Effect of an online mindfulness program on stress in Indian adults during COVID-19 pandemic: A randomized controlled preliminary study.

Background: The Indian population is suffering from a high prevalence of mental stress and the situation has been worsened by the COVID-19 pandemic. Mindfulness, which can also be conducted online, has been used as a stress-relieving therapy in the Western world. There is not much experience with mindfulness in the Indian population. The COVID-19 pandemic demands the development of alternative therapies which can reach out to the masses at a minimal cost, avoiding direct personal contact. The researchers wanted to explore the potential of mindfulness as a stress-relieving therapy. Aim: To note any improvement in perceived stress of the participants compared to the controls.
Methods: Ninety apparently healthy adults were randomized into group M (all of whom participated in an online mindfulness program) and group C (all of whom attended placebo sessions), with 45 participants each. Final sample size was n = 42 (group M) and n = 38 (group C). The perceived stress was measured using the perceived stress scale before and after the program. Qualitative data was collected in the form of written responses to the question "Which aspect of mindfulness meditation appealed to you the most for stress relief?" and some themes were formed.
Results: There was a significant decrease in perceived stress scale scores on completion of the program in group M. "Positive mental state" and "non-judgmental" were the most prominent emergent themes suggested by the participants, as per the qualitative data analysis.
Conclusion: This preliminary study sees potential in an online mindfulness program as an alternative stress-relieving therapy. Further research is suggested to substantiate the results and optimize the implementation. Copyright:

INTRODUCTION

Mental disorders are the main cause of non-fatal disease load in India, and they negatively affect a large proportion of the Indian population.[1] The outbreak of the COVID-19 pandemic has increased anxiety, depression and stress and has caused serious damage to mental health.[2] A recent study on the Indian population during the COVID-19 pandemic reported a prevalence of moderate level of stress in 74.1% of its participants.[3] The pandemic has created an utmost need for perceived mental health care services in India.[4] Important considerations during the pandemic are minimizing direct face-to-face interactions, availability at community level and easy accessibility.[5] As in-person hospital-based services are limited or delayed, additional online services can be of definite advantage.[6] Online group therapies provide additional advantages, can be attended by a large number of people at a time, reach out to remote areas, delivered at a minimal cost, and accessed from the convenience of one’s home. This can be helpful for a populous country like India. Alternate stress relief therapies can never be a replacement for standard established psychological and psychiatric therapies. But they can be a valuable addition to total mental health management for the varied and heterogeneous Indian population.

Mindfulness was initially developed by Kabat-Zinn as an outpatient mindfulness-based stress reduction (MBSR) program.[7] It was found to be useful to decrease stress levels in an apparently healthy population.[8] Mindfulness has gained popularity in the Western world and MBSR programs have been modified into more convenient forms called mindfulness-based interventions (MBI). One important aspect of these interventions are they can also be delivered online. A meta-analysis infers that online interventions also have the potential to reduce stress.[9] But mindfulness has been rarely used for stress relief in the apparently healthy Indian population, which was evident from a paucity of research studies in the Indian context. We have not come across any study which has used online mindfulness as a stress-relieving therapy in this population. We searched for alternative therapies in the form of online mindfulness and see its effect on perceived stress scores (PSS)[10] in the apparently healthy Indian adults during the COVID-19 pandemic.

The primary aim of the study was to observe any improvement in perceived stress scores of the participants compared to the controls. We formulated a hypothesis that the participants by attending this program would report a decrease in the PSS at the end of the program. Additionally, qualitative data was collected in form of written responses to the question “Which aspect of mindfulness meditation appealed to you the most for stress-relief?” and emergent themes were formed to help in future studies. This study is the first attempt to see the effect of online mindfulness intervention on perceived stress in Indian adults.

METHODS

The study aimed to note any decrease in PSS in apparently healthy Indian adults participating in an online mindfulness program during the COVID-19 pandemic. The study was conducted by a medical institution in collaboration with a mindfulness center, based in West Bengal, India. Institutional ethical approval was obtained and informed consent was taken from all participants.

Sample size calculation

We calculated our sample size from the previous studies[11] to detect a minimum expected difference of means (m1−m2) of 3.13 at least with a standard deviation (SD) of 4.6 with a power of >80% and Type I Error (alpha) of <5% using Welch’s t test to compare the difference of means between two groups with unequal variances. The calculated sample size came out as 76, with a minimum of 38 individuals in each group.

Recruitment

Advertisements were given on social media, and all adults interested in joining an online mindfulness program in May–November 2020 were informed about the study. Out of 107 willing candidates, 90 participants were screened by the researchers. The participants were residents of Kolkata, India. Initial screening was based on responses to an email questionnaire consisting of inclusion and exclusion criteria. To involve only apparently healthy adults, a self-declaration stating that they were not suffering from any psychiatric illnesses was taken from the candidates during initial screening. Selected participants were randomized into online mindfulness (group M) and control (group C) groups containing 45 candidates each. The randomization was done manually using a random number table of Fisher and Yates. The 45 candidates of group M participated actively in the online mindfulness program while the 45 candidates in group C attended similar placebo sessions during the study period. The placebo sessions included online discussion on stress relief with the same instructor of similar duration, excluding the concept and exercises of mindfulness. Placebo sessions covered advice on simple stress relief measures like regular physical exercise, dietary modifications, listening to music and relaxation exercises to combat stress. Candidates of group C were later offered to join the online mindfulness program after the study period, which is beyond the scope of the present discussion. Three candidates in group M and seven candidates in group C did not complete the study. Final sample size was (n = 42) for group M and (n = 38) for group C [see Figure 1].

Figure 1

Recruitment of study subjects

Inclusion criteria

The following were the inclusion criteria: (1) age between 18 and 65 years; (2) have access to electronic device; (3) no major physical illness (4) no psychiatric illness (as per self-declaration of participants in initial screening); (5) not undergoing psychiatric treatment and no plans of any psychological therapy during the study period; (6) no significant drug history; (7) level of education higher than higher secondary standard; (8) ability to spend 20 minutes daily on formal practices throughout the course; (9) have to be a resident of India.

Exclusion criteria

The following were the exclusion criteria: (1) presently suffering from active coronavirus infection or suffered from a coronavirus infection in the recent past; (2) previous experience of mindfulness meditation.

Intervention

The online mindfulness program had five sessions and was compiled from the elements of eight-week original MBSR program. The online program was inspired by the NHS-approved website-based program (http://www.bemindfulonline.com), modified for the Indian population. The program consisted of an introductory session and four main sessions, one session each week. The total duration of the program was five weeks. The sessions were conducted live through an application that could be downloaded on a smartphone, tablet or computer, or any electronic device. The introductory session was of half-an-hour duration where the whole program was explained to the participants. The main sessions were approximately two hours in duration. Any participant missing any of the sessions was removed from the study. The mindfulness instructor was trained via the original MBSR program, NHS-approved digital mindfulness course and other accredited courses, and had experience of teaching mindfulness for more than two years. During the live sessions, formal meditation skills (sitting meditation, three minutes breathing space), informal meditation skills (incorporation of mindfulness in daily activities) and mindfulness concepts (positive mental state, acceptance, non-judgmental, self-compassion, gratitude) were discussed. Participants were instructed to do a daily formal practice of meditation for 20 mins and daily informal practice of approximately 30 mins. The daily duration of practice time was fixed, as one of the previous studies found a small association between the extent of formal practice and positive outcomes.[12] The daily practice of formal, informal and mindfulness activities was self-reported by participants and monitored through a social media application. The doubts of the participants were clarified by interacting with the instructor through this application. There was no face-to-face interaction of the participants with the mindfulness instructor. The control group participants attended similar online placebo sessions on stress relief conducted by the same instructor of similar duration. They daily practiced the physical exercises and relaxation exercises in a similar schedule. Any participant experiencing any discomfort or adverse effect during the program was asked to report to the instructor via the application.

Assessment

The demographic data was noted for both group M and C before the program. The PSS was self-reported by the participants of both groups before the start and at the end of the program. We chose a 10-item PSS to measure stress in our study population. The PSS is scored on a five-point scale. High scores on the PSS correlates with increased levels of stress. This scale is known to have good reliability, validity, and sensitivity to change.[13] On the completion of the program, qualitative data was collected from the candidates of group M (n = 42). Group M participants mailed their written responses to the question “Which aspect of mindfulness meditation appealed to you the most for stress-relief?” Five emergent themes included in the program were given as choices to the above question: positive mental state, acceptance, non-judgmental, self-compassion, and gratitude. The participants sent the appropriate responses through mail. The concept behind the collection of this qualitative data was to expand our understanding of mindfulness meditation and stress relief in this particular study population. The researchers felt that the themes emphasized by the participants can give directions to future research. The overall experience of the participants with the program was noted as a subjective measure. This will serve as an indirect measure of acceptability of the online mindfulness program in the study population.

Statistical analysis

Data of stress levels measured by PSS scoring was treated as continuous. Normality was confirmed via Kolmogorov–Smirnov test (skewness = 0.402 (potentially symmetric)). The analysis of continuous data was performed using Welch’s t test because of change in sample variance due to change in sample size from 45 participants in each group pre-session to 42 in Group M and 38 in Group C post session. P < 0.05 was considered statistically significant. The results were further followed up with ES (Cohen’s d) and reliability measured by the reliable change index (RCI). Baseline characteristics (age, sex) were tested using Welch’s t test and Chi-test respectively. Mixed model analysis of variance (ANOVA) with replication was used to compare the groups. The statistical software used was Statistical Package for the Social Sciences (SPSS) for Windows 7® version 18.0.0 (Chicago, IL 60606-6412) and GraphPad Prism® InStat version 18.0.1© 2018 (GraphPad Software Inc. CA 92037-3219) and Microsoft® Office Excel 2010 (Washington: Microsoft). Charts were compiled by Excel and an online chart drawing tool at https://www.meta-chart.com/.

RESULTS

A total of 90 individuals screened for the study were randomized into two groups of 45 each, of which three participants in Group M and seven in Group C dropped out of the study. So, 80 participants (42 in Group M and 38 in Group C) were able to complete all of the sessions and were thus included in post-session data analysis [Figure 1].

Quantitative data analysis

The age and sex distribution (baseline characteristics) between Group M and C were similar. Welch’s t test (due to unequal variances) showed no significant difference in mean age and sex distribution between groups M and C (P = 0.8760 and P = 0.8139, respectively) [Table 1].

Table 1

Age, Sex distribution and PSS scores

Pre-Session
	Group M (n=45)	Group C (n=45)	Group M vs C	Result
Age (years)	42.73 (10.44)	42.38 (10.78)	Welch’s t-test	t(87)=0.1565
Mean (SD)				P=0.8760
Sex	Male=13 (28.89)	Male=12 (26.67)	χ2 test	χ2=0.0554
Number (%)	Female=32 (71.11)	Female=33 (73.33)		P=0.8139
PSS Scores	22.71 (5.01)	23.51 (4.64)	Welch’s t test	t(87)=0.7859
Mean (SD)				P=0.4341
		Post Session
	Group M (n=42)	Group C (n=38)
PSS Scores	15.73 (4.62)	23.06 (5.02)	Welch’s t test	t(75)=6.7726
Mean (SD)				P<0.0001

Age and sex distribution of participants along with pre-session and post-session PSS scores including chi-values and t-values and significance between group M and group C. Initially, 45 participants were enrolled, three persons in group M and seven persons in group C dropped out of the study. M = Mindfulness group, C = Control group, SD = Standard deviation, n = number of participants in that particular group

The PSS scores of groups M and C were grouped into pre-session and post-session in mean (SD) format. The mean PSS scores of groups M and C showed no significant difference by Welch’s t test of pre-session values (P = 0.4341). Mean (SD) PSS scores post-session in Group M [15.73 (4.62)] decreased significantly compared to group C [23.06 (5.02)] with P < 0.0001 by Welch’s t test [Table 1] with 95% CI = −9.4860 to −5.1740. This change showed a large effect size (Cohen’s d = 1.523) and was statistically a reliable change (RCI = 5.73). The above variations in mean (SD) PSS scores are depicted visually via a box plot diagram [Figure 2]. PSS change from Pre–Post was further evaluated by a mixed model ANOVA with replication where Pooled 2 Pre-session groups (Group G and Group M) were compared first with Post-session of group M which revealed that the variance of post-session differed from pre-session variances with F (1,129) = 13.9859; P = 0.0002. The Pre-session Groups compared with Post-session of Group C did not reveal any significant change with F (1,125) = 1.8336; P = 0.4467. Thus, a significant change was observed in post-session group M by mixed model ANOVA with replication.

Figure 2

Representation of mean PSS scores pre and post session of group M and group C

Qualitative data analysis

Emergent themes from post-session questionnaires were #1PositiveMentalState, #2Acceptance, #3NonJudgmental, #4SelfCompassion, and #5Gratitude with frequency of participant response as 40, 22, 34, 15 and 24 respectively. Arranging the data in ascending order and calculating cumulative frequencies (cf) we get #4SelfCompassion (f = 15, cf = 15), #2Acceptance (f = 22, cf = 37), #5Gratitude (f = 24, cf = 61), #3NonJudgmental (f = 34, cf = 95), #1PositiveMentalState (f = 40, cf = 135).

As can be seen from the histogram, the 50th percentile (67.5) falls on #3NonJudgemental theme, the 75th percentile (101.25) falls on #1PositiveMentalState, while #2Acceptance and #5Gratitude falls between 25th percentile (33.75) and 50th percentile. So priority of emergent themes are as follows. “No full stop after Emergent”.

Themes are as follows: #1 > #3 > #2 = #5 > #4. Positive mental state appears to be the most prominent theme followed by Non-judgmental, as depicted visually in cumulative frequency histogram [Figure 3].

Figure 3

Qualitative data analysis

The subjective experience of the group M participants indirectly suggested the well acceptability of the online mindfulness program in the study population.

No discomfort or adverse effects were reported by the subjects during the study period.

DISCUSSION

The results of this study support the hypothesis that the participants attending the online mindfulness program report a decrease in the PSS scores at the end of the program. The mean PSS scores post session in group M decreased significantly compared to control group C with P < 0.0001. The results are consistent with previous studies conducted in other parts of the world. A randomized waitlisted control trial with 118 adults found a significant decrease in PSS with the application of online mindfulness in a non-clinical sample population.[14] In our study, the participants chose “positive mental state” and “non-judgmental” as the most prominent themes for stress relief. One previous study also suggested that “non-judgmental” was responsible for stress reduction.[13] Future studies will be able to throw more light on each specific attribute playing a significant role in a mindfulness program.

The increasing stress in the Indian population was a matter of concern even before the COVID-19 pandemic started.[1] The pandemic worsened the situation; a study estimated the prevalence of moderately-to-extremely, severely depressed, and anxious and depressed to be 25.1%, 28% and 11%, respectively, during the pandemic.[15] An online survey from India suggested the need for mental health services to reach out to everyone in society to address this major problem.[3] A review commented that an extensive effort from the entire health care system will be required to handle the crisis. It also suggested the need to develop mental health interventions that are time-limited and culturally sensitive.[16] The development of online materials for mental health education during the pandemic was greatly encouraged.[17] Internet and smartphone application–based interventions were suggested to address the problem.[1] The present crisis prompted researchers to think of an alternative intervention which can be delivered online through applications using electronic devices. Mindfulness came up as a feasible additional tool that may be helpful in the extensive mental health needs of the country, but its experience in culturally different Indian population was limited.

The original MBSR program started in Western countries, had eight 2.5-hour weekly sessions, one 7-hour period of silence, and home practice of 45 minutes daily.[18] Some systemic reviews infer MBSR as a promising therapy for stress management[19] and improvement in psychological functioning.[20] With time, MBSR was modified to more convenient MBIs which were found to be equally effective in reducing anxiety and depression.[21] One of the fascinating aspects of MBIs was that it could also be conducted through an online platform and could be provided at a lesser cost.[22] Meta-analysis on online MBIs suggested that they may act as a better alternative in the busy, hard-to-reach and digitally-accessible populations.[23] The duration of MBIs usually ranges from eight weeks to as short as two weeks.[24] In contrast to the original eight-week MBSR, we chose a shorter version of online MBI of five weeks because of limited experience of mindfulness in the Indian population and anticipated difficulty in keeping participants engaged for such a long time. Some components of MBSR (e.g., seven-hour period of silence) were dropped due to lack of feasibility and appropriateness in our context.

The researchers have not come across any study on online mindfulness in the Indian population. After an extensive search, a few studies with in-person, face-to-face mindfulness in the different study populations were found. Mindfulness was used in rural Indian women to cope with perinatal grief.[25] In a study of 74 Indian pregnant women, it was found that mindfulness could significantly decrease perceived stress.[26] Another study on patients with coronary heart diseases found that MBSR decreased perceived stress scores in this group of patients.[27] In our study, in addition to the decrease in PSS, the subjective experience of the participants suggest there was no difficulty in understanding the concepts of mindfulness, sessions conducted via the use of electronic media were well accepted, and they found this learning helpful. No adverse effect was reported by any participant during the program. This is consistent with the previous findings that engagement in MBSR is not predictive of increased rates of harm relative to no treatment.[28]

In the COVID-19 pandemic scenario, avoiding exposure, social distancing and home isolation are important considerations. The online mode of this intervention has several advantages in the present background. Avoiding direct personal contact, reaching out to remote places, accessibility by frail and physically disabled persons, availability to a larger population, and delivery at a minimal cost are some of them. But alternate therapies like mindfulness are never meant to replace standard therapies, rather act as additional tools. This study was not meant to establish the superiority of mindfulness over standard therapies and comparison was beyond the scope. Our study is a preliminary one and has its shortcomings. We studied only one quantitative variable, i.e., perceived stress score. Accessibility to electronic devices is an important prerequisite to attending online programs. Maintaining the quality of mindfulness programs will also be a matter of concern during large-scale execution for the masses. It will not be perhaps appropriate to generalize the study findings to the whole population, but this study is a definite step forward toward the use of online evidence-based alternative therapy (mindfulness) in addition to standard therapies for stress relief in the Indian context. We suggest further research to substantiate the results and proper implementation.

Limitations of the study: The researchers cannot comment whether outcome measures were influenced by participants’ beliefs in the benefits of mindfulness meditation. The control group was only subjected to placebo sessions and no specific active intervention could be organized for them. The PSS scores and daily home practice were self-reported by the participants and self-reporting has its limitations. None of the other measures of stress or mindfulness could be included in this preliminary study. The participants were from Kolkata, India, so the results may not be equally applicable pan India considering the heterogeneity of the Indian population. The level of education of the participants was higher than the higher secondary standard, so the understanding of the concept of mindfulness in subjects with lower education levels needs to be further studied. A follow-up after some time interval was not feasible in this study, which restricts us from commenting on the long-term effects of this online program on stress relief.

CONCLUSION

Online mindfulness shows initial promise as an alternative therapy to deal with the increasing mental stress of the Indian population. The use of an online platform has an additional advantage in the backdrop of the COVID-19 pandemic. Further well-planned and larger studies are needed to address the limitations of this preliminary study.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.