CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
Aim 2: BounceBack Now (BBN) for Trauma Informed Care Deployment +4 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT05374408
NCT05374408N/ACompleted

IDeA-CTR-Using Mobile Technology to Address the Trauma Mental Health Treatment Gap in Primary Care: Developing Implementation Protocols for Primary Care

University of Nebraska·observational·Posted May 16, 2022·Updated Sep 9, 2025

In Brief

An observational study evaluating Aim 2: BounceBack Now (BBN) for Trauma Informed Care Deployment, Aim 1 Participant Focus Groups, and 3 other interventions for Post Traumatic Stress Disorder. Completed, enrolled 29 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 16, 2022
Enrollment StartAug 3, 2022
Primary CompletionMar 22, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.1 years ago

Interventions

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

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.

Aim 1 Participant Focus Groupsbehavioral

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.

Aim 1 BHP Focus Groupsbehavioral

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.

Aim 2: BHP, Provider, Staff and Admin Focus Groupsbehavioral

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.

Aim 2 : Participant Focus Groupbehavioral

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