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

NCT ID: NCT04861311

Last Updated: 2021-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-06-30

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 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.

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. 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.

Conditions

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Posttraumatic Stress Disorder

Keywords

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Posttraumatic Stress Disorder, mindfulness, acceptance, resilience

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention Group

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.

Group Type EXPERIMENTAL

Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention

Intervention Type BEHAVIORAL

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.

Wait-List Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nevada, Las Vegas

OTHER

Sponsor Role lead

Responsible Party

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Andrew Thomas Reyes

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew T Reyes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nevada, Las Vegas

Central Contacts

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Andrew T Reyes, PhD

Role: CONTACT

Phone: 702-895-5094

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 32248935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33280672 (View on PubMed)

Other Identifiers

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1603895-3

Identifier Type: -

Identifier Source: org_study_id