Clinical trial NCT05157035: Testing a Mindfulness/Acceptance-Based Smartphone App for Nurses Impacted by the COVID-19 Pandemic
Official title: Testing a Mindfulness/Acceptance-Based Smartphone App Intervention to Develop Resilience Among Nurses Traumatized From the Effects of the COVID-19 Pandemic: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Posttraumatic Stress Disorder
Keywords: posttraumatic stress disorder
mindfulness
COVID-19
mindfulness app
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention Group will use the smartphone app which comprises of audio-guided mindfulness meditations and video lessons. Participants are asked to listen to at least one guided meditation daily and watch one video lesson each week. Participants will also receive a weekly phone call for emotional and technical support. The wait-list control group will have the option to use the app-based intervention after 10 weeks of being in the control group.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test the feasibility and acceptability of a mindfulness- and acceptance-based smartphone app (MABSA) intervention for frontline nurses emotionally and psychologically impacted by the COVID-19 pandemic. The study will use a randomized controlled trial design of two groups: an intervention group of about 30 participants with posttraumatic stress symptoms and a wait-list control group of about 30 participants. The duration of the MABSA intervention is 6 weeks. The following are the outcomes to be measured: resilience, PTSD, mindfulness, experiential avoidance, and rumination.

Detailed description: The objective of the proposed study is to evaluate the feasibility of the Mindfulness/Acceptance-Based Smartphone App (MABSA) intervention in a randomized controlled trial (RCT) environment and to obtain generalized information (i.e., initial efficacy, recruitment, retention, adherence, satisfaction, and usability of the refined intervention). The expected results will provide the foundation for a prospective, fully powered, larger-scale RCT study. The investigator previously developed the MABSA and pilot-tested it in a single-arm study among veterans, and the study will be testing the app among nurses who have been emotionally and psychologically impacted by the COVID-19 pandemic. Our central hypothesis is that the refined MABSA intervention would improve intervention satisfaction, app usability, and adherence and positively affect resilience, PTSD, mindfulness, experiential avoidance, and rumination. The specific aims of the proposed study are outlined below.

AIM 1: To refine the previously developed MABSA intervention. The 6-week smartphone-delivered program will involve (1) daily audio-guided meditations on various mindfulness and acceptance exercises constructed based on the principles of acceptance and commitment therapy; (2) weekly support and feedback through phone calls and/or texting the intervention facilitators; and (3) ecological momentary assessment (daily monitoring of PTSD and resilience) to monitor the progression of treatment response (i.e., the trajectory of resilience and PTSD recovery). The investigator will obtain qualitative feedback on program content and format through a pilot test of the prototype with a group of eligible nurses (N = 4). Upon revising the intervention based on participants' feedback, the investigator will develop the intervention protocol manual for the RCT.

AIM 2: To test the feasibility and acceptability of the refined MABSA intervention in a small-scale RCT for a prospective, fully powered, larger-scale RCT study. The small-scale RCT study will involve the following two groups of frontline nurses: (1) the MABSA intervention group (N = 30) and the wait-list control group (N = 30). Upon collecting the data on recruitment, retention, adherence, intervention satisfaction, and app usability, the study will determine the preliminary efficacy based on the following five outcomes: resilience, PTSD, mindfulness, experiential avoidance, and rumination. Qualitative feedback on the facilitators of and challenges to recruitment, retention, and adherence will be collected via exit interviews.

Eligibility criteria: Inclusion Criteria:

* (1) aged 18 years old or older, (2) frontline registered nurse or licensed practical nurse practising in the United States, (3) has at least daily access to their own Apple iPhone (version 5 or later) or Android phone, and (4) have posttraumatic stress disorder (PTSD) symptoms (must have a score of 33 or above on the PTSD Checklist for DSM-5)

Exclusion Criteria:

* (1) Those who have a score of 32 or below on the PTSD Checklist for DSM-5, and (2) healthcare workers that are not RNs or LPNs

Primary outcomes:
measure: Posttraumatic Stress Disorder Symptoms (PTSD Checklist for DSM-5 or also called PCL-20)
timeFrame: The investigator will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
measure: Resilience (Connor-Davidson Resilience Scale or also called CD-RISC-25)
timeFrame: The investigator will measure resilience (Connor-Davidson Resilience Scale, CD-RISC-25) at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
measure: Mindfulness (Mindfulness Attention and Awareness Scale or also called MAAS)
timeFrame: The investigator will measure mindfulness (Mindfulness Attention and Awareness Scale, MAAS) at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
measure: Experiential Avoidance (Acceptance and Action Questionnaire or also called AAQ)
timeFrame: The investigator will measure experiential avoidance (Acceptance and Action Questionnaire, AAQ) at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
measure: Rumination (Rumination Response Scale or also called RRS)
timeFrame: The investigator will measure rumination (Rumination Response Scale, RRS) at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Secondary outcomes:
measure: Posttraumatic Stress Disorder Recovery (Abbreviated Version of the Posttraumatic Stress Disorder Checklist or also called PCL-8)
timeFrame: The investigator will measure posttraumatic stress disorder symptoms daily using the app (ecological momentary assessment).
measure: Resilience Progression (Abbreviated Version of the Connor-Davidson Resilience Scale or also called CD-RISC-10)
timeFrame: The investigator will measure resilience daily using the app (ecological momentary assessment)
Other outcomes:
measure: Intervention Satisfaction (Intervention Satisfaction Survey or also called ISS).
timeFrame: The investigator will measure intervention satisfaction at mid-intervention (Week 3) and post-intervention (Week 6)
measure: Usability of the App (System Usability Scale or also called SUS)
timeFrame: The investigator will measure perceived usability of the app at mid-intervention (Week 3) and post-intervention (Week 6)
Locations:
Study officials:
References:
citation: Reyes AT. The Process of Learning Mindfulness and Acceptance through the Use of a Mobile App Based on Acceptance and Commitment Therapy: A Grounded Theory Analysis. Issues Ment Health Nurs. 2022 Jan;43(1):3-12. doi: 10.1080/01612840.2021.1953652. Epub 2021 Aug 4.
citation: Reyes AT, Song H, Bhatta TR, Kearney CA. Exploring the relationships between resilience, mindfulness, and experiential avoidance after the use of a mindfulness- and acceptance-based mobile app for posttraumatic stress disorder. Perspect Psychiatr Care. 2022 Apr;58(2):776-784. doi: 10.1111/ppc.12848. Epub 2021 May 20.
citation: Reyes AT. A Mindfulness Mobile App for Traumatized COVID-19 Healthcare Workers and Recovered Patients: A Response to "The Use of Digital Applications and COVID-19". Community Ment Health J. 2020 Oct;56(7):1204-1205. doi: 10.1007/s10597-020-00690-9. Epub 2020 Aug 9. No abstract available.
citation: Reyes AT, Bhatta TR, Muthukumar V, Gangozo WJ. Testing the acceptability and initial efficacy of a smartphone-app mindfulness intervention for college student veterans with PTSD. Arch Psychiatr Nurs. 2020 Apr;34(2):58-66. doi: 10.1016/j.apnu.2020.02.004. Epub 2020 Feb 18.