Using Mobile Technology to Address the Trauma Mental Health Treatment Gap
Part of paid clinical trials in Omaha, Nebraska.
- Sponsor
- University of Nebraska
- Study ID
- NCT05374408
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Aim 2: BounceBack Now (BBN) for Trauma Informed Care Deployment — BEHAVIORALBrief 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.
- Aim 1 Participant Focus Groups — BEHAVIORALAt 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.
- Aim 1 BHP Focus Groups — BEHAVIORALAt 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.
- Aim 2: BHP, Provider, Staff and Admin Focus Groups — BEHAVIORALSemi-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.
- Aim 2 : Participant Focus Group — BEHAVIORALSemi-structured interviews will be conducted with Participants to assess the feasibility, acceptability, and usability of BBN.
Study Details
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.
Key Dates
- Start date
- Aug 3, 2022
- Status verified
- Jun 2025
- Primary completion
- Mar 22, 2024
- Completion
- Mar 22, 2024
Study Design
- Enrollment
- 29 participants (actual)
Arms
- Arm: BounceBack Now (BBN) Participants Aim 1Participants who are receiving care at one of the designated integrated care clinics.
- Arm: BounceBack Now (BBN) Behavioral Health Provider Aim 1Behavioral Health Providers who serve as a BHP at one of the designated integrated care clinics.
- Arm: BounceBack Now (BBN) Participants Aim 2Participants who are receiving care at a designated integrated care clinic
- Arm: Bounce Back Now (BBN) Aim 2 BHPs, Clinical Staff, Providers, and AdministrationClinical 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.
Primary Outcome Measure
Aim 1: Evaluation of Educational Materials [ Time Frame: 5 months ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Nebraska Medical Center-Fontenelle Clinic | Omaha | Nebraska | 68104 | - |
| Nebraska Medical Center-Midtown Clinic | Omaha | Nebraska | 68131 | - |
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