Clinical trial NCT05374408: Using Mobile Technology to Address the Trauma Mental Health Treatment Gap
Official title: IDeA-CTR-Using Mobile Technology to Address the Trauma Mental Health Treatment Gap in Primary Care: Developing Implementation Protocols for Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Traumatic Stress Disorder
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 29
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed description: BounceBack Now (BBN) is a Trauma Focused Mobile Application. After consent, a behavioral health provider (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 and 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 participants 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 integrated primary care (IPC) settings. Investigators 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 address acceptability, feasibility, and usability of the materials and the education materials and the app.

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 participants with trauma histories in an IPC setting. 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. The BHP will ask the patient about interest in participating the app study. If so, informed consent will be obtained and the participant screened using the Adverse Childhood Experience (ACE) screener to identify individuals at risk for trauma related conditions. Participants who screen positive on the ACE (\>=3 points) will be invited to participate in further data collection for the study. A clinical assessment will be conducted, and a treatment assigned according to the standard of care specific to the mental health conditions of the participant. A brief explanation of BBN will be provided using the patient education material created under Aim 1. Certain features of the app will be suggested for use (e.g., journal, sleep intervention) according to participant need. The application is entirely self-paced, but a minimum use at least once a week is recommended.

Participants will complete a baseline survey online or through an investigational team member. Participants 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 participant to use in between appointments. Follow-up phone calls will be scheduled for 2 week and 6 weeks after the initial visit to complete follow-up surveys, either online or administered by the investigative assistant over the phone. At the 6-week follow-up phone call, usability of the app will be assessed using the 18-item mHealth App Usability Questionnaire (MAUQ). 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 BHPs will complete a 5-item questionnaire about their comfort-level with integrating mental health apps into clinic care.

Addressing Needs of African American and Low-Income Patients:

The participating clinics primarily serve African American or low income patients. Race/ethnicity and income information will be collected through electronic health record data. The needs of these two patient population groups will be met by recruiting participants primarily from these two population groups for both aims to ensure their perspectives will be reflected in the patient education materials and by obtaining feedback through the individual interviews conducted at the end of the study.

Eligibility criteria: Inclusion Criteria:

Behavioral Health Providers:

• 19 years and older

Participants:

* 19 years and older
* Newly referred to a behavioral health provider at the Fontanelle or Midtown Clinic
* Own a smart phone

Exclusion Criteria

Behavioral Health Providers:

• 18 years and younger

Participants:

* 18 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)

Primary outcomes:
measure: Aim 1: Evaluation of Educational Materials
timeFrame: 5 months
measure: Aim 2: Feasibility
timeFrame: 8 months
measure: Aim 2: Shared Decision Making
timeFrame: 8 months
measure: Aim 2: Acceptability: App use
timeFrame: 8 months
measure: Aim 2: Comfort Level
timeFrame: 8 months
measure: Aim 2:Usability
timeFrame: 8 months
measure: Aim 2: Patient Burden
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Medical Center-Fontenelle Clinic
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Medical Center-Midtown Clinic
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Margaret R Emerson, DNP, APRN
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.