Martha L. Bruce

A significant portion of mothers (pregnant and postpartum) enrolled in U.S. home visiting programs report clinically significant depressive symptoms. Non‐violent family conflict precipitates and exacerbates their depressive symptoms. This pilot randomized trial tested the preliminary effectiveness of a family therapy intervention, Resilience Enhancement Skills Training (REST), compared to the standard of care in home‐visited mothers with moderate to severe depressive symptoms and moderate to high conflict with family members. A total of 83 mothers and their family members (N = 166) were randomized to receive REST or the standard of care. Both interventions were delivered by clinicians using HIPAA‐compliant video conferencing technology. Outcomes were assessed by research assistants, blinded to study group assignment, at post‐intervention, 3, and 6 months later. Linear mixed‐effects models were used to analyze changes in continuous outcomes in mothers and family members, separately. Mixed‐effects logistic regression was used to analyze changes in maternal job attainment/school enrollment. Participants in both study groups showed improvements in outcomes. When compared to standard‐of‐care participants, REST participants had significantly greater reductions in family conflict (mothers ES = −1.19, family members ES = −0.77), maternal depressive symptoms (ES = −0.96) and co‐occurring anxiety symptoms (ES = −0.59), and greater increases in family cohesion (mothers ES = 0.99, family members ES = 0.94) and maternal job attainment/school enrollment (ES = 0.70). The results highlight the value of family therapy for the treatment of moderate to severe depressive symptoms in home‐visited mothers, including those with co‐occurring moderate to severe anxiety symptoms.Trial Registration: Registered in ClinicalTrials.gov on 02/04/2021. NCT04741776 https://clinicaltrials.gov/ct2/show/NCT04741776

Introduction: Operationalizing multi-site Community Engagement (CE) Studios to inform a research program is valuable for researchers. We describe the process and outcomes of hosting three CE Studios with Community Experts aged 65 years or older with chronic conditions and care partners of older adults. Experts gave feedback about processes for testing the feasibility, efficacy, effectiveness, and implementation of audio recording clinic visits and sharing recordings with patients who have multimorbidity and their care partners. Methods: The CE Cores of the Clinical and Translational Science Awards Programs at three academic health science centers created a joint CE Studio guide. Studios were conducted iteratively by site. Following receipt of the final reports, responses were compared to find themes, similarities, and differences on four topics in addition to overall commentary: Recruitment and Retention, Study Protocol, Study Reminders and Frequency, and Recording Technology. Results: Eighteen older adults and care partners in three states provided valuable feedback to inform multi-site trials. Feedback influenced multiple aspects of trials in process or subsequently funded. Experts provided critique on the wording of study invitations, information sheets, and reminders to engage in study procedures. Experts were concerned for participants being disappointed by randomization to a control arm and advised how investigators should prepare to address that. Conclusions: Multi-site CE Studios should be consecutive, so each team can learn from the previous teams. Using the CES Toolkit ensures that final reports were easily comparable and utilized to develop a research program that now includes three federally funded clinical trials.

Background: Although individual-level treatments exist for pregnant and postpartum women with depression, family conflict is a significant factor that can contribute to the development and severity of perinatal depressive symptoms. Yet, there is a lack of research on family therapy for perinatal women with moderate to severe depressive symptoms and family conflict. Further, research is needed on the feasibility, acceptability, safety, and tolerability of family therapies for perinatal depression that are delivered using Health Insurance Portability and Accountability Act–compliant videoconferencing technology (VCT). Objective: This paper describes the feasibility, acceptability, safety, and tolerability of a VCT-based family therapeutic intervention, Resilience Enhancement Skills Training (REST), for perinatal women with moderate to severe depressive symptoms and moderate to high conflict with their family members. Methods: This paper includes data from an ongoing randomized trial that compares an experimental family therapeutic intervention (REST) to standard of care (VCT-based problem-solving individual therapy) for the treatment of moderate to severe depressive symptoms in perinatal women with moderate to high family conflict. Both interventions were delivered by masters-level therapists using VCT. A total of 83 perinatal women and their adult family members (N=166 individuals) were recruited for participation in the study. Feasibility, defined as therapist adherence to ≥80% of REST session content, was assessed in audio-recorded sessions by 2 expert raters. Acceptability was defined as ≥80% of families completing REST, including completion of ≥80% homework assignments and family report of satisfaction with REST. Completion of REST was assessed by review of therapist session notes, and satisfaction was assessed by participant completion of a web-based questionnaire. The Beck Depression Inventory-Second Edition was administered to perinatal women by research assistants (blind to study group assignment) to assess safety, defined as a reduction in depressive symptoms during the treatment phase. The Family Environment Scale-Family Conflict subscale was administered by therapists to participants during the treatment phase to assess tolerability, defined as a reduction in family conflict during the treatment phase. Results: On average, the therapists achieved 90% adherence to REST session content. Of the families who started REST, 84% (32/38) of them completed REST, and on average, they completed 89% (8/9) of the homework assignments. Families reported satisfaction with REST. The results showed that REST is safe for perinatal women with moderate to severe depressive symptoms, and none discontinued due to worsened depressive symptoms. The results showed that REST is well tolerated by families, and no families discontinued due to sustained family conflict. Conclusions: The results show that REST is feasible, acceptable, safe, and tolerable for families. These findings will guide our interpretation of REST’s preliminary effectiveness upon completion of outcome data collection. Trial Registration: ClinicalTrials.gov NCT04741776; https://clinicaltrials.gov/ct2/show/NCT04741776

BACKGROUND Although individual-level treatments exist for pregnant and postpartum women with depression, family conflict is a significant factor that can contribute to the development and severity of perinatal depressive symptoms. Yet, there is a lack of research on family therapy for perinatal women with moderate to severe depressive symptoms and family conflict. Further, research is needed on the feasibility, acceptability, safety, and tolerability of family therapies for perinatal depression that are delivered using Health Insurance Portability and Accountability Act–compliant videoconferencing technology (VCT). OBJECTIVE This paper describes the feasibility, acceptability, safety, and tolerability of a VCT-based family therapeutic intervention, Resilience Enhancement Skills Training (REST), for perinatal women with moderate to severe depressive symptoms and moderate to high conflict with their family members. METHODS This paper includes data from an ongoing randomized trial that compares an experimental family therapeutic intervention (REST) to standard of care (VCT-based problem-solving individual therapy) for the treatment of moderate to severe depressive symptoms in perinatal women with moderate to high family conflict. Both interventions were delivered by masters-level therapists using VCT. A total of 83 perinatal women and their adult family members (N=166 individuals) were recruited for participation in the study. Feasibility, defined as therapist adherence to ≥80% of REST session content, was assessed in audio-recorded sessions by 2 expert raters. Acceptability was defined as ≥80% of families completing REST, including completion of ≥80% homework assignments and family report of satisfaction with REST. Completion of REST was assessed by review of therapist session notes, and satisfaction was assessed by participant completion of a web-based questionnaire. The Beck Depression Inventory-Second Edition was administered to perinatal women by research assistants (blind to study group assignment) to assess safety, defined as a reduction in depressive symptoms during the treatment phase. The Family Environment Scale-Family Conflict subscale was administered by therapists to participants during the treatment phase to assess tolerability, defined as a reduction in family conflict during the treatment phase. RESULTS On average, the therapists achieved 90% adherence to REST session content. Of the families who started REST, 84% (32/38) of them completed REST, and on average, they completed 89% (8/9) of the homework assignments. Families reported satisfaction with REST. The results showed that REST is safe for perinatal women with moderate to severe depressive symptoms, and none discontinued due to worsened depressive symptoms. The results showed that REST is well tolerated by families, and no families discontinued due to sustained family conflict. CONCLUSIONS The results show that REST is feasible, acceptable, safe, and tolerable for families. These findings will guide our interpretation of REST’s preliminary effectiveness upon completion of outcome data collection. CLINICALTRIAL ClinicalTrials.gov NCT04741776; https://clinicaltrials.gov/ct2/show/NCT04741776

Background: Providing digital recordings of clinic visits to patients has emerged as a strategy to promote patient and family engagement in care. With advances in natural language processing, an opportunity exists to maximize the value of visit recordings for patients by automatically tagging key visit information (eg, medications, tests, and imaging) and linkages to trustworthy web-based resources curated in an audio-based personal health library. Objective: This study aims to report on the user-centered development of HealthPAL, an audio personal health library. Methods: Our user-centered design and usability evaluation approach incorporated iterative rounds of video-recorded sessions from 2016 to 2019. We recruited participants from a range of community settings to represent older patient and caregiver perspectives. In the first round, we used paper prototypes and focused on feature envisionment. We moved to low-fidelity and high-fidelity versions of the HealthPAL in later rounds, which focused on functionality and use; all sessions included a debriefing interview. Participants listened to a deidentified, standardized primary care visit recording before completing a series of tasks (eg, finding where a medication was discussed in the recording). In the final round, we recorded the patients’ primary care clinic visits for use in the session. Findings from each round informed the agile software development process. Task completion and critical incidents were recorded in each round, and the System Usability Scale was completed by participants using the digital prototype in later rounds. Results: We completed 5 rounds of usability sessions with 40 participants, of whom 25 (63%) were women with a median age of 68 years (range 23-89). Feedback from sessions resulted in color-coding and highlighting of information tags, a more prominent play button, clearer structure to move between one’s own recordings and others’ recordings, the ability to filter recording content by the topic discussed and descriptions, 10-second forward and rewind controls, and a help link and search bar. Perceived usability increased over the rounds, with a median System Usability Scale of 78.2 (range 20-100) in the final round. Participants were overwhelmingly positive about the concept of accessing a curated audio recording of a clinic visit. Some participants reported concerns about privacy and the computer-based skills necessary to access recordings. Conclusions: To our knowledge, HealthPAL is the first patient-centered app designed to allow patients and their caregivers to access easy-to-navigate recordings of clinic visits, with key concepts tagged and hyperlinks to further information provided. The HealthPAL user interface has been rigorously co-designed with older adult patients and their caregivers and is now ready for further field testing. The successful development and use of HealthPAL may help improve the ability of patients to manage their own care, especially older adult patients who have to navigate complex treatment plans.

BACKGROUND Providing digital recordings of clinic visits to patients has emerged as a strategy to promote patient and family engagement in care. With advances in natural language processing, an opportunity exists to maximize the value of visit recordings for patients by automatically tagging key visit information (eg, medications, tests, and imaging) and linkages to trustworthy web-based resources curated in an audio-based personal health library. OBJECTIVE This study aims to report on the user-centered development of HealthPAL, an audio personal health library. METHODS Our user-centered design and usability evaluation approach incorporated iterative rounds of video-recorded sessions from 2016 to 2019. We recruited participants from a range of community settings to represent older patient and caregiver perspectives. In the first round, we used paper prototypes and focused on feature envisionment. We moved to low-fidelity and high-fidelity versions of the HealthPAL in later rounds, which focused on functionality and use; all sessions included a debriefing interview. Participants listened to a deidentified, standardized primary care visit recording before completing a series of tasks (eg, finding where a medication was discussed in the recording). In the final round, we recorded the patients’ primary care clinic visits for use in the session. Findings from each round informed the agile software development process. Task completion and critical incidents were recorded in each round, and the System Usability Scale was completed by participants using the digital prototype in later rounds. RESULTS We completed 5 rounds of usability sessions with 40 participants, of whom 25 (63%) were women with a median age of 68 years (range 23-89). Feedback from sessions resulted in color-coding and highlighting of information tags, a more prominent play button, clearer structure to move between one’s own recordings and others’ recordings, the ability to filter recording content by the topic discussed and descriptions, 10-second forward and rewind controls, and a help link and search bar. Perceived usability increased over the rounds, with a median System Usability Scale of 78.2 (range 20-100) in the final round. Participants were overwhelmingly positive about the concept of accessing a curated audio recording of a clinic visit. Some participants reported concerns about privacy and the computer-based skills necessary to access recordings. CONCLUSIONS To our knowledge, HealthPAL is the first patient-centered app designed to allow patients and their caregivers to access easy-to-navigate recordings of clinic visits, with key concepts tagged and hyperlinks to further information provided. The HealthPAL user interface has been rigorously co-designed with older adult patients and their caregivers and is now ready for further field testing. The successful development and use of HealthPAL may help improve the ability of patients to manage their own care, especially older adult patients who have to navigate complex treatment plans.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet