Comparing standard and short online mindfulness therapy programs for improving well-being : the healthy mind healthy you study / Louisa Grandin Sylvia.

Format:

Book

Author/Creator:

Sylvia, Louisa Grandin, author.

Language:

English

Subjects (All):

Mindfulness-based cognitive therapy.

Well-being and quality of life.

Physical Description:

1 online resource (63 pages) : illustrations

Other Title:

Comparing standard and short online mindfulness therapy programs for improving well-being

Place of Publication:

Washington, DC : Patient-Centered Outcomes Research Institute, 2022.

Summary:

BACKGROUND: Mindfulness can improve overall well-being by training individuals to focus on the present moment without judging their thoughts. However, it is not known how much mindfulness practice and training are necessary to improve outcomes. The purpose of this study was to compare the effect of standard online mindfulness-based cognitive therapy (MBCT) with brief mindfulness training on overall well-being across 17 PCORI-funded people-powered research networks (PPRNs), online communities of stakeholders interested in a common area of research. OBJECTIVES: Our aims were as follows: (1) to determine whether standard (8-session) MBCT compared with a brief 3-session mindfulness intervention improved well-being in participants and (2) to explore whether treatment effects differed based on baseline characteristics of participants. METHODS: At baseline, participants provided consent electronically and completed questionnaires that consisted of demographic questions, medical history questions, history of psychiatric diagnoses, history of mindfulness practice, and questions relating to their role (ie, a caregiver or patient). Participants were then randomized to a standard 8-session MBCT program or a brief 3-session mindfulness intervention accessed online. Both interventions were fully automated, meaning that all training sessions and follow-up assessments were online, and participants automatically progressed through the program with no human involvement. Following the 8-week intervention stage, participants completed a 12-week follow-up period, with questionnaires every 4 weeks. The primary outcome of the study was change in well-being over the intervention period (baseline to 8 weeks) and the full study period (baseline to 20 weeks), as measured by the World Health Organization (WHO)-5 Well-being Index. Given the use of repeated measures, we conducted analyses for our primary hypothesis using general linear mixed models that account for the covariance of observations within participants (both for 8 weeks and 20 weeks). We modeled a random intercept and slope for participants and sites and fixed effects for treatment and time. The treatment by time interaction was used to assess treatment effects. RESULTS: We recruited 5029 participants; 4436 participants were randomized, of whom 2220 from the MBCT group and 2191 from the brief mindfulness group were included in outcome analyses (88% White, 80% female). Roughly 75% of participants did not complete the study, which is comparable with prior online mindfulness trials. The baseline WHO-5 mean (SD) mindfulness score was 50.3 (20.7). Average self-reported well-being in each study arm increased over the intervention period (baseline to 8 weeks) (model-based slope for the MBCT group: 0.78 [95% CI, 0.63-0.93]; brief mindfulness group: 0.76 [95% CI, 0.60-0.91]) as well as the full study period (ie, intervention plus follow-up; baseline to 20 weeks) (model-based slope for the MBCT group: 0.41 [95% CI, 0.34-0.48]; brief mindfulness group: 0.33 [95% CI, 0.26-0.40]). Change in self-reported well-being did not differ importantly between the MBCT and brief mindfulness groups during the intervention period (model-based difference in slopes: −0.02 [95% CI, −0.24 to 0.19; P = .80]) or the intervention period plus follow-up (−0.08 [95% CI, −0.18 to 0.02; P = .10]). During the intervention period, younger participants (P = .05) and participants who completed a higher percentage of intervention sessions (P = .005) experienced greater improvements in well-being across both interventions, an effect that was stronger for participants in the MBCT group. CONCLUSIONS: Standard MBCT improved well-being but, but we did not find evidence to suggest that it was superior to a brief mindfulness intervention. Younger patients and those able to complete more training sessions may improve more with standard MBCT. LIMITATIONS: This study was limited by lack of diversity in the sample (ie, the sample was largely White women) as well as a high rate of attrition, which may have been caused in part by the intervention being self-guided. Although the PPRNs were united in their interest to pursue participant-centered research, the staff at the recruiting PPRNs were nationally distributed across 17 locations. Given the demands of many of the PPRNs to support their online communities or networks as well as conduct this study, the additional administrative burdens associated with the study at times may have been too great (eg, seeking feedback from participants on study materials, editing and drafting PPRN-specific assessments and recruitment materials).

Contents:

ABSTRACT 4

BACKGROUND 6

Accessibility of Online Interventions 7

Purpose 7

PARTICIPATION OF PATIENTS AND OTHER STAKEHOLDERS 9

Figure 1 Committee Governance Structure 10

Stakeholder Input in Design Considerations 11

METHODS 12

Study Overview 12

Study Setting 12

Table 1 People-Powered Research Networks 13

Participants 14

Recruitment 14

Enrollment Procedure 14

Table 2 Study Assessments and Intervention Sessions 16

Treatment Adherence for Both Treatments 17

Interventions and Comparators 18

Table 3 Mindfulness-based Cognitive Therapy Intervention Sessions 19

Table 4 Brief Mindfulness Intervention Sessions 19

Primary Outcome, Secondary Outcomes, and Moderators 20

Study Timeline 22

Figure 2 Study Timeline 23

Data Reports 23

Analytical and Statistical Approaches 23

Changes to the Original Study Protocol 27

RESULTS 29

Overview of Participant Flow and Demographics 29

Figure 3 Enrollment Flow Diagram 30

Table 5 Demographics and Baseline Characteristics of Randomized Participantsa 32

Specific Aim 1: Differential Effects of MBCT vs Brief Mindfulness 33

Figure 4 Well-being by Week by Condition 34

Table 6 Mixed Model-based Change in Mean Outcome per Week by Treatment

Group and Period (N = 4411) 36

Table 7 Mixed Model-based Change in Mean Outcome From Baseline by

Treatment Group and Period (N = 4411) 37

Specific Aim 2: Heterogeneity of Treatment Effects 37

Table 8 Heterogeneity of Treatment Effectsa 39

Predictors of Dropout 43

Table 9 Baseline Demographics and Clinical Characteristics of Dropouts vs

Completers 44

Table 10 WHO-5 Completion by Condition 45

DISCUSSION 46

Subpopulation Considerations 48

Study Limitations 49

Future Applications and Benefits for Mindfulness Interventions 50

CONCLUSIONS 52

REFERENCES 53

ACKNOWLEDGMENTS 59

APPENDIX: SUPPLEMENTAL TABLES 60.

Notes:

Description based on publisher supplied metadata and other sources.