Using Mobile Technology to Address the Trauma Mental Health Treatment Gap

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05374408
• Other study ID #: 0178-21-EP
• Status: Completed
• Phase: N/A
• Start date: August 3, 2022
• Est. completion date: March 22, 2024

Study information

• Verified date: April 2024
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

BounceBack Now (BBN) is a self-help, trauma-focused mental health mobile 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. We will evaluate the apps feasibility and acceptability among underserved patients (e.g., African Americans and patient 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 patients with trauma histories in an IPC setting. To achieve Aim 1, we will conduct focus groups with behavioral health providers and patients to obtain feedback about BBN and training materials. For Aim 2, a feasibility study with 15 patients will be conducted to identify and address any procedural issues and to refine the protocol before conducting the full-scale study.

Description:

BounceBack Now (BBN), is a Trauma Focused Mobile App. After consent has been completed that BHP will assist the participant in downloading BBN onto their smartphone device. The current BBN structure contains a brief assessment and multiple treatment components for disorders that are frequently associated with traumatic event exposure. A brief assessment based on the Kessler 6 will be completed, based on this assessment the participants are then guided to treatment recommendations with an interactive rationale for each treatment. Education/explanations are provided in written, spoken, and animated video formats. Given that each of these treatments may be beneficial for patients with subsyndromal or very minor symptoms, all patients are able to see and interact with all treatment components, but it is anticipated that BHPs will provide recommendations for the sections that will be most beneficial. The treatment components are each based on effective in-person interventions. These include behavioral activation (depression), Written Exposure Therapy, and Expressive Writing (PTSD), Cognitive Behavioral Therapy for Sleep, and Relaxation/Mindfulness (stress/anxiety). The corresponding app sections are titled Activate, Write, Sleep, and Coping Tools, respectively. Each of these sections contains education components and there is a separate education component for the app overall that can be found through the coping tools page.

Aim 1: Develop educational materials for patients and Behavioral Health Providers (BHPs) for BBN in IPC Researchers will present the educational materials and BBN in focus groups. These focus groups may be conducted virtually (i.e., zoom call) or in-person. The focus group will last 30 - 60 minutes. Focus groups will focus on acceptability, feasibility, and usability of the materials and the education materials and the app.

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. 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. Finally, they will be asked to assess usability of the material. At the completion of the focus group the research team will assist the participants in removing BBN from their phones.

As for the provider focus group, a similar process will be used to ask about the provider educational materials and patient educational materials. We will also collect the following information including gender, age, job, years in practice, and years at the clinic.

Focus groups will be audio recorded and a transcript will be prepared. Information obtained from the focus groups will be used to refine the patient and provider educational materials before we implement Aim 2 activities.

Aim 2: Conduct a pilot trial of BBN for patients with trauma histories in an IPC setting Baseline A primary care provider at one of the two approved Clinic locations will do a standard "warm handoff" referral to a behavioral health provider (BHP) if the patient is determined to have a behavioral health issue. This is one of the standard procedures used at the clinic. The BHP will ask the patient whether the patient is interested in participating the app study. If the patient indicates "yes", the BHP will complete the informed consent with the patient in a private room. Once the consent has been completed the BHP will screen the patient using the Adverse Childhood Experience screener to identify those individuals at risk for trauma related conditions. Any patients who screen positive on the ACE (>=3 points) will be invited to participate in further data collection for the study.

After the consent is completed, the BHP will complete the clinical assessment and treatment according to the standard of care specific to the mental health conditions the patient has including the evaluation listed under "Standard Clinical Assessment" section below. Then, the BHP will give a brief explanation of BBN (5 min) using the patient education material created under Aim 1 and suggest certain features of the app to be used (e.g., journal, sleep intervention) according to the need of the patient. Usage of the application is entirely self-paced, though usage of at least once per week is recommended for all app features. Still, users may elect to utilize the app at the pace of their choosing. The patient will be directed to areas of the app that are congruent with treatment focus identified during their standard of care appointment.

Also, the BHP will provide an instruction about the baseline data collection, which the patient will complete by going online or being contacted by a member of the research team member. The instruction will be also given in a paper format with the QR code for the online survey. The survey will include the items listed under "Research Assessment" below. The research assistant will contact all the patients in 2-3 days to help the patient navigate the BBN and complete the baseline survey if needed. If the patient prefers, the research assistant will administer the survey over the phone.

The patient will continue to meet with their BHP as determined by the standard of care interactions. And, if deemed appropriate the BHP will highlight features contained in BBN for patient to use in between appointments.

Follow-Up Phone Calls The follow-up phone calls will be scheduled for 2 week and 6 weeks after the initial visit. During these phone- calls the participant will be contacted by a member of the research team to complete follow-up surveys. Similar to the baseline data collection, the survey may be completed online or administered by the research assistant over the phone.

At the 6 week follow-up phone call, patient usability of the app will be assessed using the 18-item mHealth App Usability Questionnaire (MAUQ). Patient acceptability, will be measured using the 20-item User Burden Scale. Additionally semi-structured interviews will be completed at that time or scheduled for an alternate date.

The Use of BBN Usage of the app is entirely self-paced. While some features do have recommended intervals for use (e.g., weekly writing), users are able to schedule these at any interval they choose. The app will be introduced to the participant by the behavioral health provider using a shared decision-making framework where providers and participants collaborate to discuss how to best use the application. The app will only capture data pertaining to utilization, which will include initial login date, last use date, number of logins, and number of times each component is accessed.

Focus Group and Semi-Structured Interviews for Aim 2 Researchers will conduct 1 focus group with BHPs and individual video or semi-structures phone interviews with patients. They will ask questions to BHPs and patients about feasibility, acceptability, and usability of BBN and overall clinical protocol. The BHPs will complete a 5-item questionnaire about their comfort-level with integrating mental health apps into clinic care.

The semi-structured interviews with patients will be guided by the Integrated Promoting Action on Research Implementation in Health Services framework. The interviews will occur in a private location at the clinic or via Zoom, be audio recorded, and last no longer than 1 hour. Specifically, with the patient interviews, patients will be asked about the following: 1) the overall usability of of BBN, 2) the overall acceptability of BBN, 3) each major components of BBN, 4) the feasibility of incorporating BBN into the clinical practice, 5) the ease of using BBN to complete the surveys, and 6) strengths and weaknesses of BBN for treatment of their mental health condition. The focus group and interviews will be audio-recorded and transcribed.

Data Analysis Qualitative data will be tabulated and summarized using frequencies and percentages and will be analyzed using a direct content analysis approach. Focus group data will be transcribed and uploaded to QSR NVivo 12. As for qualitative data, a linear mixed effect model will be fitted to analyze each continuous outcome measured at different time points to estimate the potential intervention effect size for the future design of larger trials. A generalized linear mixed effect model with cumulative logistic link will be fitted to analyze ordinal outcome. Analysis will be performed using SAS.

Addressing Needs of African American and Low-Income Patients:

The participating clinics primarily serve African American or low income patients. Thus, almost all of the patients who will be recruited for Aims 1 and 2 are expected to come from these two population groups. Race/ethnicity and income information will be collected through E.H.R. data. The needs of these two patient population groups will be met by recruiting the patients primarily from these two population groups for Aim 1 to ensure that their perspectives will be reflected in the patient education materials. Similarly, the needs of these patients groups will be met by conducting a pilot for Aim 2 and obtaining feedback through the individual interviews we conduct at the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 22, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

-

Behavioral Health Providers:

• 19 years and older

Patients:

• 19 years and older

• Being newly referred to a behavioral health provider at the Fontanelle or Midtown Clinic

• Own a smart phone

• Score 3 points or higher on the Adverse Childhood Experience screening

Exclusion Criteria

Behavioral Health Providers:

• 18 years and younger

Patients:

• 18 years and younger

• Has been 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 E.H.R.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• BBN for Trauma Informed Care
Brief explanation of BBN will be provided. Patient will be directed to areas of the app that are congruent with treatment focus identified during their standard of care appointment. Patient will complete by going online or being contacted by a member of the research team member. The research assistant will contact all the patients in 2-3 days to help the patient navigate the BBN and complete the baseline survey if needed. The patient will continue to meet with their BHP as determined by the standard of care interactions. BHP will highlight features contained in BBN for patient to use in between appointments. Follow-up phone calls will be scheduled for 2 week and 6 weeks after the initial visit. During these phone- calls the participant will be contacted by a member of the research team to complete follow-up surveys.

Locations

Country	Name	City	State
United States	Nebraska Medical Center-Fontenelle Clinic	Omaha	Nebraska
United States	Nebraska Medical Center-Midtown Clinic	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (3)

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/s11606-012-2 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Aim 2: Feasibility	Feasibility will be assessed using semi-structured interviews. BHPs (n=4) and patients (n=15) will complete semi-structured interviews guided by the Integrated Promoting Action on Research Implementation in Health Services Framework.	8 months
Primary	Aim 2: Shared Decision Making	Perceptions of the shared decision-making process will be assessed during the semi-structured qualitative interviews guided by the shared-decision making model.	8 months
Primary	Aim 2: Acceptability: App use	Acceptability will also be measured by the number of patients who have downloaded and used the app.	8 months
Primary	Aim 2: Comfort Level	Providers will be asked to complete a 5-item questionnaire about their comfort-level with integrating mental health apps into clinic care. Measured on a 7 point Likert scale ranging from Strongly Disagree (1) to Strongly Agree (7)	8 months
Primary	Aim 2:Usability	Patient usability of the app will be assessed using the 18-item mHealth App Usability Questionnaire (MAUQ). In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app.	8 months
Primary	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 users two 5-point scales (ranging from 0 to 4). This allows the scale to have a higher score resulting in a higher level of user burden. Given that there are 20 total questions, the maximum score is 80 and the minimum score is 0.	8 months