Efficacy of Heartfulness Meditation as Adjunctive Therapy for Moderate to Severe Psoriasis: A Randomised Controlled Trial

Abstract

Background:

Psoriasis is a chronic inflammatory skin condition significantly impacting quality of life. Traditional treatments, such as methotrexate, are effective but often have side effects and do not address psychosocial stressors. Heartfulness meditation, which emphasises relaxation and self-awareness, may complement standard treatments by reducing stress.

Objective:

The primary objective was to evaluate the effectiveness of heartfulness meditation as an adjunct to methotrexate in achieving a 75% reduction in Psoriasis Area and Severity Index (PASI 75) at 4 months. Secondary objectives included changes in body surface area (BSA), Dermatology Life Quality Index (DLQI), Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI), and biomarkers (serum cortisol and IL-6 levels).

Methods:

This randomised controlled trial was conducted at the dermatology outpatient department of the institute, India, involving 50 adults (18–60 years) with moderate to severe psoriasis (PASI ≥10 or BSA involvement ≥10%). Participants were randomised into two groups: the intervention group (n = 25) received heartfulness meditation alongside methotrexate (7.5 mg to 25 mg weekly), while the control group (n = 25) received methotrexate alone. Randomisation used a computer-generated sequence, with blinding applied to outcome assessors and data analysts.

Results:

Of the 50 participants randomised, 44 were included in the final analysis. PASI 75 was achieved in 61.1% of the intervention group compared to 52.38% in the control group (P = 0.548). Trends towards better improvements in BSA, DLQI, PSS, and PSQI were observed in the intervention group, though not statistically significant. Both groups showed reductions in serum cortisol and IL-6 levels, with slightly greater reductions in the intervention group. No adverse events related to heartfulness meditation were reported.

Conclusion:

Heartfulness meditation may offer additional benefits when combined with methotrexate for treating moderate to severe psoriasis, though findings were not statistically significant. Larger studies are needed to confirm these results.

Introduction

Psoriasis is a chronic inflammatory disease primarily affecting the skin and joints, with a prevalence of 0.2% to 4.8% in the general population.[1] While various treatment options exist, including phototherapy, cyclosporine, acitretin, methotrexate, and biologics, psoriasis often follows a chronic relapsing and remitting course.[2] Stress is a well-established aggravating factor for psoriasis, with studies reporting that patients experience symptom worsening during stressful periods.[3] This stress-psoriasis cycle can significantly impact a patient’s quality of life due to emotional distress, social anxiety, and sleep disturbances.[4,5]

The exploration of stress reduction strategies as complementary therapies for psoriasis management is gaining momentum. Meditation, a form of mind–body medicine, has shown promise in improving mental well-being and reducing stress in various populations.[6] A study by Kabat-Zinn et al.[7] demonstrated that mindfulness meditation, when combined with phototherapy, led to significant improvements in skin clearance for patients with moderate to severe psoriasis. This suggests that meditation may play a role in managing psoriasis alongside conventional therapies.

Heartfulness meditation, a specific form of meditation practice, focusses on cultivating inner peace and emotional regulation through a simple technique.[8] Preliminary evidence suggests that heartfulness meditation can reduce stress and improve sleep quality in the general population.[9] However, there is a paucity of well-designed studies investigating the effectiveness of heartfulness meditation in managing psoriasis, particularly when used as an adjunct therapy with standard treatments like methotrexate.

This study aims to address this gap in knowledge by evaluating the efficacy of heartfulness meditation alongside methotrexate compared to standard methotrexate treatment alone in patients with moderate to severe psoriasis. The primary objective was to evaluate the effectiveness of heartfulness meditation as an adjunct to methotrexate in achieving a 75% reduction in Psoriasis Area and Severity Index (PASI) scores (PASI 75) at 4 months. Secondary objectives included assessing changes in body surface area (BSA) involved in psoriasis, Dermatology Life Quality Index (DLQI), Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI), and biomarkers (serum cortisol and IL-6 levels).

Materials and Methods

Study design

This single-centre, open-label, parallel-group randomised controlled trial (RCT) evaluated the efficacy of heartfulness meditation as an adjunct therapy for moderate to severe psoriasis alongside standard methotrexate treatment. The study adhered to the CONSORT guidelines.[10]

Ethical approval

Ethical clearance was obtained from the Institute Ethics Committee (Human Studies) of AIIMS, Mangalagiri, Andhra Pradesh (Approval number: AIIMS/MG/IEC/2022-23/203). The trial was registered in the Clinical Trials Registry of India (CTRI) (Registration number: CTRI/2022/12/047862). The study commenced on 9 December 2022 and concluded on 20 November 2023, allowing adequate time for participant enrollment and follow-up.

Participants

Eligible patients attending the dermatology OPD at AIIMS, Mangalagiri, Andhra Pradesh were screened from 9 December 2022 to 20 November 2023. Participants were provided with detailed study information and assessed for eligibility. Adults aged 18–60 years with moderate to severe psoriasis (BSA >10% or PASI >10, DLQI >10) confirmed by a dermatologist were included. Exclusion criteria were pregnancy, lactation, pre-existing psychiatric or serious medical conditions, recent disease onset, and regular yoga or meditation practice within the past 3 months. Written informed consent was obtained from all participants.

Study flow is given in Figure 1.

Figure 1.

The study flow/work flow

Sample size

Based on literature suggesting a 40% PASI 75 achievement with methotrexate,[11] the study aimed for an 85% PASI 75 achievement in the intervention group. Using nMaster 2.0 with 80% power and 5% significance, a sample size of 22 per group was calculated, increased to 25 per group (total n = 50) to account for a 10% attrition rate.

Randomisation

Block randomisation with concealed allocation (a block size of 8) was used to assign participants equally (1:1 ratio) to either the intervention or control group. An independent researcher prepared the random sequence in sealed envelopes.

Blinding

Complete blinding was not possible due to the nature of the intervention. However, outcome assessors, blinded to group allocation, collected and interpreted clinical data (BSA, PASI, DLQI, PSQI) and blood test results at baseline and follow-up visits to minimise bias.

Baseline assessment

Following enrollment, all participants underwent a comprehensive baseline assessment to capture the following:

• Sociodemographic data (age, gender)

• Medical history

• Disease characteristics (BSA, PASI, DLQI) assessed by a trained dermatologist using standardised protocols.

• Perceived stress levels using a validated tool, the PSS

• Sleep quality using the PSQI

• Blood sample collection for baseline assessment of serum cortisol and IL-6 levels, analysed by a qualified laboratory technician following established protocols.

Intervention

Group 1: Heartfulness Meditation + Standard Methotrexate Treatment: Participants in this group received the standard dose of methotrexate (7.5 mg/week to 25 mg/week) as determined by the treating dermatologist, along with the heartfulness meditation intervention for 8 weeks. Practice follow-up sheets were used to track participants’ daily home practice and attendance at the weekly group sessions. Only participants with a minimum of 80% attendance in both home practice and group sessions were considered for data analysis. This ensured adherence to the intervention protocol and allowed for evaluation of the impact of the meditation practice on the intended outcomes. Participants were encouraged to contact the co-investigator (phone number provided) if they had any questions or required clarification regarding the practice.

Group 2: Standard Methotrexate Treatment: Participants in Group 2 received the standard dose of methotrexate (7.5 mg/week to 25 mg/week) as determined by the treating dermatologist. They did not receive the heartfulness meditation intervention.

Follow-up Assessments: Clinical assessments were conducted at baseline and at follow-up visits at 1, 2, 3, and 4 months after baseline. These assessments included:

• Disease severity scores: BSA, PASI, and DLQI, assessed by the same trained dermatologist who conducted the baseline assessment to ensure consistency.

• Sleep quality using the PSQI.

• Blood sample collection for assessment of serum cortisol and IL-6 levels at baseline and at the end of the 4-month follow-up period. Blood samples were collected and analysed by a qualified laboratory technician following established protocols to minimise variability.

Statistical analysis

Data entry was done using MS Excel, and statistical analysis was done using IBM SPSS statistics version 22. Both descriptive and analytical statistics were used to analyse the data. Baseline characteristics of the patients with psoriasis were presented by descriptive statistics. Categorical data such as gender and clinical factors were described using percentages. The normally distributed data was described by mean ± standard deviation. Paired t-test was be used to assess the changes from baseline to 4 months in the continuous variable within each intervention group for parametric and non-parametric data, respectively. Time to occurrence of PASI 75 between groups was estimated by using Chi-square test. 95% confidence interval was calculated and reported for the outcome measures, and statistical analysis was carried out at 5% level of significance and P < 0.05 was considered as statistically significant. Data analysis as per intention to treat analysis was done.

Results

Table 1 presents the demographic characteristics of the participants enrolled in the study. The mean age of the study population was 42.72 years, with a standard deviation of 10.66 years, ranging from 19 to 60 years, and a median age of 41 years. The male-to-female ratio was approximately 2.125:1, indicating a higher proportion of male participants. Nine out of 50 participants were smokers, and ten out of 50 reported alcohol consumption. Additionally, a family history of psoriasis was present in three out of 50 patients. Moreover, chronic conditions such as diabetes, hypertension, and hypothyroidism were reported in nine, five, and two out of 50 patients, respectively.

Table 1.

Sociodemographic details (n=50)

Variable	Number	Percentage
Gender
• Male	34	68.0
• Female	16	32.0
Smoker	9	18.0
Alcohol	10	20.0
Family H/o Psoriasis	03	06.0
Chronic Disease
• Diabetes Mellitus	09	18.0
• Hypertension	05	10.0
• Hypothyroidism	02	04.0
Body Mass Index
• Normal	10	20.0
• Overweight/Obese	40	80.0
Occupation
• Driver	05	10.0
• Housewife	12	24.0
• Student	03	06.0
• Farmer	05	10.0
• Teacher	03	06.0
• Shopkeeper	05	10.0
• Executive Officer	01	02.0
• Advocate	01	02.0
• Supervisor	01	02.0
• Hotel Worker	02	04.0
• Loco pilot	01	02.0
• Businessman	02	04.0
• Police	02	04.0
• Construction worker	01	02.0
• Civil Engineer	01	02.0
• Real Estate	01	02.0
• Carpenter	01	02.0
• Telecom	01	02.0
• Assistant Manager	01	02.0
• Mechanic	01	02.0
	01	02.0

Table 2 investigates the impact of heartfulness meditation on achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI 75). The intervention group, receiving meditation alongside methotrexate, demonstrated a higher percentage of patients achieving PASI 75 (61.1%) compared to the control group, which received methotrexate alone (52.38%). However, the Chi-square test showed no statistically significant difference between the groups (P value = 0.548), suggesting that heartfulness meditation may not significantly enhance the achievement of PASI 75 compared to standard treatment alone.

Table 2.

Comparison of PASI 75 between control and interventional groups

Variable	Intervention Group n (%)	Control Group n (%)	P
PASI 75 Attained	11 (61.1)	11 (52.38)	0.548
PASI 75 Not Attained	07 (38.9)	10 (47.61)
Total	18	21

Comparison was done using Chi-Square test; PASI

Table 3 evaluates the effects of heartfulness meditation on various outcomes, including BSA scores, DLQI scores, PSS scores, and PSQI scores. Both the control and intervention groups demonstrated significant reductions in BSA scores post-intervention, indicating an improvement in psoriasis severity. Additionally, significant decreases in DLQI, PSS, and PSQI scores were observed in both groups, reflecting improvements in quality of life, perceived stress levels, and sleep quality, respectively. While the intervention group showed greater reductions in these scores compared to the control group based on effect size, the differences were not statistically significant. Cohen’s d analysis revealed effect sizes of approximately 0.96 for BSA scores, 0.75 for DLQI scores, 0.88 for PSS scores, and 0.23 for PSQI scores within the control group and approximately 1.57 for BSA scores, 1.18 for DLQI scores, 1.21 for PSS scores, and 0.55 for PSQI scores within the intervention group.

Table 3.

Pre post comparison and comparison between control and interventional groups

Variable	Control group (n=21)		Intervention group (n=18)		Comparison between groups P
	Mean	SD	Mean	SD
BSA Baseline	23.66	19.09	32.88	20.90	0.692
BSA Follow up	7.95	12.04	7.22	7.36	0.045
Pre post comparison within group	<0.001		<0.001
DLQI Baseline	4.00	4.19	6.18	4.85	0.527
DLQI Follow up	1.20	1.58	1.35	2.06	0.256
Pre post comparison within group	<0.001		<0.001
PSS Baseline	9.70	4.19	10.88	6.07	0.115
PSS Follow up	6.40	3.86	5.53	3.28	0.502
Pre post comparison within group	<0.001		<0.001
PSQI Baseline	3.15	4.31	3.24	3.73	0.552
PSQI Follow up	2.15	3.62	1.53	2.27	0.057
Pre post comparison within group	<0.001		<0.027

BSA – body surface area; DLQI – Dermatology Life Quality Index; PSS – Perceived stress scale; PSQI – Pittsburgh sleep quality index; Within group comparison was done using paired Student’s ‘t’ test. Between group comparison was done using unpaired Student’s ‘t’ test

Table 4 examines the alterations in cortisol and IL-6 levels following the intervention. Both the control and intervention groups experienced significant changes in cortisol and IL-6 levels post-intervention. While the intervention group exhibited larger effect sizes for the decrease in cortisol and IL-6 levels compared to the control group. Cohen’s d analysis revealed effect sizes of approximately 0.45 for cortisol levels and 0.21 for IL-6 levels within the control group and approximately 0.88 for cortisol levels and 0.49 for IL-6 levels within the intervention group.

Table 4.

Pre post comparison and comparison of biomarkers between control and intervention groups

Variable	Control group (n=20)		Intervention group (n=17)		Comparison between groups P
	Mean	SD	Mean	SD
Cortisol Baseline	268.51	172.0	280.84	137.08	0.364
Cortisol Follow up	332.29	138.25	372.79	139.86	0.951
Pre post comparison within group	<0.001		<0.001
IL – 6 Baseline	7.98	4.77	7.95	3.62	0.270
IL – 6 Follow up	6.99	2.17	6.18	2.05	0.901
Pre post comparison within group	<0.001		<0.001

*Statistically significant

Discussion

Psoriasis, a chronic inflammatory skin disorder,[12] poses substantial challenges to patients due to its physical discomfort, aesthetic concerns, and impact on mental well-being.[13,14] While conventional treatments like methotrexate have shown efficacy in managing psoriasis symptoms, the quest for adjunctive therapies to improve outcomes and quality of life continues. The present study investigates the potential of heartfulness meditation as a supplementary approach to conventional treatment for psoriasis patients.

The demographic profile of the participants underscores the typical characteristics observed in psoriasis cohorts, such as a male predominance and the presence of comorbidities like smoking, alcoholism, and chronic diseases including diabetes and hypertension. Understanding these demographics provides valuable context for interpreting study outcomes within the broader population of psoriasis patients.

A major finding in our study is that after 4 weeks of meditation, we observed a significant decrease in the inflammatory marker IL-6 in the meditation group, along with a reduction in PASI scores. This finding aligns with previous research, such as Fordham et al.’s[15] study on Mindfulness-Based Cognitive Therapy (MBCT), which also reported reduced PASI scores in patients with moderate-to-severe plaque psoriasis. This suggests that heartfulness meditation might be a valuable tool for reducing the extent of psoriatic lesions.

One possible explanation lies in the stress-modulating effects of meditation.[16] Psoriasis is known to be exacerbated by stress,[3] and previous studies, including a heartfulness intervention in post-COVID patients, have documented reduced inflammatory parameters following 4 weeks of meditation practice.[17] In our study, we observed a dampening of the inflammatory response, as evidenced by decreased IL-6 levels among psoriasis patients following meditation. This effect could be attributed to the sense of calmness and emotional regulation induced by heartfulness meditation, which helps reduce the inflammatory process associated with the disease.

Interestingly, despite the reduction in inflammation, we observed an increase in cortisol levels in both the control and experimental groups following the intervention. Cortisol has a complex and varied relationship with inflammation, serving as both a regulator of stress[18] and a potent anti-inflammatory agent.[19] While cortisol is typically expected to decrease as stress is reduced, its levels can remain elevated or even increase under certain conditions, reflecting the dynamic nature of the body’s stress response. This seemingly paradoxical finding can be explained by several factors.

Firstly, meditation likely improved the sensitivity of glucocorticoid receptors,[20] allowing cortisol to more effectively reduce inflammation even at elevated levels. Additionally, the sustained high cortisol may represent an adaptive phase, where the body is recalibrating its stress response mechanisms as it transitions to a lower-stress state.[21] During this period, the body might still require higher cortisol production to manage baseline physiological demands or lingering inflammation until a new balance is achieved. Over time, with continued practice, cortisol levels might gradually decrease as the body fully adapts to the reduced stress environment.

In terms of clinical metrics, while meditation contributed to a reduction in BSA scores, indicative of improved psoriasis severity, the attainment of PASI 75—a widely recognised indicator of treatment success—showed no significant difference between the intervention and control groups. This discrepancy suggests that while meditation may ameliorate psoriasis symptoms, it may not necessarily achieve the stringent clinical benchmarks set by conventional treatments alone.

Beyond clinical metrics, the study explores various psychosocial and physiological parameters affected by psoriasis and potentially modulated by meditation. We observed a trend towards reduced stress levels and improved sleep quality among the meditation group, as evidenced by the PSS assessment and sleep quality measures. Significant findings might have emerged if the meditation intervention had been administered for a longer duration. A significant improvement in sleep quality among participants in the psoriasis meditation group was also observed, which could explain the decreased IL-6 levels following meditation intervention.

Quality of life is affected in psoriasis patients due to the subjective nature of psoriasis, with its impact on appearance and social interaction. Both groups showed a significant improvement in quality of life, with a trend benefiting the meditation group as observed by improved DLQI scores. This aligns with the established benefits of meditation for enhancing quality of life, well-being, and managing chronic health conditions.[22,23,24] Our study emphasises that heartfulness meditation can empower patients by fostering self-compassion, acceptance, and a better ability to cope with the challenges of the disease.

Limitations and future directions

This study suggests potential benefits of heartfulness meditation for psoriasis management but has limitations. The relatively modest sample size—designed to detect large effects based on preliminary meditation research—may have limited power to confirm the observed modest effect sizes (e.g., 61.1% vs 52.38% PASI 75). While this precludes definitive efficacy conclusions, the consistent trends across clinical (BSA, PASI), psychological (PSS), and biomarker (IL-6) outcomes provide a compelling rationale for future trials. Additional constraints include the short follow-up period and exclusive focus on heartfulness meditation, which may affect generalisability and durability assessments. Future research should investigate long-term outcomes (e.g., recurrence rates, sustained improvements) and potential synergies with other non-pharmacological interventions (e.g., dietary modifications, stress management) to advance multimodal psoriasis care.

Conclusion

This study provides preliminary evidence suggesting that heartfulness meditation might be a beneficial adjunct therapy for psoriasis, particularly for reducing disease severity and improving quality of life. The trends towards reduced stress, improved sleep, and lower inflammatory markers warrant further investigation. Future research with robust designs and larger samples is needed to definitively establish the role of heartfulness meditation in psoriasis management. If future studies confirm these findings, incorporating meditation into a holistic treatment plan for psoriasis could empower patients to manage their condition more effectively and improve their overall well-being.

Trial registration

CTRI/2022/12/047862.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

The project is funded by institute intramural fund ([IMF 2022-3, Institute intramural funding).