaluated at 8 weeks (MBLM vs. CONTROL [drug continuation therapy] vs. TAU [inpatient treatment as usual]) and 6 months (TAU+MBLM vs. TAU).

Results:

At both time points, significant differences between MBLM versus TAU and CONTROL were found in a range of spiritual outcomes, most of them with a medium-to-large effect size and in favor of MBLM. Baseline interest in spirituality (p = 0.001) and baseline spiritual mind–body practice (p = 0.017) were identified as independent predictors of change in depression severity at 6 months. Moreover, moderation analyses found that patients reporting often/regular spiritual mind–body practice at 6 months did not benefit differently from TAU+MBLM versus TAU (p = 0.437) regarding their change in depression severity and stress, while those reporting no/seldom spiritual mind–body practice at 6 months benefited significantly worse from TAU than from TAU+MBLM (p = 0.002).

Conclusions:

Participation in the MBLM program resulted in significantly greater increases in spirituality in depressed patients than standard therapy. Interest in spirituality and engagement in spiritual mind–body practices at baseline were positive predictors of clinical outcome in both groups. Patients of any group who regularly performed spiritual mind–body practices benefited equally in terms of antidepressant outcomes, underlining the benefit of these practices within a general therapeutic framework.

ClinicalTrials.gov Identifier:

NCT03652220

Introduction

Historically, associations between religiosity or spirituality (R/S) and mental health were close and framed in prerational, for example, mythic or archaic, narratives. These were naturally challenged in the modern era of the Western culture, particularly by the development of empirical sciences. At the latest with the “diagnosis” of the neurologist Sigmund Freud (1856–1939), stating that religion was an obsessive neurosis of mankind, a clear separation of science and R/S became apparently manifest. This development practically precluded an integration of R/S into the academic psychotherapeutic setting during the last century. However, in recent decades, there has been a renewed and growing interest in the relationship between R/S and mental health.^1,2

The terms religion or spirituality lack a commonly agreed definition, and a comprehensive discussion of concurrent interpretations is beyond the scope of this article. However, the term spirituality usually refers to individual experiences, beliefs, and practices related to the transcendent, while the term religion emphasizes the institutional aspect of spirituality.^3,4 Theoretically, R/S comprises many, often multidimensional constructs of private or public practices, beliefs and coping strategies that may lead to health behaviors, social support, and direct physiological processes, which then may affect health in its physical, mental, social, and spiritual dimensions by a variety of underlying mechanisms.⁵ Despite the heterogeneity of the term R/S, it is also used in this article to allow for a broad scope in introducing and discussing existing literature. Furthermore, based on the outcomes employed in this study, the authors address which aspects of R/S are meant specifically.

Today, a large body of research demonstrates a positive relationship between R/S and mental health conditions, including dementia, suicide, stress-related disorders, depression, and substance abuse. However, many of these studies were cross-sectional, effect sizes were often weak or marginal, and also varied depending on the population studied.^6,7 Problematic R/S in terms of religious struggles and religiously based violence may also be associated with impaired mental health.⁸ The World Psychiatric Association clearly states in its Position Statement on Spirituality and Religion in Psychiatry the necessity of a consideration of R/S in its “relevance to the origins, understanding and treatment of psychiatric disorders” as “central to clinical and academic psychiatry.”⁹ Recent highest quality evidence and expert review also underline the spiritual needs of patients in serious illness and the benefits of spirituality in an array of mental (and physical) health outcomes.¹⁰

In a more detailed view of the association between R/S and clinical depression, various meta-analyses showed predominantly an inverse correlation between R/S and severity of depression and some studies also found positive effects with respect to recovery and incident of depression¹¹; the underlying data predominantly from cross-sectional surveys were complex given the large heterogeneity of populations and measures. Therefore, it is important to state that not all indicators of R/S were significantly related and also depended on the sample (e.g., depressed participants under severe life stress where more protected by R/S than others). More recent research also shows results from longitudinal studies. A systematic review based on 152 prospective studies¹² found that about half of these studies reported a significant relationship between measures of R/S and a better outcome of depressive symptoms over the course of time.

The rest of the studies found no significant effect (about 40%) or a negative association with depression over time (about 10%). The estimated effect of R/S on depressive symptoms was considered small (d = −0.18); interestingly, studies with populations where the individuals were diagnosed with a mental disorder were more likely to show that R/S predicts an improvement of depression over the course of time (d = −0.37). However, the transferability of study results from the United States to Europe remains questionable, as Western Europe is more secular and studies report a less systematic association between R/S and depression.¹²

Meditation-Based Lifestyle Modification (MBLM)¹³ is a second-generation mind–body intervention,¹⁴ developed within a psychotherapeutic context for the treatment of stress-associated disorders. The intervention combines spiritual mantra meditation¹⁵ with body-oriented yoga exercises¹⁶ and ethical principles of life (e.g., nonviolence, truthfulness, contentment) derived from the yamas and niyamas (restraints and observances) mentioned in the Yoga Sutras of Patanjali,¹⁷ as both yoga/meditation practice and ethical lifestyle habits are positively correlated with R/S.^18,19 A distinctive feature of MBLM is the emphasis on ethical principles as a foundation for physical and mental practice. These principles are addressed in a group therapy context, applied through ongoing mindfulness practices and integrated into daily activities. First results of MBLM indicated a high efficacy in the treatment of moderate depression in comparison with guideline treatment and drug continuation therapy.^20,21

In this secondary analysis of the MBLM study,²¹ the authors were interested in patterns and associations of R/S with depression and raised the following questions: (1) How do R/S variables change over the time as a result of participation in the MBLM program in comparison with the control groups? (2) Are there baseline R/S variables that can be identified as independent predictors of clinical treatment response? (3) Are there post-R/S variables that moderate the change in clinical treatment response?

Methods

Design

The MBLM-D study (ClinicalTrials.gov Identifier: NCT03652220, Ethics Review Board of University of Chemnitz University of Technology Identifier: V-276-15-PS-MBLM-D-14062018) was a three-arm, single-site, randomized controlled trial conducted at the Clinic for Psychiatry, Psychosomatics, and Psychotherapy, Zschadraß, Germany, from August 2018 through June 2020. During the first 8 weeks (phase I), patients participated in the MBLM program (MBLM), received treatment as usual (TAU; individually tailored multimodal therapy based on the national guidelines for the treatment of unipolar depression), or received no further treatment (CONTROL; drug continuation therapy). Before the following 16 weeks (phase II), these three groups were streamlined to two groups (TAU and TAU+MBLM), allowing to distinguish participants after 6 months who had received either TAU-only or TAU+MBLM. For details, refer to the methods section of the main publication.²¹

Participants

In the MBLM-D study, adult psychiatric outpatients who had been diagnosed with mild-or-moderate depression according to the International Classification of Diseases, 10th Edition (ICD-10) criteria were recruited. N = 81 participants were allocated to three groups of same size (n = 27). There was one dropout during phase I in the MBLM group and three dropouts during phase II in the TAU group. For details, refer to the main publication.²¹

Outcome measures

Data were assessed at baseline before the intervention, after 8 weeks, and after 6 months. Variables for treatment response, relevant for this analysis, included depression severity using the Beck Depression Inventory (BDI)-II²² and perceived stress by the Perceived Stress Scale 10 (PSS-10),²³ which are both well-validated and widely used self-rated assessment tools for stress-associated disorders.

Interest in spirituality was measured only at baseline using a 5-point scaled question “How strong is your interest in spiritual/religious topics in general?”—very low, low, medium, large, or very large.

The aspects of spirituality (ASP) questionnaire was developed for use in health care research to measure a broad variety of vital ASP. A strength of the reliable and valid instrument is the operationalization also of nonformal ASP in terms of relational consciousness, particularly secular humanism and existential awareness. The 25 items of the ASP are scored on a 5-point scale (0—does not apply at all; 1—does not apply; 2—I don't know (neither yes or no); 3—applies quite well; 4—definitely applies) and are differentiated in 4 factors, that is, Religious Orientation, Search for Insight/Wisdom, Conscious Interactions, and Transcendence Conviction.²⁴

The Spiritual and Religious Attitudes in Dealing with Illness (SpREUK) questionnaire was developed for research and clinical use to investigate on spirituality as a resource to cope with chronic illness. The instrument avoids exclusive religious terminology and is therefore suited both in secular and also in religious populations. The 15 items of the SpREUK are scored on a 5-point scale (0—does not apply at all; 1—does not apply; 2—I don't know (neither yes or no); 3—applies quite well; 4—definitely applies) and are differentiated in 3 factors, that is, Search (for Support/Access), Trust (in Higher Guidance/Source), and Reflection (Positive Interpretation of Disease).²⁵ The SpREUK-P questionnaire was developed to measure the engagement of a broad spectrum of organized and private religious, spiritual, existential, and philosophical practices, avoiding the intermingling of attitudes, convictions associated with these behaviors. Again, the instrument is applicable both in secular and religious populations.

The SpREUK-P has 24 items scored on a 4-point scale (0—never; 1—seldom; 2—often; 3—regularly) and 5 factors, that is, Religious, Prosocial, Existentialistic, Spiritual mind–body practices, and Gratitude/Awe.²⁶

In summary, the three instruments mentioned above address different levels of spirituality: generic attitudes and convictions (ASP), specific attitudes and convictions in terms of coping (SpREUK-15), and generic practices (SpREUK-P).

All ASP, SpREUK, and SpREUK-P factor scores were transformed to a 100% level reflecting the degree of distinct forms of spirituality, with scores >50% indicating higher spirituality, while scores <50% indicate rare spirituality.^24
–26

Data analysis

To compare the effectiveness of interventions on secondary outcomes of R/S, a repeated-measures analysis of covariance (ANCOVA) was conducted to analyze time by group interactions. For the 8-week outcomes (T₀ vs. T₂), three groups were available for analysis (CONTROL vs. TAU vs. MBLM). For the 6-month outcomes (T₀ vs. T₃), two groups were available (TAU vs. TAU+MBLM). ANCOVAs were baseline adjusted.²⁷ Before the analysis, the authors made sure that the specific assumptions for normality and homogeneity of variance for the ANCOVA were met. They report exploratory p-values and corresponding partial eta² or Cohen's d as effect sizes. Post hoc t-tests were performed for the treatment contrasts of interest, with the respective p-values and Cohen's d reported as effect sizes. Bonferroni–Holm correction was used when appropriate. R 4.1 was used for descriptive analyses and ANCOVA.

Stepwise linear regression models were calculated using SPSS (release 27.0; IBM) to identify independent baseline values that might predict treatment response on BDI-II and PSS-10 severity (both of which showed significant differences in favor of the MBLM group at 8 weeks and 6 months after randomization²¹). The corrected R ² (the proportion of the variance of the treatment response that is explained by independent variables) was then used to calculate the effect size f ² with f ² = 0.20, 0.15, 0.35 corresponding to a small, medium, and large effect, respectively.²⁸

Moderation analyses were executed to identify variables of spirituality (W) that moderate the effect of treatment allocation at week 8 and month 6 (X) on the change in treatment response on BDI-II and PSS-10 severity (Y) using PROCESS (release 2.5.2) macro for SPSS (release 27.0; IBM) with bootstrapping of 5000 samples and 95% confidence intervals (CIs). PROCESS tests Y as a linear function of: Ŷ = constant + (b ₁ + b ₃ W)X + b ₂ W. If the effect of X on Y varies with W, b ₃ has to be significantly different from zero.

All analyses were considered exploratory with p-values <0.05 being set as significant. All results were based on the intention-to-treat population. Missing values were imputed using the multivariate imputations by the chained equation algorithm.²⁹ No constraints were placed on the range of values of the imputed results. Data supporting the results of this study are available from the corresponding author upon reasonable request.

Results

Descriptive analysis

Of 152 eligible patients, 81 were randomized to the 3 study phase I groups (Fig. 1). Of these, 80 were randomized to the 2 study arms in phase II. Of these, 77 completed the 6-month follow-up. Selected demographic and clinical characteristics at baseline are displayed in Table 1. Further descriptive results and dropout analysis are reported in the main publication.²¹ For variables of interest in this analysis, 3.2% of all questionnaire items were missing completely at random (little is missing completely at random test, p > 0.05) and were imputed before analysis.

FIG. 1.

Participant flow in a two-phase MBLM program in mild-to-moderate depression (modified according to 21). BDI-II, Beck Depression Inventory II; CONTROL, drug continuation therapy; MBLM, Meditation-Based Lifestyle Modification; TAU, treatment as usual.

Table 1.

Demographic and Clinical Baseline Characteristics of Study Participants of a Meditation-Based Lifestyle Modification Program in Mild-to-Moderate Depression, Stratified by Group; n (%), if Not Otherwise Specified

Label	Levels	Groups
Label	Levels	MBLM	CONTROL	TAU
Age	Mean (SD)	49.1 (11.1)	51.0 (12.7)	45.0 (11.1)
Gender	Female	21 (77.8)	21 (77.8)	23 (85.2)
Gender	Male	6 (22.2)	6 (22.2)	4 (14.8)
Marital status	Unmarried	2 (7.4)	5 (18.5)	7 (25.9)
	Divorced	4 (14.8)	5 (18.5)	3 (11.1)
	Married	20 (74.1)	14 (51.9)	17 (63.0)
	Widowed	1 (3.7)	3 (11.1)	0 (0.0)
Denomination	Catholic	1 (3.7)	0 (0.0)	0 (0.0)
	Protestant	7 (25.9)	11 (40.7)	5 (18.5)
	None	17 (63.0)	14 (51.9)	21 (77.8)
	Other	1 (3.7)	0 (0.0)	1 (3.7)
Depression type	First episode	10 (37.0)	11 (40.7)	10 (37.0)
Depression type	Recurrent episodes	17 (63.0)	16 (59.3)	17 (63.0)
Years since first episode	Mean (SD)	6.4 (7.9)	8.2 (8.1)	10.1 (8.5)
ACE 4	No	19 (73.1)	19 (76.0)	17 (73.9)
ACE 4	Yes	7 (26.9)	6 (24.0)	6 (26.1)
Months of psychotherapy	Mean (SD)	25.1 (27.0)	24.1 (29.1)	30.4 (29.7)

Table adopted from the main publication.²¹

ACE, adverse childhood events; CONTROL, drug continuation therapy; MBLM, Meditation-Based Lifestyle Modification; SD, standard deviation; TAU, treatment as usual.

Treatment effects on spirituality at 8 weeks

Over the course of the first 8 weeks, significant differences between the groups MBLM, TAU, and CONTROL were evident in a number of outcomes in favor of the MBLM group. In terms of generic attitudes and convictions (ASP), a medium-to-large effect size was found Religious Orientation and a small-to-medium effect size for Transcendence Conviction. As a specific attitude in terms of coping (SpREUK), a small-to-medium effect size was found for Search for Support. The largest difference were found in generic practices (SpREUK-P) with a large effect size for Spiritual (mind–body) Practices and medium-to-large effect sizes for Existentialistic Practices and Gratitude/Awe. In the remaining subscales, the MBLM group showed a nonsignificant increase of scores. Further details can be found in Table 2.

Table 2.

Postintervention Effects of a Meditation-Based Lifestyle Modification Program in Mild-to-Moderate Depression on Secondary Outcomes at 8 Weeks; Mean (Standard Deviation), Intention-to-Treat Population (N = 81)

Outcome	Subscale	Group	Baseline (T ₀)	8 Weeks (T ₂)	p	η² _p
ASP		CONTROL	52.5 (13.5)	52.5 (12.9)	<0.001^*	0.115
		TAU	51.7 (14.1)	52.5 (14.8)
		MBLM	51.7 (16.3)	62.0 (14.0)
	Religious Orientation	CONTROL	33.0 (22.5)	36.1 (21.9)	<0.001^*	0.107
		TAU	31.1 (21.7)	34.8 (24.2)
		MBLM	29.2 (26.3)	46.0 (24.1)
	Search for Insight/Wisdom	CONTROL	58.6 (16.2)	56.0 (14.3)	0.081	0.031
		TAU	61.7 (16.6)	60.5 (18.0)
		MBLM	64.5 (17.5)	69.6 (13.9)
	Conscious Interactions	CONTROL	75.7 (12.5)	67.4 (12.8)	0.137	0.025
		TAU	74.5 (13.0)	72.7 (11.1)
		MBLM	73.1 (15.1)	80.8 (11.5)
	Transcendence Conviction	CONTROL	54.0 (21.2)	51.9 (23.5)	0.026^*	0.046
		TAU	49.4 (24.1)	50.9 (23.5)
		MBLM	49.7 (32.1)	59.3 (25.0)
SpREUK		CONTROL	49.1 (19.2)	47.6 (19.3)	0.070	0.034
		TAU	52.2 (15.1)	50.9 (16.5)
		MBLM	52.7 (19.0)	57.8 (17.4)
	Search (for support/access)	CONTROL	44.1 (23.5)	40.9 (25.0)	0.037^*	0.042
		TAU	49.3 (19.8)	50.0 (21.7)
		MBLM	47.6 (24.7)	56.7 (23.6)
	Trust (in higher guidance/source)	CONTROL	44.8 (22.4)	45.4 (21.1)	0.166	0.023
		TAU	46.1 (16.3)	43.9 (16.6)
		MBLM	44.8 (22.6)	49.3 (20.0)
	Reflection (positive interpretation of disease)	CONTROL	58.5 (19.3)	56.5 (19.4)	0.436	0.016
		TAU	61.1 (18.6)	58.9 (19.7)
		MBLM	65.6 (18.2)	67.4 (16.9)
SpREUK-P	Religious	CONTROL	16.3 (14.5)	18.8 (16.1)	0.167	0.023
		TAU	14.5 (16.9)	17.0 (18.0)
		MBLM	19.4 (20.7)	27.1 (22.8)
	Prosocial	CONTROL	72.1 (15.0)	66.6 (17.7)	0.111	0.027
		TAU	64.8 (13.5)	63.5 (11.3)
		MBLM	70.3 (18.4)	72.1 (15.5)
	Existentialistic	CONTROL	55.9 (22.7)	55.9 (20.3)	<0.001^*	0.096
		TAU	58.8 (20.6)	59.6 (22.4)
		MBLM	60.0 (22.0)	74.8 (15.6)
	Spiritual (mind–body)	CONTROL	27.5 (22.9)	31.2 (23.7)	<0.001^*	0.446
		TAU	26.7 (15.5)	34.1 (18.2)
		MBLM	23.4 (20.5)	75.6 (16.9)
	Gratitude/Awe	CONTROL	41.9 (19.6)	41.5 (21.5)	<0.001^*	0.096
		TAU	43.6 (20.6)	45.6 (22.7)
		MBLM	41.1 (21.7)	58.0 (20.3)

Significance: “^*” 0.05.

η² _p, partial squared-eta for baseline-adjusted model; ASP, aspects of spirituality; MBLM, Meditation-Based Lifestyle Modification; SpREUK, spiritual coping; SpREUK-P, spiritual practices and engagement; TAU, treatment as usual.

In the post hoc analysis, patients who were in the MBLM group showed significantly higher scores in the majority of outcomes than patients in the CONTROL group and patients who received TAU. In terms of generic attitudes and convictions (ASP), large effect sizes were found for Religious Orientation and Search for Insight. As specific attitudes in terms of coping (SpREUK), a large effect size was found for Search for Support and a medium effect size for Positive Interpretation of Disease. The most prominent differences were found in generic practices (SpREUK-P) with large effect sizes for Spiritual (mind–body) Practices, Existentialistic Practices, Gratitude/Awe, and a medium effect for Religious Practices.

In the subscales, Transcendence Conviction (ASP), Search for Insight (ASP), and Prosocial Practices (SpREUK-P), the MBLM group only achieved higher scores than the CONTROL group, but not the TAU group. In the subscale Trust in Higher Guidance (SpREUK), the MBLM group only scored higher than the TAU group due to a relative strength of that feature in the CONTROL group. Further details are reported in Table 3.

Table 3.

Post Hoc Analyses at 8 Weeks, Intention-to-Treat Population of a Meditation-Based Lifestyle Modification Program in Mild-to-Moderate Depression (N = 81)

Outcome	Subscale	Contrast		d_c	p
ASP		CONTROL—TAU	−0.68	−0.10	0.712
		CONTROL—MBLM	−10.26	−1.54	<0.001^*
		TAU—MBLM	−9.58	−1.43	<0.001^*
	Religious Orientation	CONTROL—TAU	−0.73	−0.07	0.781
		CONTROL—MBLM	−13.66	−1.44	<0.001^*
		TAU—MBLM	−12.93	−1.37	<0.001^*
	Search for Insight/Wisdom	CONTROL—TAU	−2.07	−0.22	0.427
		CONTROL—MBLM	−9.02	−0.94	0.002^*
		TAU—MBLM	−6.94	−0.73	0.017^*
	Conscious Interactions	CONTROL—TAU	3.7	0.29	0.412
		CONTROL—MBLM	−4.4	−0.35	0.412
		TAU—MBLM	−8.1	−0.64	0.062
	Transcendence Conviction	CONTROL—TAU	−3.04	−0.27	0.331
		CONTROL—MBLM	−11.11	−0.98	0.001^*
		TAU—MBLM	−8.07	−0.71	0.021
SpREUK		CONTROL—TAU	−0.67	−0.08	0.770
		CONTROL—MBLM	−7.09	−0.84	0.007^*
		TAU—MBLM	−6.42	−0.76	0.011^*
	Search (for support/access)	CONTROL—TAU	−4.64	−0.37	0.176
		CONTROL—MBLM	−12.73	−1.02	<0.001^*
		TAU—MBLM	−8.09	−0.65	0.038^*
	Trust (in higher guidance/source)	CONTROL—TAU	2.60	0.28	0.298
		CONTROL—MBLM	−3.89	−0.43	0.239
		TAU—MBLM	−6.49	−6.49	0.030^*
	Reflection (positive interpretation of disease)	CONTROL—TAU	−0.15	−0.02	0.522
		CONTROL—MBLM	−4.80	−0.52	0.025^*
		TAU—MBLM	−4.65	−0.50	0.039^*
SpREUK-P	Religious	CONTROL—TAU	0.12	0.01	0.958
		CONTROL—MBLM	−5.44	−0.66	0.044^*
		TAU—MBLM	−5.56	−0.67	0.044^*
	Prosocial	CONTROL—TAU	−2.76	−0.30	0.274
		CONTROL—MBLM	−7.01	−0.77	0.016^*
		TAU—MBLM	−4.25	−0.46	0.183
	Existentialistic	CONTROL—TAU	−1.34	−0.13	0.643
		CONTROL—MBLM	−15.55	−1.45	<0.001^*
		TAU—MBLM	−14.20	−1.34	<0.001^*
	Spiritual (mind–body)	CONTROL—TAU	−3.51	−0.28	0.305
		CONTROL—MBLM	−47.58	−3.79	<0.001^*
		TAU—MBLM	−44.07	−3.51	<0.001^*
	Gratitude/Awe	CONTROL—TAU	−2.73	−0.23	0.403
		CONTROL—MBLM	−17.14	−1.43	<0.001^*
		TAU—MBLM	−14.41	−1.20	<0.001^*

Significance: “^*” 0.05.

ASP, aspects of spirituality; d_c , Cohen's d; MBLM, Meditation-Based Lifestyle Modification; SpREUK, spiritual coping; SpREUK-P, spiritual practices and engagement; TAU, treatment as usual.

Treatment effects on spirituality at 6 months

In this analysis, the authors contrasted patients who had received MBLM as a part of their treatment regimen within 6 months (TAU+MBLM) with patients who had received TAU. There were significant group differences in all subscales except for the general attitudes and convictions Search for Insight (ASP), Transcendence Conviction (ASP), and Prosocial Practices (SpREUK-P). All differences were in favor of patients who had participated in the MBLM program. In the post hoc analysis and in terms of generic attitudes and convictions (ASP), a large effect was found in Religious Orientation and a small-to-medium effect for Conscious Interactions. In terms of coping (SpREUK), a large effect was found in Trust in Higher Guidance and medium effects for Search for Support and Positive Interpretation of Disease.

Again, the most prominent differences were found in generic practices (SpREUK-P) with a large effect size for Spiritual (mind–body) Practices and Religious Practices and medium effects for Existentialistic Practices and Gratitude/Awe. Further details are reported in Table 4.

Table 4

Follow-Up Results at 6 Months; Mean (Standard Deviation), Intention-to-Treat Population of a Meditation-Based Lifestyle Modification Program in Mild-to-Moderate Depression (N = 81)

Outcome	Subscale	Group	Baseline (T ₀)	6 Months (T ₃)	p	η² _p		d_c	p
ASP		TAU	52.0 (15.2)	54.6 (15.1)	0.055	0.055	−6.42	−0.95	<0.001^*
		TAU+MBLM	51.9 (13.9)	61.0 (12.2)
	Religious Orientation	TAU	33.0 (24.0)	37.9 (25.3)	0.006^*	0.046	−9.83	−0.83	<0.001^*
		TAU+MBLM	29.4 (22.9)	44.5 (23.1)
	Search for Insight/Wisdom	TAU	59.3 (18.1)	61.5 (16.8)	0.388	0.005	−3.88	−0.39	0.081
	Search for Insight/Wisdom	TAU+MBLM	63.9 (15.1)	68.8 (13.0)
	Conscious Interactions	TAU	75.2 (13.1)	74.5 (14.0)	0.083	0.018	−5.8	−0.44	<0.001^*
	Conscious Interactions	TAU+MBLM	73.8 (13.9)	80.3 (11.2)
	Transcendence Conviction	TAU	50.8 (24.2)	35.5 (24.2)	0.331	0.006	−4.07	−0.31	0.128
	Transcendence Conviction	TAU+MBLM	51.2 (28.0)	57.9 (22.8)
SpREUK		TAU	50.2 (19.0)	50.5 (19.2)	0.016^*	0.037	−8.2	−0.81	<0.001^*
		TAU+MBLM	52.4 (16.5)	60.5 (15.8)
	Search (for support/access)	TAU	47.0 (23.2)	47.8 (25.6)	0.071	0.021	−9.12	−0.57	0.011^*
	Search (for support/access)	TAU+MBLM	47.0 (22.3)	56.8 (21.1)
	Trust (in higher guidance/source)	TAU	45.5 (21.1)	45.5 (20.7)	<0.001^*	0.058	−9.92	−0.97	<0.001^*
	Trust (in higher guidance/source)	TAU+MBLM	45.0 (19.9)	55.0 (18.3)
	Reflection (positive interpretation of disease)	TAU	58.1 (20.2)	58.4 (19.2)	0.196	0.011	−5.51	−0.53	0.019^*
	Reflection (positive interpretation of disease)	TAU+MBLM	65.2 (16.6)	69.8 (17.6)
SpREUK-P	Religious	TAU	16.4 (17.3)	17.1 (17.8)	0.013	0.038	−7.73	−0.79	<0.001^*
	Religious	TAU+MBLM	17.1 (17.8)	25.4 (23.0)
	Prosocial	TAU	66.8 (15.0)	68.1 (17.4)	0.802	0.000	−1.7	−0.17	0.444
	Prosocial	TAU+MBLM	71.3 (16.6)	73.3 (14.9)
	Existentialistic	TAU	55.5 (21.9)	56.6 (20.2)	0.105	0.017	−7.42	−0.61	0.007^*
	Existentialistic	TAU + MBLM	60.9 (21.2)	68.2 (19.0)
	Spiritual (mind–body)	TAU	29.1 (20.1)	31.6 (22.4)	<0.001^*	0.317	−41.4	−2.56	<0.001^*
	Spiritual (mind–body)	TAU+MBLM	22.7 (19.1)	68.8 (21.5)
	Gratitude/Awe	TAU	41.9 (21.3)	43.8 (22.1)	0.036^*	0.028	−8.73	−0.67	0.002^*
	Gratitude/Awe	TAU+MBLM	42.5 (19.8)	53.1 (20.7)

Significance: “^*” 0.05.

η² _p, partial squared-eta for baseline-adjusted model; ASP, aspects of spirituality; d_c : Cohen's d; DM, estimated difference of means at T₃; MBLM, Meditation-Based Lifestyle Modification; p, p-value (ANOVA, post hoc test); SpREUK, spiritual coping; SpREUK-P, spiritual practices and engagement; TAU, treatment as usual.

Regression effects

At week 8, no baseline variables could be found that significantly predict the change in BDI-II and PSS-10 severity.

At 6 months, two independent predictors could be identified that significantly explain 13.7% of the variance of the change in BDI-II severity (p = 0.001; f ² = 0.16). Included predictors are baseline interest in spirituality (p = 0.001) and baseline spiritual mind–body practice of the SpREUK-P (p = 0.017), while variables such as age, gender, and number of previous depressive episodes did not explain a significant proportion of the variance of the change in BDI-II. For the 6-month change in PSS-10, again no significant baseline predictors could be found.

Moderation effects

At week 8, no variables could be identified that moderated the effects of allocation to MBLM or TAU on change in BDI-II and PSS-10 severity.

At 6 months, moderation analyses of the factor spiritual mind-body practices of the SpREUK-P on the change in BDI-II revealed a significant moderation effect b ₃ = 15.51 (95% CI = 4.93–26.11; p = 0.005). Additional analysis of the conditional effects of treatment allocation on change in 6-month BDI-II severity found that patients reporting no/seldom (<50%) spiritual mind–body practice at 6 months benefit significantly worse from TAU than from TAU+MBLM (p = 0.002). Patients reporting often/regular (>50%) spiritual mind–body practice at 6 months did not benefit significantly different from TAU+MBLM or TAU (p = 0.437) (Fig. 2a). Comparable results were found for the moderation of the amount of spiritual mind–body practices at 6 months on the change in 6 months PSS-10 (b ₃ = 10.89, 95% CI = 3.31–18.48; p = 0.005), with significant conditional effects for patients with a lower amount (<50%) of self-reported spiritual mind–body practices (p = 0.002) and no significant conditional effects for patients with regular (>50%) spiritual mind–body practices (p = 0.852) (Fig. 2b).

FIG. 2.

Scatterplot. Conditional effects for patients with a low (<50%) and high (>50%) amount of self-reported spiritual mind–body practices on (a) the change in depression severity and (b) the change in stress perception, both at 6 months. BDI-II, Beck Depression Inventory II; MBLM, Meditation-Based Lifestyle Modification; PSS-10, Perceived Stress Scale 10; TAU, treatment as usual.

Discussion

In this analysis, secondary outcomes from the MBLM-D study were evaluated to examine the impact of the MBLM program on indicators of spirituality and its associations with clinical outcomes. The authors found that patients' participation in the MBLM program resulted in a significant increase in spirituality in most of the variables assessed compared with patients receiving standard treatment. This is consistent with Koenig's theoretical model of R/S and health, in which spiritual practice leads to a higher expression of spirituality associated measures and also positive mental health outcomes.³⁰ That being said, it seems also natural to assume a priori that a spiritual practice, by its very nature, entails more mindful social interaction and thus mental health, and so, cause and effect may not be clearly separated here.

Previous empirical findings also indicate that spiritual meditation, for example, may lead to positive changes in spiritual well-being—although these studies were carried out in different cultural and religious backgrounds (e.g., South Korea with a predominance of Buddhism and the United States with a predominance of Christianity) and findings might not easily be transferable to a more secular population in East Germany.^31
–33

In the domain of general attitudes and convictions (ASP), sustainable pre–post and group differences were found in the areas of Religious Orientation and Conscious Interactions. This is quite reasonable in the case of Conscious Interactions, since topics such as nonviolence and truthfulness represent central concerns of the yamas conveyed in MBLM and were also a central theme mentioned by the participants in the qualitative analysis.²⁰ With regard to Religious Orientation, the increase becomes more understandable if one considers the secular background of most of the participants and that presumably the meditation with spiritual mantras was also interpreted by the participants as a kind of prayer or R/S ritual.

In general practices (SpREUK-P), the largest difference was seen in the engagement in spiritual mind–body techniques. This is not surprising, as patients were generally able to establish a regular practice of yoga and meditation that continued up to 6 months.²¹ Also, religious practices increased over 6 months and in contrast to the TAU group. This is surprising, on the one hand, in view of the predominantly secular population in Eastern Germany and, on the other hand, in view of the fact that MBLM does not address formal religious practices in any way. Part of the instruction in mantra meditation, however, was the opportunity to meditate for oneself or others—thus there was an overlap in content with formal prayer. Existential practices and participants' ability to experience gratitude also increased. Consistent differences from standard therapy surfaced here, which were also supported by the qualitative results of the study.²⁰

There were no major differences in prosocial practices, either in the pre–post or in the group comparison, which may be attributed to high baseline levels.

In terms of coping (SpREUK), MBLM led to more search for support, trust in higher guidance, and positive reflection of disease after 6 months compared with the control groups. There is some evidence from mainly the U.S. populations that spirituality or religiosity can help people cope better with stressful life circumstances by providing meaning or contributing to social support during depression. However, effects were mostly small and R/S can also increase feelings of guilt and lead to discouragement.³⁴ In the U.S. general population, spiritual coping practices are used by only about 7% of depressed people³⁵—in Europe and Germany the percentage is likely to be even lower due to the more secular societies.

In the MBLM group, all participants were meditating (which could include the meaning of meditating for themselves or others) and about 25% of participants reported praying for themselves or others at the 6-month follow-up, in contrast to the beginning of the study. The authors therefore conclude from the results of this study that spiritual mind–body practices and MBLM in specific enhance the capacity for active coping. An underlying mechanism that may be proposed refers to the fear- and stress-reducing effects of practicing spiritual methods, which at all showed positive effects on mood.³⁶

Less relevant or no differences were evident in the areas of Search for Insight, Conscious Interactions, and Prosocial Practices at both 8 weeks and 6 months. The authors assume that these topics may be equally covered by standard psychotherapy, so that there were no substantial differences between the standard treatment and MBLM group.

Prior research has shown that spirituality may independently contribute to favorable treatment responses among depressed patients.³⁷ The present study extends this knowledge with findings that, in addition to interest in spirituality, it seems to be particularly important to actively practice spiritual mind–body methods. Patients in the TAU group who perform spiritual mind–body practices frequently or regularly do not differ significantly from frequently practicing patients in the MBLM group in terms of change on depression severity and stress. However, patients who never or rarely perform spiritual mind–body practices benefit significantly less from TAU than from MBLM.

This study is not without limitations, all of which are discussed in more detail in the main publication.²¹ First, the trial was addressed at depressed patients with an interest in yoga or meditation. Therefore, the results must be interpreted in the light of a possible selection bias. Second, all questionnaires used in this investigation were patient rated, which may have led to an introspective bias of unclear valence. Third, the aggregation of the three initial groups to two groups after 8 weeks, which was necessary for ethical reasons, may have diminished the external validity of the 6-month group comparisons.

Finally, the analysis did not distinguish between denominations. This could conceal effects in this regard. However, the authors assumed an essentially secular population in Eastern Germany with a rather historically grown denominational affiliation and considered nominal religiosity as less relevant than lived experience, so that they gave priority to the consideration of baseline spirituality as depicted in the questionnaires.

Conclusions

Participation in the MBLM program resulted in significantly greater increases in spirituality in depressed patients than standard therapy. Interest in spirituality and existing mind–body practices should be included in the psychological history given their positive predictive value. Patients who regularly performed spiritual mind–body practices benefited equally in terms of antidepressant therapy outcome, regardless of group assignment. In addition to the independent nature of MBLM as an antidepressant therapy, these results illustrate the benefit of spiritual mind–body practices within a general therapeutic framework.

Ethics Approval and Consent to Participate

Granted by the Ethics Review Board of University of Chemnitz University of Technology (V-276-15-PS-MBLM-D-14062018).

Availability of Data and Materials

The data that support the findings of this study are available on request from the corresponding author H.C.B. The data are not publicly available due to the sensitivity of human data that could compromise research participant privacy/consent.

Footnotes

Acknowledgments

The authors would like to thank the medical director Stefan Brunnhuber and chief physician Oliver Somburg for their friendly support for their study at the trial site.

Authors' Contributions

H.C.B. conceptualized and designed the study under the supervision of A.M. and S.B. S.B. supervised ethical and regulatory guidelines on the trial site. H.C.B., A.B., M.J., and H.H. contributed to statistical analysis and reporting. H.C.B. and H.H. wrote the first draft of the article. All authors approved the final version of the article.

Author Disclosure Statement

No competing financial interests exist.

Funding Information

This project was funded by the Karl and Veronica Carstens Foundation. The funding source has had no influence on trial methodology, implementation, analysis, and interpretation of data. Numbers KVC 0/098/2018.

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