Testing the Efficacy of a Mindfulness- and Acceptance-Based Smartphone App for PTSD: A Randomized Controlled Trial

Posttraumatic Stress Disorder Clinical Trial

Official title:

Testing the Efficacy of a Mindfulness- and Acceptance-Based Smartphone App Intervention for College Student Veterans With Posttraumatic Stress Disorder (PTSD): A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04861311
• Other study ID #: 1603895-3
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2021
• Source: University of Nevada, Las Vegas
• Contact: Andrew T Reyes, PhD
• Phone: 702-895-5094
• Email: andrewthomas.reyes[@]unlv.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to test the feasibility and acceptability of a mindfulness- and acceptance-based smartphone app (MABSA) intervention for college student veterans with posttraumatic stress disorder (PTSD) symptoms. The study will use a randomized controlled trial design of two groups: intervention group of about 30 participants with PTSD and 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.

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. We previously developed the MABSA and pilot tested it in a single-arm study. 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). We will obtain qualitative feedback on program content and format through a pilot test of the prototype with a group of eligible college student veterans (N = 4). Upon revising the intervention based on participants' feedback, we 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 college student veterans: (1) the MABSA intervention group (N = 30) and the waitlist control group (N = 30). Upon collecting the data on recruitment, retention, adherence, intervention satisfaction, and app usability, we 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• (1) aged 18 years old or older, (2) currently registered as an undergraduate or graduate student, (3) has previous active military service from any U.S. military service branch, (4) has at least daily access to their own Apple iPhone (version 5 or later) or Android phone, and (5) 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) Those who have a cognitive impairment such as dementia-related disorders.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention
The intervention is based on the principles of Acceptance and Commitment Therapy (ACT). Therefore, the intervention is an ACT-based smartphone app delivered for 6 weeks in which participants will be applying the mindfulness and acceptance exercises embedded in the app. The mindfulness and acceptance exercises are audio-guided mindfulness meditations and video lessons about ACT.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

References & Publications (2)

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. — View Citation

Reyes AT, Serafica R, Sojobi A. College student veterans' experience with a mindfulness- and acceptance-based mobile app intervention for PTSD: A qualitative study. Arch Psychiatr Nurs. 2020 Dec;34(6):497-506. doi: 10.1016/j.apnu.2020.09.005. Epub 2020 Sep 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention Satisfaction	Satisfaction with the intervention particularly on the areas of: overall satisfaction, perceived helpfulness, comprehension, intentions to use, and perceived fit	We will measure intervention satisfaction at mid-intervention (Week 3) and post-intervention (Week 6)
Other	System Usability	Perceived usability of the app using the System Usability Scale	We will measure perceived usability of the app at mid-intervention (Week 3) and post-intervention (Week 6)
Primary	PTSD	Changes in posttraumatic stress disorder (PTSD) symptoms based on the PTSD Checklist for DSM-5 (PCL-5)	We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Primary	Resilience	Changes in resilience based on the Connor-Davidson Resilience Scale 25	We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Primary	Mindfulness	Changes in mindfulness based on the Mindfulness Attention and Awareness Scale	We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Primary	Experiential Avoidance	Changes in experiential avoidance based on the Acceptance and Action Questionnaire	We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Primary	Rumination	Changes in rumination based on the Rumination Scale	We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Secondary	PTSD Recovery	Daily measures of PTSD using the abbreviated PTSD Checklist for DSM-5	We will measure PTSD daily using the app (ecological momentary assessment)
Secondary	Resilience Progression	Daily measures of resilience using the abbreviate Connor-Davidson Resilience Scale 10	We will measure resilience daily using the app (ecological momentary assessment)