Testing a Mindfulness/Acceptance-Based Smartphone App for Nurses Impacted by the COVID-19 Pandemic

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Mindfulness/Acceptance-Based Smartphone App (MABSA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention Group<br>The intervention is 6 weeks in duration. Participants will be asked to listen daily to at least one audio-guided mindfulness meditation embedded in the app. They will also be asked to watch a weekly video lesson on mindfulness and acceptance and will be asked to write a reflection about the video. They will also receive weekly emotional and technical support during the duration of the intervention. | Behavioral: Mindfulness/Acceptance-Based Smartphone App (MABSA)<br>* This is a mindfulness- and acceptance-based smartphone app. The mindfulness and acceptance exercises embedded in the app are based on the principles of Acceptance and Commitment Therapy. Participants in the intervention group will be using the app for 6 weeks. They are expected to access the meditations and mindfulness exercises within the app on a daily basis.<br>|
| No Intervention: Wait-List Control Group<br>The control group is a wait-list control group. Participants in the control group will be offered to use the app after 10 weeks of being in the study. The control group participants once they opted to use the app after 10 weeks will only have access to the app for 6 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder Symptoms (PTSD Checklist for DSM-5 or also called PCL-20) | Changes in posttraumatic stress disorder (PTSD) symptoms based on the PTSD Checklist for DSM-5 (PCL-20). There are 20 items in the PCL-20. The minimum value of PCL-20 is 0, and the maximum value is 80. Higher scores mean a worse outcome (more severe symptoms of Posttraumatic Stress Disorder). | The investigator will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up | 
| Resilience (Connor-Davidson Resilience Scale or also called CD-RISC-25) | Changes in resilience based on the Connor-Davidson Resilience Scale (CD-RISC-25). There are 25 items in the CD-RISC-25. The minimum value of CD-RISC-25 is 0, and the maximum value is 100. Higher scores mean a better outcome (higher level of resilience). | 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 | 
| Mindfulness (Mindfulness Attention and Awareness Scale or also called MAAS) | Changes in mindfulness based on the Mindfulness Attention and Awareness Scale (MAAS). There are 15 items in the MAAS. The minimum value of MAAS is 15, and the maximum value is 90. Higher scores mean a better outcome (higher level of mindfulness). | 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 | 
| Experiential Avoidance (Acceptance and Action Questionnaire or also called AAQ) | Changes in experiential avoidance based on the Acceptance and Action Questionnaire (AAQ). There are 7 items in the AAQ. The minimum value of the AAQ is 7, and the maximum value is 49. Higher scores mean a worse outcome (higher level of experiential avoidance or the unwillingness to be present with difficult emotions and thoughts). | 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 | 
| Rumination (Rumination Response Scale or also called RRS) | Changes in rumination based on the Rumination Response Scale (RRS). The RRS has 22 items. The minimum value of the RRS is 22, and the maximum value is 88. Higher scores mean a worse outcome (higher level of rumination or perseverative and passive focus on symptoms and the possible causes and outcomes of psychological distress) | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder Recovery (Abbreviated Version of the Posttraumatic Stress Disorder Checklist or also called PCL-8) | Daily measures of posttraumatic stress disorder (PTSD) using the abbreviated PTSD Checklist for DSM-5 (PCL-8). The PCL-8 is a shortened version of the PCL-20. There are 8 items in the PCL-8. The minimum value is 0, and the maximum value is 32. Higher scores mean a worse outcome (greater severity of Posttraumatic Stress Disorder symptoms). | The investigator will measure posttraumatic stress disorder symptoms daily using the app (ecological momentary assessment). | 
| Resilience Progression (Abbreviated Version of the Connor-Davidson Resilience Scale or also called CD-RISC-10) | Daily measures of resilience using the abbreviate Connor-Davidson Resilience Scale 10 (CD-RISC-10). There are 10 items in the CD-RISC-10. The minimum value of the CD-RISC-10 is 0, and the maximum value is 40. Higher scores mean a better outcome (higher level of resilience). | The investigator will measure resilience daily using the app (ecological momentary assessment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posttraumatic stress disorder, mindfulness, COVID-19, mindfulness app