Using Mobile Technology to Address the Trauma Mental Health Treatment Gap

NCT05374408 | Completed Results

• 1 other identifier: 0178-21-EP
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

BounceBack Now (BBN) is a self-help, trauma-focused mental health mobile application (app) with automated assessment with treatment guidance and in-app evidence-based treatment support for depression, post-traumatic stress disorder (PTSD), sleep difficulties, and anxiety. BBN contains many of the necessary components to promote self-management of these conditions. Investigators will evaluate the app's feasibility and acceptability among under served participants (e.g., African Americans and participants with lower socioeconomic status) with trauma histories in an integrated primary care (IPC) setting. There are two specific aims: 1) to develop educational materials for patients and behavioral health providers for BBN in IPC, and 2) to conduct a pilot trial of BBN for participants with trauma histories in an IPC setting. For Aim 1, focus groups with behavioral health providers and participants will be conducted to obtain feedback about BBN and training materials. For Aim 2, a feasibility study with 15 participants will be conducted to identify and address any procedural issues and to refine the protocol before conducting the full-scale study.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (5)

• Aim 1: Evaluation of Educational Materials

  Educational Materials that have been developed related to using a trauma related mobile app will be evaluated by focus groups comprised of Patients and BHPs. The participants will be asked to use a think aloud approach using semi-structured interviews in order to determine the acceptability, usability and feasibility of the materials using questions developed to evaluate these items assessed during the focus group.

  5 months

• Aim 2: Feasibility

  Feasibility will be assessed using semi-structured interviews. BHPs, Clinical Staff, Providers, Administration and Patients will complete semi-structured interviews guided by the Integrated Promoting Action on Research Implementation in Health Services Framework.

  8 months

• Aim 2: Acceptability: App Use

  Acceptability will also be measured by the number of patients who have downloaded and used the app for the duration of the 6 week study time-frame.

  8 months

• Aim 2:Usability

  Patient usability of the app will be assessed using the 18-item mHealth App Usability Questionnaire (MAUQ). In this questionnaire each item is rated from 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree. Scale Max= 126. Scale Min= 18 To determine the usability of an app, calculate the total and determine the average of the responses to all of the 18 statements. The higher the overall average, the higher the usability of the app.

  8 months

• Aim 2: Patient Burden

  Patient acceptability, patients will complete the 20-item User Burden Scale at both follow-up visits. The scale has shown good overall inter-item reliability, convergent validity, and concurrent validity. The User Burden Scale (UBS) is a 20-item instrument used to assess perceived burden from digital health technologies across domains such as difficulty of use, time, physical demand, privacy, guilt, and financial burden. Each item is scored from 0 (Not at all) to 4 (Extremely), with total scores ranging from 0 (minimum) to 80 (Maximum). Higher scores indicate greater burden.

  8 months

Study Arms (4)

BounceBack Now (BBN) Participants Aim 1

Participants who are receiving care at one of the designated integrated care clinics.

Behavioral: Aim 1 Participant Focus Groups

BounceBack Now (BBN) Behavioral Health Provider Aim 1

Behavioral Health Providers who serve as a BHP at one of the designated integrated care clinics.

Behavioral: Aim 1 BHP Focus Groups

BounceBack Now (BBN) Participants Aim 2

Participants who are receiving care at a designated integrated care clinic

Behavioral: Aim 2: BounceBack Now (BBN) for Trauma Informed Care Deployment; Behavioral: Aim 2 : Participant Focus Group

Bounce Back Now (BBN) Aim 2 BHPs, Clinical Staff, Providers, and Administration

Clinical staff, Behavioral Health Providers, Providers, and Administration staff who can provide feedback pertaining to the factors that contribute to app deployment in an integrated care setting.

Behavioral: Aim 2: BHP, Provider, Staff and Admin Focus Groups

Interventions

Aim 2: BounceBack Now (BBN) for Trauma Informed Care Deployment BEHAVIORAL

Brief explanation of BounceBack Now (BBN) will be provided. Participants will be directed to areas of the application that are congruent with treatment focus identified during their standard of care appointment. Participants will complete a baseline survey by either going online or being contacted by a member of the investigational team. The investigative assistant will contact all participants in 2-3 days to help the participant navigate the BBN and complete the baseline survey, if needed. The participant will continue to meet with their behavioral health provider (BHP) as determined by the standard of care interactions. BHP will highlight features contained in BBN for participant to use in between appointments. Follow-up phone calls will be scheduled for 2 weeks and 6 weeks after initial visit. During these phone- calls the participant will be contacted by a member of the investigational team to complete follow-up surveys.

BounceBack Now (BBN) Participants Aim 2

Aim 1 Participant Focus Groups BEHAVIORAL

At the beginning of the focus group the patients will be asked to download BBN on their smartphone device with the assistance of the research team, if they have not already done so. A basic tutorial of the BBN and the developed educational materials will be conducted/reviewed with the participants. After the tutorial and education has been provided the participants will be asked to try some of major features of the app. Then, they will be asked to review the patient education materials. They will be asked to discuss strengths and weaknesses of the materials. They will be also asked whether there is any content missing from the education material.

BounceBack Now (BBN) Participants Aim 1

Aim 1 BHP Focus Groups BEHAVIORAL

At the beginning of the focus group the BHPs will be asked to download BBN on their smartphone device with the assistance of the research team, if they have not already done so. A basic tutorial of the BBN and the developed educational materials will be conducted/reviewed with the BHPs. After the tutorial and education has been provided the participants will be asked to try some of major features of the app. Then, they will be asked to review the patient education materials. They will be asked to discuss strengths and weaknesses of the materials. They will be also asked whether there is any content missing from the education material.

BounceBack Now (BBN) Behavioral Health Provider Aim 1

Aim 2: BHP, Provider, Staff and Admin Focus Groups BEHAVIORAL

Semi-structured interviews will be conducted with BHPs, Clinical Staff, Providers and Administration They will ask questions to BHPs, Clinical Staff, Providers and Administration about feasibility, acceptability, and usability of BBN and overall clinical protocol.

Bounce Back Now (BBN) Aim 2 BHPs, Clinical Staff, Providers, and Administration

Aim 2 : Participant Focus Group BEHAVIORAL

Semi-structured interviews will be conducted with Participants to assess the feasibility, acceptability, and usability of BBN.

BounceBack Now (BBN) Participants Aim 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with a trauma related disorder and behavioral health providers (BHPs) which are Clinical staff, providers and administration

You may qualify if:

• Behavioral Health Providers:
• 19 years and older
• Participants:
• years and older
• Newly referred to a behavioral health provider at the Fontanelle or Midtown Clinic
• Own a smart phone

You may not qualify if:

• Behavioral Health Providers:
• 18 years and younger
• Participants:
• years and younger
• Referred to a behavioral health provider in the past year
• Does not own a smart phone
• Score 2 points or lower on the Adverse Childhood Experience screening
• High suicidality based on a clinical assessment by the behavioral health provider
• Having neurocognitive conditions either assessed by a primary care provider or diagnostic code for neurocognitive condition found in the patient note or Electronic Health Record (EHR)

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (2)

Nebraska Medical Center-Fontenelle Clinic

Omaha, Nebraska, 68104, United States

Location

Nebraska Medical Center-Midtown Clinic

Omaha, Nebraska, 68131, United States

Location

Related Publications (3)

• Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500.

  PMID: 30973342 BACKGROUND

• Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012 Oct;27(10):1361-7. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23.

  PMID: 22618581 BACKGROUND

• Stetler CB, Damschroder LJ, Helfrich CD, Hagedorn HJ. A Guide for applying a revised version of the PARIHS framework for implementation. Implement Sci. 2011 Aug 30;6:99. doi: 10.1186/1748-5908-6-99.

  PMID: 21878092 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Margaret Emerson
• Organization: UNMC

margaret.emerson@unmc.edu

4025596625

Study Officials

• Margaret R Emerson, DNP, APRN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 16, 2022
• Study Start: August 3, 2022
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)