Determining the feasibility and acceptability of a randomized telehealth pilot study for veterans with chronic multisymptom illness

Background: The shift toward a patient-centered and whole health care model offers a promising approach for the management of symptoms among veterans with chronic multisymptom illness (CMI). A behavioral intervention aimed at reducing cognitive control dysregulation which is a component of impairments common among veterans with CMI may be helpful. Therefore, a pilot study was conducted to explore the feasibility, safety, and acceptability of a telehealth mental and physical (MAP) training intervention among veterans with CMI. Methods: Utilizing a two-arm randomized trial, participants were either randomized to 8 weeks of a directed MAP training protocol (dMAP) that received weekly guidance via text messaging or 8 weeks of self-guided MAP training (sgMAP) which did not receive guidance aside from the intervention goals. The MAP intervention was the same for both groups except for the delivery and consisted of two MAP training sessions and one telephone health coaching session per week. The primary aim of the study was to evaluate the feasibility (e.g., recruitment, retention, and adherence rates; amount of missing data), safety (e.g., adverse events), and acceptability (e.g., satisfaction) of a telehealth MAP intervention. Results: Out of 44 potentially eligible veterans, 26 were randomized to either the dMAP group (n = 13) or the sgMAP group (n = 13), resulting in a recruitment rate of 59% (26/44 patients). Two participants withdrew after randomization, resulting in 24 participants used for analyses. The retention rates at endpoint and 3-month follow-up were 79.2% (19/24; dMAP:sgMAP = 9:10) and 62.5% (15/24; dMAP:sgMAP = 7:8), respectively. Participants completed an average of 48.2% of the MAP sessions (7.7/16 sessions; dMAP:sgMAP = 7.9:7.5 sessions) and 82.8% of the health coaching sessions (6.6/8 sessions; dMAP:sgMAP = 7.2:6.2 sessions). Missing data was minimal, and no adverse events related to the study were reported. Acceptability was high as veterans were satisfied with the wearables and valued the health coaching support. Conclusions: This pilot study provides insights into the feasibility of a large-scale randomized control trial that promotes meditation and physical activity to augment cognitive control to facilitate self-regulation. Future efforts should expand recruitment strategies and add internal data quality monitoring. Trial registration: NCT04164667, retrospectively registered November 12, 2019, https://clinicaltrials.gov/study/NCT04164667