Trial Outcomes & Findings for Using Mobile Technology to Address the Trauma Mental Health Treatment Gap (NCT NCT05374408)
NCT ID: NCT05374408
Last Updated: 2025-09-09
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
29 participants
Primary outcome timeframe
5 months
Results posted on
2025-09-09
Participant Flow
no pre-assignment details to report
Participant milestones
| Measure |
Aim 1: Participant Focus Group
Participants who are receiving care at one of the designated integrated care clinics will participate in focus groups using semi-structured interviews to provide feedback about BBN along with educational materials to inform any changes needed prior to deployment of the app and education for Aim 2.
|
Aim 1: Behavioral Health Provider Aim 1
semi-structured interviews will be conducted among BHPs at one of the designated clinics to review the educational materials prepared for BBN deployment.
|
Aim 2: BounceBack Now (BBN) Participants
Deployment of BounceBack Now (BBN) for self-paced participant use
BounceBack Now (BBN) for Trauma Informed Care: 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.
|
BHPS, Clinical Staff, Admin Aim 2
BHPS, Clinical Staff, Administrative Staff at one of the designated Integrated Care Clinic
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
2
|
12
|
10
|
|
Overall Study
COMPLETED
|
5
|
2
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The gender was not collected for the BHP group
Baseline characteristics by cohort
| Measure |
Aim 1 BounceBack Now (BBN) Participants
n=5 Participants
Patients recruited to participate to in focus groups provide feedback about BBN and educational materials prior to app deployment..
|
Aim 1 BounceBack Now (BBN) Behavioral Health Provider
n=2 Participants
BHPs were recruited to participate to in focus groups provide feedback about BBN and educational materials prior to app deployment
|
Aim 2 BounceBack Now (BBN) Participants
n=12 Participants
Feasibility of integrating the BBN app into care
BounceBack Now (BBN) for Trauma Informed Care: 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 2 BounceBack Now (BBN) BHPs, Clinical Staff, Admin and Providers
n=10 Participants
BHPs, Clinical Staff, Admin and Providers were recruited to participate in focus groups to provide feedback about app use within the clinical setting.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=29 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
12 Participants
n=12 Participants
|
10 Participants
n=10 Participants
|
29 Participants
n=29 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=29 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants • The gender was not collected for the BHP group
|
—
|
11 Participants
n=12 Participants • The gender was not collected for the BHP group
|
—
|
14 Participants
n=17 Participants • The gender was not collected for the BHP group
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants • The gender was not collected for the BHP group
|
—
|
1 Participants
n=12 Participants • The gender was not collected for the BHP group
|
—
|
3 Participants
n=17 Participants • The gender was not collected for the BHP group
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • race was not collected for the BHPS
|
—
|
1 Participants
n=12 Participants • race was not collected for the BHPS
|
—
|
1 Participants
n=17 Participants • race was not collected for the BHPS
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • race was not collected for the BHPS
|
—
|
0 Participants
n=12 Participants • race was not collected for the BHPS
|
—
|
0 Participants
n=17 Participants • race was not collected for the BHPS
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • race was not collected for the BHPS
|
—
|
0 Participants
n=12 Participants • race was not collected for the BHPS
|
—
|
0 Participants
n=17 Participants • race was not collected for the BHPS
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants • race was not collected for the BHPS
|
—
|
2 Participants
n=12 Participants • race was not collected for the BHPS
|
—
|
4 Participants
n=17 Participants • race was not collected for the BHPS
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants • race was not collected for the BHPS
|
—
|
6 Participants
n=12 Participants • race was not collected for the BHPS
|
—
|
9 Participants
n=17 Participants • race was not collected for the BHPS
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • race was not collected for the BHPS
|
—
|
1 Participants
n=12 Participants • race was not collected for the BHPS
|
—
|
1 Participants
n=17 Participants • race was not collected for the BHPS
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • race was not collected for the BHPS
|
—
|
2 Participants
n=12 Participants • race was not collected for the BHPS
|
—
|
2 Participants
n=17 Participants • race was not collected for the BHPS
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
2 participants
n=2 Participants
|
12 participants
n=12 Participants
|
10 participants
n=10 Participants
|
29 participants
n=29 Participants
|
PRIMARY outcome
Timeframe: 5 monthsEducational 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.
Outcome measures
| Measure |
BounceBack Now (BBN) Participants
n=5 Participants
Deployment of BounceBack Now (BBN) for self-paced participant use
BounceBack Now (BBN) for Trauma Informed Care: 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) Behavioral Health Provider
n=2 Participants
Feasibility of integrating the BBN app into care
BounceBack Now (BBN) for Trauma Informed Care: 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: Evaluation of Educational Materials
Acceptability
|
3 Participants
|
2 Participants
|
|
Aim 1: Evaluation of Educational Materials
Usability
|
4 Participants
|
2 Participants
|
|
Aim 1: Evaluation of Educational Materials
Feasibility
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 8 monthsFeasibility 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.
Outcome measures
| Measure |
BounceBack Now (BBN) Participants
n=4 Participants
Deployment of BounceBack Now (BBN) for self-paced participant use
BounceBack Now (BBN) for Trauma Informed Care: 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) Behavioral Health Provider
n=10 Participants
Feasibility of integrating the BBN app into care
BounceBack Now (BBN) for Trauma Informed Care: 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 2: Feasibility
App Specific Adoption Challenges
|
3 Participants
|
3 Participants
|
|
Aim 2: Feasibility
Benefits of Use
|
4 Participants
|
10 Participants
|
|
Aim 2: Feasibility
Need for System Buy In
|
2 Participants
|
7 Participants
|
|
Aim 2: Feasibility
Systemic App Adoption Challenges
|
2 Participants
|
8 Participants
|
|
Aim 2: Feasibility
Implementation Challenges
|
4 Participants
|
8 Participants
|
|
Aim 2: Feasibility
Provider Specific Challenges
|
1 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 8 monthsPopulation: A total of 12 participants downloaded the app. N of 6 used the app for the duration of the study.
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.
Outcome measures
| Measure |
BounceBack Now (BBN) Participants
n=12 Participants
Deployment of BounceBack Now (BBN) for self-paced participant use
BounceBack Now (BBN) for Trauma Informed Care: 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) Behavioral Health Provider
Feasibility of integrating the BBN app into care
BounceBack Now (BBN) for Trauma Informed Care: 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 2: Acceptability: App Use
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: 8 monthsPopulation: All participants (N=6) who completed the intervention and provided responses to the mHealth App Usability Questionnaire (MAUQ) at the post-intervention time point were included in the analysis. Responses marked as "Not Applicable" (NA) on individual items were excluded from the participant-level total score calculations. No participants were excluded from the analysis population.
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.
Outcome measures
| Measure |
BounceBack Now (BBN) Participants
n=6 Participants
Deployment of BounceBack Now (BBN) for self-paced participant use
BounceBack Now (BBN) for Trauma Informed Care: 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) Behavioral Health Provider
Feasibility of integrating the BBN app into care
BounceBack Now (BBN) for Trauma Informed Care: 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 2:Usability
|
113.8 score on a scale
Standard Deviation 6.7
|
—
|
PRIMARY outcome
Timeframe: 8 monthsPatient 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.
Outcome measures
| Measure |
BounceBack Now (BBN) Participants
n=6 Participants
Deployment of BounceBack Now (BBN) for self-paced participant use
BounceBack Now (BBN) for Trauma Informed Care: 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) Behavioral Health Provider
Feasibility of integrating the BBN app into care
BounceBack Now (BBN) for Trauma Informed Care: 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 2: Patient Burden
|
4.17 score on a scale
Standard Deviation 5.74
|
—
|
Adverse Events
BounceBack Now (BBN) Participants Aim 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BounceBack Now (BBN) Behavioral Health Provider Aim 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BounceBack Now Participants Aim 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BounceBack Now Aim 2 BHPs, Clinical Staff, Providers, Admin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place