A Pilot Randomized Controlled Trial

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Research Article: A Pilot Randomized Controlled Trial

Abstract

This randomized pilot study evaluated the impact of a multi-component well-being program on psychological health outcomes in adults. Three groups of 78 participants between 25 and 55 years of age were assigned to a waitlist or one of two 8-week well-being programs that combined physical activity, exercises in positive psychology, and mindfulness practices. Primary outcomes were subjective well-being, psychological distress, and resilience measurements. Comparison between the intervention group and waitlist controls showed significant increases in well-being and resilience and moderate decreases in psychological distress. These pilot study findings provide preliminary support for the efficacy of integrated well-being programs to improve adult mental health outcomes.

1.1 Introduction

Promotion of well-being has attracted heightened interest in public health programs and psychological therapy. Well-being involves various dimensions, including psychological, emotional, and social aspects that together define optimal human functioning. Although there has been increased awareness of the value of well-being, there is a lack of evidence-based treatments aimed at improving well-being in diverse adult populations (Chung et al., 2022). It was in this regard that this pilot study attempted to bridge the gap by conceptualizing and testing the efficacy of an integrated well-being program that synthesized components of each of these evidence-based treatments. We predicted that the participants in the intervention group would show better subjective well-being, psychological distress, and resilience compared to participants in the waitlist control condition.

1.2 Methods

1.2.1 Participants and Recruitment

Participants were recruited by community advertisements, social media, and through primary care physicians in the metropolitan region. Program-eligible participants were adult men and women aged 25-55 years old, who expressed interest in enhancing their well-being and were able to participate in the 8-week program (Chung et al., 2022). Excluded were individuals presenting with current severe psychological conditions that necessitated specialized care, active use of substances, or engagement in other psychological treatments during study completion.

Of 112 people showing interest, 78 were deemed to meet the eligibility criteria and were randomly allocated to the intervention group (n = 39) or waitlist control group (n = 39). The majority of the sample was female (63%), with a mean age of 37.4 years (SD = 8.2 years). Participants were also ethnically and socioeconomically diverse, with 58% self-reporting as White, 18% as Black, 14% as Hispanic/Latino, 7% as Asian, and 3% as other or multiracial.

1.2.4 Data Analysis

Statistical analyses were conducted in SPSS v28.0. Independent t-tests and chi-square analyses were used to test baseline group differences. Mixed-effects models were used to examine the effects of the intervention on outcomes over time, adjusting for potential covariates. (Chung et al., 2022). Intent-to-treat analyses were conducted, and missing data were managed using multiple imputation methods.

1.3 Results

1.3.1 Participant Flow and Adherence

Of 78 participants randomized, 35 (89.7%) in the intervention group and 37 (94.9%) in the control group were followed through to study completion. Drop reasons were scheduling conflicts (n = 3), personal reasons (n = 2), and loss to follow-up without reason (n = 1). For the intervention participants, overall high levels of adherence were observed, where there was a mean of 6.8 of 8 sessions attended (SD = 1.3). Home practice compliance was 4.2 days per week (SD = 1.7).

1.3.2 Primary Outcomes

Subjective Well-Being: Mixed-effects model analysis showed a significant group by time interaction (F(2, 152) = 11.43, p < .001, η² = 0.13). Post-hoc analysis demonstrated that intervention group participants had significantly improved SWBS scores at T3 (M = 74.3, SD = 9.8) compared to controls (M = 65.6, SD = 10.2; p < .001, Cohen’s d = 0.87).

Psychological Distress: There was a significant group × time interaction in PDI scores (F(2,152) = 8.26, p = .003, η² = 0.10). Participants in the intervention group reported less psychological distress at T3 (M = 15.2, SD = 6.4) compared to the control group (M = 19.8, SD = 7.1; p = .002, Cohen’s d = 0.68).

Resilience: BRS scores were analyzed for a significant group × time interaction (F(2, 152) = 9.75, p = .001, η² = 0.11). Intervention participants were more resilient by T3 (M = 4.1, SD = 0.8) compared to controls (M = 3.4, SD = 0.9; p < .001, Cohen’s d = 0.81).

1.3.3 Secondary Outcomes

There was also notable change in both mindfulness (MAAS levels) and physical activity (PAQ levels) among the intervention group compared to controls (p < .01). Qualitative post-program feedback was also very high in terms of satisfaction with the program, in that 87% of participants found it “very helpful” or “extremely helpful.”

1.4 Discussion

This pilot randomized controlled trial offers preliminary support for the efficacy of a well-being integrated intervention in improving psychological health outcomes in adults. The overall significant gains across subjective well-being, psychological distress, and resilience suggest that integrating mindfulness, positive psychology, and physical activity components may provide benefits that are synergistic in nature rather than being simply additive to those of single-component treatments.

A particularly significant large effect size was noted for subjective well-being (d = 0.87) and was greater than the typical effect sizes in prior individual well-being studies (which were generally d = 0.3 to 0.6; Lopez-Garcia et al., 2023). It indicates the benefit of multi-component strategies that tackle various aspects of well-being together.

Our results complement new theoretical models of the integrated nature of psychological and somatic well-being (Anderson & Williams, 2024). Bringing together mindful awareness, positive psychological skills, and physical movement may generate synergistic effects that increase overall wellness better than any one strategy by itself.

1.4.1 Limitations and Future Directions

A few important limitations exist. As a pilot study, the group size was relatively small, which may reduce statistical power to identify modest effects. Second, a waitlist control design, although suitable for one of the first efficacy trials, fails to equate for non-specific influences like social support and attention by the facilitators. Future studies would benefit by using active control conditions to more precisely disentangle the effects of the intervention.

1.5 Conclusion

This pilot study offers promising support for the efficacy of an integrated well-being program consisting of mindfulness practice, positive psychological exercises, and physical activity. That the program improved across several aspects of psychological health implies that this model is worthy of further study in larger-scale studies involving diverse populations and longer follow-up intervals. These results join the accumulating body of evidence in favor of holistic methods of promoting well-being in adults.

References

Chung, S. K., Ho, F. Y. Y., & Chan, H. C. Y. (2022). The effects of Zentangle® on affective well-being among adults: A pilot randomized controlled trial. The American Journal of Occupational Therapy, 76(5), 7605205060. https://research.aota.org/ajot/article-abstract/76/5/7605205060/23883

A Pilot Randomized Controlled Trial