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. 2022 Mar 29:10.1089/tmj.2021.0612.
doi: 10.1089/tmj.2021.0612. Online ahead of print.

Synchronous Telehealth Yoga and Cognitive Processing Group Therapies for Women Veterans with Posttraumatic Stress Disorder: A Multisite Randomized Controlled Trial Adapted for COVID-19

Belle Zaccari  1   2   3 , Jennifer M Loftis  2   3   4 , Terri Haywood  5   6 , Kimberly Hubbard  7 , Jennifer Clark  8 , Ursula Ann Kelly  6   9
Affiliations

Synchronous Telehealth Yoga and Cognitive Processing Group Therapies for Women Veterans with Posttraumatic Stress Disorder: A Multisite Randomized Controlled Trial Adapted for COVID-19

Belle Zaccari et al. Telemed J E Health. .

Abstract

Background: Providing care over telehealth grew slowly until the COVID-19 pandemic. Since the onset of the COVID-19 pandemic, providing mental health care was readily adapted to virtual means; however, clinical trial research is nascent in adapting methods and procedures to the virtual world. Methods: We present protocol modifications to pivot a multisite randomized controlled trial study, conducted at Southeastern and Pacific Northwestern Veterans Affairs Health Care Systems, from being conducted in-person to virtually, following the onset of the COVID-19 pandemic. We measured outcomes of posttraumatic stress disorder (PTSD) symptoms and psychophysiological markers of stress among female Veterans with PTSD secondary to military sexual trauma. We collected qualitative data about provider and participant experiences with telehealth. Results: Across sites, 200 participants were consented (48 virtually), 132 were randomized (28 to virtual groups), and 117 completed data collection and treatment (69 completed all or some data collection or treatment virtually). Conclusions: The pivots made for this study were in response to the COVID-19 pandemic and offer innovative procedures leveraging technology and contributing to the broader landscape of conducting research virtually. Clinical Trials Number: NCT02640690.

Keywords: COVID adaptation; Veteran; group therapy; protocol; synchronous telehealth; telemedicine.

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Figures

Fig. 1.
Fig. 1.
Timeline of events for the multisite RCT study conducted at SE and Pacific NW and VA Health Care Systems. Trials began in March 2016 at the SE site. Eight cohorts were conducted between March 2016 and February 2020 when the Pacific NW site was approved by the IRB to begin recruitment. In February 2020, recruitment for cohort one at the Pacific NW site coincided with completing cohort eight and enrolling cohort nine at the SE site. In March 2020, COVID-19 shutdowns occurred and study was converted to virtual format. In July 2021, interventions were completed at both sites. IRB, Institutional Review Boards; NW, Northwestern; RCT, randomized controlled trial; SE, Southeastern; VA, Veterans affairs.
Fig. 2.
Fig. 2.
Virtual informed consent and enrollment procedures for virtual study implementation in the present study. Contact 1 included determining phone screen eligibility and interest in participating, sending ICDs through mail and encrypted email, and scheduling a phone call to review the ICDs. Contact 2 included a phone call for informed consent, sending additional ICDs as necessary, and providing instructions for returning signed ICDs through mail or drive-through drop-off. In contact 3, the signed ICDs were received by the study team, a copy was provided to the participant, the in-depth screen was scheduled, and a link to surveys was sent through email. Contact 4 included the in-depth screening process using video teleconference, determining final eligibility following the scoring of screening measures, and sending an additional link to participants for data entry through email. In contact 5, eligible participants were scheduled for their baseline data collection appointment. ICDs, informed consent documents.
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