Phone Sessions Research Articles

Telephone lifestyle intervention to prevent diabetes in women with recent gestational diabetes mellitus attending the national health system: the LINDA-Brasil clinical trial

ObjectivesTo evaluate a postpartum telephone-based lifestyle intervention to prevent diabetes in high-risk women with recent gestational diabetes mellitus (GDM).DesignMulticentre parallel randomised clinical trial.SettingSpecialised antenatal clinics in the Brazilian National System.MethodsLifestyle...

The Association Between COVID-fear with Psychological Distress and Substance Use: the Moderating Effect of Treatment Engagement.

The purpose of this brief report was to examine the association between COVID-fear with psychiatric symptoms severity and substance use risk in an outpatient population with co-occurring substance use and mental health disorders and whether these associations were moderated by treatment engagement, especially after providers had shifted from an in-person care model to a telehealth format. A total of 136 patients receiving outpatient treatment for comorbid substance use and mental health disorders completed self-report questionnaires on their psychiatric symptoms, substance use, and treatment engagement (i.e., frequency, length, and helpfulness of phone and video sessions with a mental health counselor, psychiatrist, or primary care provider) in the past month between November 2020 and March 2021. Results showed that COVID-fear was significantly associated with psychiatric symptom severity, but not substance use risk. Additionally, perceived helpfulness of phone counseling sessions moderated the associations between COVID-fear and global psychiatric symptom severity, such that COVID-fear and global psychiatric symptom severity were positively associated when perceived helpfulness was low, and not associated if perceived helpfulness was high. The present results highlight the importance of directly addressing fears specific to a national emergency, as well as for providers to build strong rapport with their clients.

A Brief Alcohol Intervention (BAI) to reduce alcohol use and improve PrEP outcomes among men who have sex with men in Vietnam: study protocol for a randomized controlled trial

BackgroundIn Vietnam and other global settings, men who have sex with men (MSM) have become the population at greatest risk of HIV infection. Although HIV pre-exposure prophylaxis (PrEP) has been implemented as a prevention strategy, PrEP outcomes may be affected by low persistence and adherence among MSM with unhealthy alcohol use. MSM have a high prevalence of unhealthy alcohol use in Vietnam, which may affect PrEP outcomes.MethodsDesign: We will conduct a two-arm hybrid type 1 effectiveness-implementation randomized controlled trial of a brief alcohol intervention (BAI) compared to the standard of care (SOC) at the Sexual Health Promotion (SHP) clinic Hanoi, Vietnam.Participants: Sexually active MSM (n=564) who are newly initiating PrEP or re-initiating PrEP and have unhealthy alcohol use will be recruited and randomized 1:1 to the SOC or BAI arm. A subgroup of participants (n=20) in each arm will be selected for longitudinal qualitative interviews; an additional subset (n=48) in the BAI arm will complete brief quantitative and qualitative interviews after completion of the BAI to assess the acceptability of the intervention. Additional implementation outcomes will be assessed through interviews with clinic staff and stakeholders (n=35).Intervention: Study participants in both arms will receive standard care for PrEP clients. In the BAI arm, each participant will receive two face-to-face intervention sessions and two brief booster phone sessions, based on cognitive behavioral therapy and delivered in motivational interviewing informed style, to address their unhealthy alcohol use.Outcomes: Effectiveness (PrEP and alcohol use) and cost-effectiveness outcomes will be compared between the two arms. Intervention implementation outcomes (acceptability, feasibility, adoption) will be assessed among MSM participants, clinic staff, and stakeholders.DiscussionThis proposed trial will assess an alcohol intervention for MSM with unhealthy alcohol use who initiate or re-initiate PrEP, while simultaneously preparing for subsequent implementation. The study will measure the effectiveness of the BAI for increasing PrEP persistence through reducing unhealthy alcohol use in a setting where excessive alcohol consumption is a normative behavior. If effective, implementation-focused results will inform future scale-up of the BAI in similar settings.Trial registrationNCT06094634 on clinicaltrials.gov. Registered 16 October 2023.

A Positive Psychology Intervention in Allogeneic Hematopoietic Stem Cell Transplantation Survivors (PATH): A Pilot Randomized Clinical Trial.

Allogeneic hematopoietic stem cell transplantation (HSCT) survivors experience significant psychological distress and low levels of positive psychological well-being, which can undermine patient-reported outcomes (PROs), such as quality of life (QoL). Hence, we conducted a pilot randomized clinical trial to assess the feasibility and preliminary efficacy of a telephone-delivered positive psychology intervention (Positive Affect for the Transplantation of Hematopoietic stem cells intervention [PATH]) for improving well-being in HSCT survivors. HSCT survivors who were 100 days post-HSCT for hematologic malignancy at an academic institution were randomly assigned to either PATH or usual care. PATH, delivered by a behavioral health expert, entailed 9 weekly phone sessions on gratitude, personal strengths, and meaning. We defined feasibility a priori as >60% of eligible participants enrolling in the study and >75% of PATH participants completing ≥6 of 9 sessions. At baseline and 9 and 18 weeks, patients self-reported gratitude, positive affect, life satisfaction, optimism, anxiety, depression, posttraumatic stress disorder (PTSD), QoL, physical function, and fatigue. We used repeated measures regression models and estimates of effect size (Cohen's d) to explore the preliminary effects of PATH on outcomes. We enrolled 68.6% (72/105) of eligible patients (mean age, 57 years; 50% female). Of those randomized to PATH, 91% completed all sessions and reported positive psychology exercises as easy to complete and subjectively useful. Compared with usual care, PATH participants reported greater improvements in gratitude (β = 1.38; d = 0.32), anxiety (β = -1.43; d = -0.40), and physical function (β = 2.15; d = 0.23) at 9 weeks and gratitude (β = 0.97; d = 0.22), positive affect (β = 2.02; d = 0.27), life satisfaction (β = 1.82; d = 0.24), optimism (β = 2.70; d = 0.49), anxiety (β = -1.62; d = -0.46), depression (β = -1.04; d = -0.33), PTSD (β = -2.50; d = -0.29), QoL (β = 7.70; d = 0.41), physical function (β = 5.21; d = 0.56), and fatigue (β = -2.54; d = -0.33) at 18 weeks. PATH is feasible, with promising signals for improving psychological well-being, QoL, physical function, and fatigue in HSCT survivors. Future multisite trials that investigate PATH's efficacy are needed to establish its effects on PROs in this population.

Peer navigation: a pilot study to improve recovery capital for alcohol and other drug telephone helpline callers

Background People with alcohol and other drug (AOD) use problems face multiple barriers to care. Peer navigation may overcome known barriers to care. This pilot study explored the impact of peer navigation integrated into an AOD telephone helpline. Methods Helpline callers (n = 34; 21 male, 12 female, 1 non-binary; mean age 41.3 years) were connected to a peer worker for 6 weekly phone sessions. Linear mixed models were performed to assess change in recovery capital, self-efficacy, and substance use post-intervention and 3-months follow-up. A descriptive approach was used to analyse qualitative data. Results Participants attended a mean of 4.2 sessions (range 0 to 8). Analyses showed significant improvements in recovery capital (B = 2.56, p <.001) and self-efficacy (B = 0.18, p =.015) at exit and follow-up respectively. Participants showed significant reductions in substance use at follow-up. Qualitative analysis indicated participants described unique benefits related to working with a peer, including help to access resources and support. Conclusion Peer navigation via an AOD helpline has potential to support callers to improve recovery-related outcomes. More research is needed to assess the efficacy of peer programs in helping overcome barriers to accessing care.

The Effects of Nurse-Led Supportive Care Program on Quality of Life in Women with Breast Cancer Receiving Adjuvant Chemotherapy: A Randomized Controlled Pilot Study

This study was to evaluate the effects of nurse-led supportive care program on quality of life in women with breast cancer receiving adjuvant chemotherapy. The study was carried out a parallel group randomized controlled pilot study with repeated-measures design in general surgery unit of a training and research hospital. Forty-two women with newly diagnosed breast cancer were randomly assigned to the intervention and control groups. The intervention group received nurse-led supportive care program for 8 weeks, 4 weeks in face-to-face sessions and 4 weeks through phone sessions. The control group received only routine treatment. The women in both groups completed the EORTC-QLQ-C30 (version 3.0) Quality of Life questionnaires at baseline and ninth week. There was a significant increase in the mean global health status and functional status scores of the women with breast cancer in the intervention group compared to the women in the control group in the ninth week compared to the baseline. The women in the intervention group had a lower mean symptom status score in the ninth week than the women in the control group and there was a statistically significant difference in the change in the mean scores of the groups over time. Our nurse-led supportive care program is an effective, safe and acceptable method to support women with BC receiving adjuvant chemotherapy. The nurse-led supportive care program can be used as a reliable and effective nursing intervention to increase the quality of life of women breast cancer receiving adjuvant chemotherapy. NCT05399160.

The Eschucha (Listen) Podcast Project: Psychosocial Innovation for Marginalized Mexican Youth and Young Adults.

The COVID-19 pandemic was a challenging period for young people in Mexico, particularly those already contending with social and structural inequality. In March 2021, the Colectivo Frontera, a research collective based in Mexico City, Mexico, which works on advancing equity and psychosocial wellbeing among marginalized communities, carried out an 8-week, online project to provide psychosocial support and promote resilience for marginalized young people from different locations in Mexico. The project entailed weekly journaling with the Pandemic Journaling Project (PJP), as well as weekly phone sessions with a mental health specialist who provided emotional support (acompañamiento emocional) through practices of active listening. The project culminated in the Escucha (Listen) Podcast for which each youth participant created an episode about their experiences during the pandemic. Many also submitted a photo to accompany their recording; one produced a song. Participant episodes were compiled into a series of five chapters. Each chapter of the podcast centers on a common theme, including reflections on loved ones lost to COVID-19, social fragmentation, gender-based constraints on expressing emotions, and the experiences and perspectives of children. The project provides a compelling example of a low-cost approach to providing support for the mental health and wellbeing of marginalized young people. It also demonstrates the importance of creating projects that help young people make meaningful connections and that leverage their creativity to foster resilience, improve social cohesion, and elevate their perspectives and voices.

Exploring preference for delivery methods for a psychosocial intervention for prenatal anxiety: A qualitative study from a tertiary care hospital in Pakistan.

This qualitative study explores therapists' and participants' preferences for delivery methods (face-to-face and phone sessions) of a cognitive behavioral therapy-based psychosocial intervention for prenatal anxiety delivered in a tertiary care hospital. The research was conducted in a randomized controlled trial in Pakistan, where a shift from face-to-face to phone-based therapy occurred during the coronavirus disease-2019 (COVID-19) pandemic. Twenty in-depth interviews and a focus group discussion were conducted with participants and therapists, respectively. Transcripts were analyzed using thematic analysis. Participants generally preferred face-to-face sessions for rapport building, communication, and comprehension. However, barriers like venue accessibility, childcare, and lack of family support hindered engagement. Telephone sessions were favored for easy scheduling and the comfort of receiving the session at home, but there were challenges associated with phone use, distractions at home, and family members' limited mental health awareness. A mix of face-to-face and telephone sessions was preferred, with rapport from in-person sessions carrying over to telephone interactions. This study underscores the need for adaptable intervention delivery strategies that consider cultural norms, logistical challenges, and individual family dynamics. By combining the benefits of both delivery methods, mental health interventions can be optimized to effectively address prenatal anxiety and promote well-being in resource-constrained settings like Pakistan.

Therapist-Reported Differences between Teletherapy via Phone and via Videoconferencing.

When therapists provide teletherapy they can choose between teletherapy via phone and teletherapy via videoconferencing, however, little is known about differences between using these two teletherapy formats. We aimed to compare therapists' attitudes, level of professional self-doubt, and experience of the therapeutic relationship in sessions conducted via phone versus via videoconferencing. We administered an online survey to 117 therapists who had experience with sessions both via phone and videoconferencing. The results suggested that therapists' attitudes and perceptions of the therapeutic relationship were similar. However, therapists' level of professional self-doubt was higher in sessions conducted via videoconferencing. Therapists with previous experience of conducting teletherapy via phone perceived phone sessions more positively. Thus, familiarity with videoconferencing technology might be more important in shaping therapists' attitudes and confidence than the type of technology per se. This highlights the importance of practicing with new technologies.

A Positive Psychology Intervention in Allogeneic Hematopoietic Stem Cell Transplantation Survivors (PATH) to Promote Well-Being: Randomized Controlled Feasibility and Preliminary Efficacy Trial

Background: Patients with hematologic malignancies who are allogeneic hematopoietic stem cell transplantation (HSCT) survivors experience tremendous psychological symptoms (e.g., anxiety and depression symptoms) and low levels of positive psychological well-being (e.g., flourishing, gratitude), which further undermine multiple health-related outcomes such as quality of life (QOL). However, supportive oncology interventions which specifically target positive psychological well-being may buffer against psychological distress and promote QOL. Thus, we developed and piloted a novel phone-delivered positive psychology intervention (PATH) to improve QOL and symptoms of anxiety and depression in HSCT survivors transplanted for hematologic malignancies. Methods: We conducted a randomized controlled trial (NCT05147311) to assess feasibility, acceptability, and preliminary efficacy of the PATH intervention. From August 2021 to August 2022, 70 HSCT survivors who were 100-days post-HSCT were randomly assigned to either PATH or a usual care control group. The PATH group had 9 weekly 1:1 phone sessions of positive psychology exercises focused on gratitude, strengths, and meaning. The Usual care group had routine sessions with the transplant social worker. We defined feasibility as &amp;gt;60% of eligible participants enrolling in the study and &amp;gt;75% of intervention group participants completing at least 6 of the 9 positive psychology sessions. At baseline and 9 and 18 weeks after baseline, patients self-reported optimism (Life Orientation Test Revised), gratitude, (Gratitude Questionnaire-6), flourishing (Flourishing Scale), QOL (Functional Assessment of Cancer Therapy-Bone Marrow Transplant) and depression and anxiety (Hospital Anxiety and Depression Scale). We used mixed effects regression analyses to determine the potential impact of PATH on QOL and symptoms of anxiety and depression. Results: The average age (standard deviation) of participants was 56.8 (13.7) years; 50% (N=35) were female. The majority of the participants identified as White (91.4%; N=64), married or living with a partner (71.4%; N=50), had at least a college education (67.2%; N=47) and were on disability or retired (87.1%; N=67). The majority had a diagnosis of leukemia (68.6%; N=48), underwent reduced intensity conditioning (62.9%; N=44), and did not have acute graft-versus-host disease (68.6%; N=48). For our feasibility metrics, we enrolled 68.6% (72/105) of eligible patients, two of which were not randomized due to worsening physical symptoms. Additionally, 94% (95% CI: 79%-99%) of those who started the PATH intervention completed all nine intervention sessions. For acceptability, participants in the intervention group reported positive psychology exercises as easy to complete (mean [95% CI] = 7.40 [6.87, 7.92] on a scale of 0-10) and useful (mean [95% CI] = 8.23 [7.83, 8.63]). Compared with usual care, participants in the intervention group reported less symptoms of anxiety ( d=0.46, p=0.027), and demonstrated promising improvements in gratitude ( d=0.26) at 9 weeks. We did not observe significant differences in QOL and depression symptoms. Conclusions: A positive psychology intervention, PATH, is feasible, acceptable, and has potential to improve outcomes in patients with hematologic malignancies who are allogeneic HSCT survivors. Larger trials are needed to examine the impact of PATH on psychological well-being and QOL in this population.

Peer-supported mobile mental health for veterans in primary care: A pilot study.

One in four veteran primary care patients suffers from a mental health condition; however, most do not receive any treatment for these problems. Mobile health (mHealth) can overcome barriers to care access, but poor patient engagement limits the effectiveness and implementation of these tools. Peers may facilitate patient engagement with mHealth. We designed a protocol for peers to support implementation of mobile mental health tools in primary care and tested the feasibility, acceptability, and clinical utility of this approach. Thirty-nine patients across two Veterans Affairs sites who screened positive for depression during a primary care visit and were not currently in mental health treatment were enrolled. Participants were scheduled for four phone sessions with a peer over 8 weeks and introduced to five mobile apps for a range of transdiagnostic mental health issues (stress, low mood, sleep problems, anger, and trauma). Pre/post phone interviews using quantitative and qualitative approaches assessed participants' self-reported app use, satisfaction with the intervention, symptom change (stress, anxiety, depression, insomnia), and progress with personal health goals. On average, patients reported using 3.04 apps (SD = 1.46). Per the Client Satisfaction Questionnaire, global satisfaction with the intervention was high (M = 25.71 out of 32, SD = 3.95). Pre to post participants reported significant improvements in their level of stress, based on a quantitative measure (p = .008), and 87% reported progress on at least one personal health goal. Findings support the feasibility, acceptability, and clinical utility of peer-supported mobile mental health for veterans in primary care. A randomized controlled trial of an adaptive version of this intervention is recommended. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Stand Down–Think Before You Drink: protocol for an effectiveness-implementation trial of a mobile application for unhealthy alcohol use with and without peer support

IntroductionMobile apps can increase access to alcohol-related care but only if patients actively engage with them. Peers have shown promise for facilitating patients’ engagement with mobile apps. However, the effectiveness...

Feasibility and Acceptability of the Promoting Resilience in Stress Management-Parent (PRISM-P) Intervention for Caregivers of Children with Craniofacial Conditions.

Few evidence-based psychosocial programs exist within craniofacial care. This study (a) assessed feasibility and acceptability of the Promoting Resilience in Stress Management-Parent (PRISM-P) intervention among caregivers of children with craniofacial conditions and (b) described barriers and facilitators of caregiver resilience to inform program adaptation. In this single-arm cohort study, participants completed a baseline demographic questionnaire, the PRISM-P program, and an exit interview. Eligible individuals were English-speaking legal guardians of a child <12-years-old with a craniofacial condition. PRISM-P included 4 modules (stress-management, goal-setting, cognitive-restructuring, meaning-making) delivered in 2 one-on-one phone or videoconference sessions 1-2 weeks apart. Feasibility was defined as >70% program completion among enrolled participants; acceptability was defined as >70% willingness to recommend PRISM-P. Intervention feedback and caregiver-perceived barriers and facilitators of resilience were summarized qualitatively. Twenty caregivers were approached and 12 (60%) enrolled. The majority were mothers (67%) of a child <1-year-old diagnosed with a cleft lip and/or palate (83%) or craniofacial microsomia (17%). Of these, 8 (67%) completed PRISM-P and 7 (58%) completed interviews; 4 (33%) were lost-to-follow-up before PRISM-P and 1 (8%) before the interview. Feedback was highly positive, with 100% willing to recommend PRISM-P. Perceived barriers to resilience included uncertainty about their child's health; facilitators included social support, parental identity, knowledge, and control. PRISM-P was acceptable among caregivers of children with craniofacial conditions but not feasible based on program completion rates. Barriers and facilitators of resilience support the appropriateness of PRISM-P for this population and inform adaptation.

Integrated collaborative care intervention for depression and obesity in primary care: translation from research to practice.

The objective of this study was to present lessons learned about engagement, delivery modality and pandemic impact while delivering a collaborative care intervention with a socioeconomically, racially and ethnically diverse sample. Participants completed a post-intervention survey (n = 41) on experiences and preferred intervention delivery modality, coronavirus 2019 (COVID-19) Impact Survey (n = 50) and provided open-ended feedback about the intervention (n = 27). Intervention process data included attendance, modality, and withdrawals. Data were analyzed using descriptive statistics and inductive content analyses. Of 71 intervention participants, 6 (8%) withdrew before session 1. Completers adhered to intervention timeline better than withdrawals. Participants liked the in-person interaction, efficient coach support, accountability of in-person and Zoom vs. phone sessions and the flexibility and convenience of phone and Zoom vs. in-person sessions. A majority of participants reported experiencing pandemic impacts such as heightened emotional distress, decreased activity engagement, poorer eating behaviors and being unable to meet basic needs. Participants deviating from intervention timelines may be re-engaged by targeted outreach attempts. Videoconference has the potential for providing as-needed coaching. Future interventions may be optimized to account for and address areas impacted by the pandemic. Findings revealed specific strategies that can be implemented in future interventions to improve emotional and physical health among diverse populations.

Adapting Community Educational Programs During the COVID-19 Pandemic: Comparing the Feasibility and Efficacy of a Lung Cancer Screening Educational Intervention by Mode of Delivery.

Few eligible patients receive lung cancer screening. We developed the Lung AIR (awareness, information, and resources) intervention to increase community education regarding lung cancer screening. The intervention was designed as an in-person group intervention; however, the COVID-19 pandemic necessitated adapting the mode of delivery. In this study we examined intervention feasibility and efficacy overall and by mode of delivery (in-person group vs. one-on-one phone) to understand the impact of adapting community outreach and engagement strategies. Feasibility was examined through participant demographics. Efficacy was measured through pre/post knowledge, attitudes, and beliefs about lung cancer screening, and intention to complete screening. We reached N = 292 participants. Forty percent had a household income below $35,000, 58% had a high school degree or less, 40% were Hispanic, 57% were Black, and 84% reported current or past smoking. One-on-one phone sessions reached participants who were older, had lower incomes, more current smoking, smoked for more years, more cigarettes per day, lower pre-intervention lung cancer screening knowledge, and higher pre-intervention fear and worry. Overall pre/post test scores show significant increases in knowledge, salience, and coherence, and reduced fear and worry. Participants in the one-on-one phone sessions had significantly higher increases in salience and coherence and intention to complete screening compared to participants in the in-person group sessions. The Lung AIR intervention is a feasible and effective community-based educational intervention for lung cancer screening. Findings point to differences in reach and efficacy of the community-based intervention by mode of delivery.

A Randomized Trial of Telephone-Based Smoking Cessation Treatment in the Lung Cancer Screening Setting.

Lung cancer mortality is reduced via low-dose computed tomography screening and treatment of early-stage disease. Evidence-based smoking cessation treatment in the lung screening setting can further reduce mortality. We report the results of a cessation trial from the National Cancer Institute's Smoking Cessation at Lung Examination collaboration. Eligible patients (n = 818) aged 50-80 years were randomly assigned (May 2017-January 2021) to the intensive vs minimal arms (8 vs 3 phone sessions plus 8 vs 2 weeks of nicotine patches, respectively). Bio-verified (primary) and self-reported 7-day abstinence rates were assessed at 3, 6, and 12 months post random assignment. Logistic regression analyses evaluated the effects of study arm. All statistical tests were 2-sided. Participants reported 48.0 (SD = 17.2) pack-years, and 51.6% were not ready to quit in less than 30 days. Self-reported 3-month quit rates were statistically significantly higher in the intensive vs minimal arm (14.3% vs 7.9%; odds ratio [OR] = 2.00, 95% confidence interval [CI] = 1.26 to 3.18). Bio-verified abstinence was lower but with similar relative differences between arms (9.1% vs 3.9%; OR = 2.70, 95% CI = 1.44 to 5.08). Compared with the minimal arm, the intensive arm was more effective among those with greater nicotine dependence (OR = 3.47, 95% CI = 1.55 to 7.76), normal screening results (OR = 2.58, 95% CI = 1.32 to 5.03), high engagement in counseling (OR = 3.03, 95% CI = 1.50 to 6.14), and patch use (OR = 2.81, 95% CI = 1.39 to 5.68). Abstinence rates did not differ statistically significantly between arms at 6 months (OR = 1.2, 95% CI = 0.68 to 2.11) or 12 months (OR = 1.4, 95% CI = 0.82 to 2.42). Delivering intensive telephone counseling and nicotine replacement with lung screening is an effective strategy to increase short-term smoking cessation. Methods to maintain short-term effects are needed. Even with modest quit rates, integrating cessation treatment into lung screening programs may have a large impact on tobacco-related mortality.

A phone and text message intervention to improve physical activity in midlife: initial feasibility testing

ABSTRACT Background Physical activity during midlife (ages 45-64) plays a major role in the prevention of chronic and serious medical conditions. Unfortunately, many midlife adults struggle to be physically active in the setting of low levels of psychological well-being and the management of multiple confluent sources of stress. Effective, scalable, midlife-specific interventions are needed to promote physical activity and prevent the development of chronic medical conditions. Objectives In an initial proof-of-concept trial, we assessed the feasibility and acceptability of a new, midlife-adapted, phone- and text message-based intervention using positive psychology (PP) skill-building and motivational interviewing (MI) techniques. We secondarily analyzed post-intervention changes in accelerometer-measured physical activity and self-reported outcomes. Methods The PP-MI intervention included six weekly phone sessions with a study trainer, with completion of PP activities and physical activity goals between calls, and in the subsequent six weeks briefer phone check-ins were conducted. Text messages over the 12-week intervention period were utilized to support participants and identify barriers to goal completion. Feasibility (session completion rates) and acceptability (participant ratings of intervention ease and utility) were assessed via descriptive statistics, and pre-post improvements in psychological, functional, and physical activity outcomes at 12 weeks were examined via mixed effects regression models. Results Twelve midlife adults with low baseline physical activity enrolled in the single-arm trial. Overall, 76.8% of all possible sessions were completed by participants, and mean ratings of weekly phone sessions were 8.9/10 (SD 1.6), exceeding our a priori thresholds for feasibility and acceptability. Participants demonstrated generally medium to large effect size magnitude improvements in accelerometer-measured physical activity, psychological outcomes, and function. Conclusions A novel, midlife-specific phone- and text-based PP-MI intervention was feasible and had promising effects on physical activity and other clinically relevant outcomes, supporting next-step testing of this program via a randomized controlled trial.

A lay navigator-led, early palliative care intervention for African American and rural family caregivers of individuals with advanced cancer (Project Cornerstone): Results of a pilot randomized trial.

The objective of this study was to assess the feasibility, acceptability, and potential efficacy of ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone-a lay navigator-led, early palliative care telehealth intervention for African American/Black and/or rural-dwelling family caregivers of individuals with advanced cancer (ClinicalTrials.gov identifier NCT03464188). This was a pilot randomized trial (November 2019 to March 2021). Family caregivers of patients with newly diagnosed, stage III/IV, solid-tumor cancers were randomized to receive either an intervention or usual care. Intervention caregivers were paired with a specially trained lay navigator who delivered 6 weekly, 20-minute to 60-minute telehealth coaching sessions plus monthly follow-up for 24 weeks, reviewing skills in stress management, self-care, getting help, staying organized, and future planning. Feasibility was assessed according to the completion of sessions and questionnaires (predefined as a completion rate ≥80%). Acceptability was determined through intervention participants' ratings of their likelihood of recommending the intervention. Measures of caregiver distress and quality of life were collected at 8 and 24 weeks. Sixty-three family caregivers were randomized (usual care, n = 32; intervention, n = 31). Caregivers completed 65% of intervention sessions and 87% of questionnaires. Average ratings for recommending the program were 9.4, from 1 (not at all likely) to 10 (extremely likely). Over 24 weeks, the mean ± SE Hospital Anxiety and Depression Scale score improved by 0.30 ± 1.44 points in the intervention group and worsened by 1.99 ± 1.39 points in the usual care group (difference, -2.29; Cohen d, -0.32). The mean between-group difference scores in caregiver quality of life was -1.56 (usual care - intervention; d, -0.07). Similar outcome results were observed for patient participants. The authors piloted ENABLE Cornerstone, an intervention for African American and rural-dwelling advanced cancer family caregivers. The acceptability of the intervention and data collection rates were high, and the preliminary efficacy for caregiver distress was promising. To date, very few programs have been developed to support under-resourced cancer family caregivers. To address this need, the authors successfully pilot tested an early palliative care program, called Educate, Nurture, Advise, Before Life Ends (ENABLE) Cornerstone, for African American and rural family caregivers of individuals with advanced cancer. Cornerstone is led by specially trained lay people and involves a series of weekly phone sessions focused on coaching caregivers to manage stress and provide effective support to patients with cancer. The authors are now testing Cornerstone in a larger trial. If the program demonstrates benefit, it may yield a model of caregiver support that could be widely implemented.

MI-PACE Home-Based Cardiac Telerehabilitation Program for Heart Attack Survivors: Usability Study.

BackgroundCardiac rehabilitation programs, consisting of exercise training and disease management interventions, reduce morbidity and mortality after acute myocardial infarction.ObjectiveIn this pilot study, we aimed to developed and assess the feasibility of delivering a health watch–informed 12-week cardiac telerehabilitation program to acute myocardial infarction survivors who declined to participate in center-based cardiac rehabilitation.MethodsWe enrolled patients hospitalized after acute myocardial infarction at an academic medical center who were eligible for but declined to participate in center-based cardiac rehabilitation. Each participant underwent a baseline exercise stress test. Participants received a health watch, which monitored heart rate and physical activity, and a tablet computer with an app that displayed progress toward accomplishing weekly walking and exercise goals. Results were transmitted to a cardiac rehabilitation nurse via a secure connection. For 12 weeks, participants exercised at home and also participated in weekly phone counseling sessions with the nurse, who provided personalized cardiac rehabilitation solutions and standard cardiac rehabilitation education. We assessed usability of the system, adherence to weekly exercise and walking goals, counseling session attendance, and disease-specific quality of life.ResultsOf 18 participants (age: mean 59 years, SD 7) who completed the 12-week telerehabilitation program, 6 (33%) were women, and 6 (33%) had ST-elevation myocardial infarction. Participants wore the health watch for a median of 12.7 hours (IQR 11.1, 13.8) per day and completed a median of 86% of exercise goals. Participants, on average, walked 121 minutes per week (SD 175) and spent 189 minutes per week (SD 210) in their target exercise heart rate zone. Overall, participants found the system to be highly usable (System Usability Scale score: median 83, IQR 65, 100).ConclusionsThis pilot study established the feasibility of delivering cardiac telerehabilitation at home to acute myocardial infarction survivors via a health watch–based program and telephone counseling sessions. Usability and adherence to health watch use, exercise recommendations, and counseling sessions were high. Further studies are warranted to compare patient outcomes and health care resource utilization between center-based rehabilitation and telerehabilitation.

Abstract P191: Telephone-based Mindfulness Training In Diverse Prehypertensive Women: Results Of A Pilot Randomized Controlled Trial

Introduction: Chronic stress is associated with incident hypertension and is a promising intervention target for lowering blood pressure (BP), particularly in women. Growing evidence suggests that mindfulness-based interventions can reduce BP and improve psychological outcomes but the in-person format of traditional programs limits access. The goal of this study was to evaluate the feasibility, acceptability and effects of telephone-delivered mindfulness-based cognitive therapy (MBCT-T) in women with prehypertension. Methods: We conducted a pilot RCT in which 37 women meeting JNC 7 criteria for prehypertension (SBP 120-139 mmHg or DBP 80-89 mmHg) and not taking antihypertensive medication were recruited from outpatient clinics or via the EHR. Eligible participants were randomized to usual care or MBCT-T, which involved 8 weekly 1-hour phone sessions delivered to small groups by a trained instructor. Outcomes included feasibility (session completion), acceptability (Client Satisfaction Questionnaire [CSQ]), SBP (mean of 3 clinic BP measurements), perceived stress (PSS-10) and depressive symptoms (PHQ-8). Linear mixed models with a random effect of intervention cohort were performed to compare 3-month changes in outcomes between study arms, adjusting for age and ethnicity. Results: The mean age was 50.7±17.7, 68% of participants were racial/ethnic minorities, and baseline SBP/DBP was 127.8±6.2/77.5±7.2 mmHg. There were no significant differences between study arms in demographics or baseline characteristics. The median number of sessions completed was 6 of 8. Fewer sessions were completed by employed vs. unemployed women (4.5 vs. 7.8, t=3.55, p=.003) and by foreign-born vs. U.S.-born women (2.8 vs. 5.9, t=1.87, p=.08). Overall 3-month retention was 89% but follow-up BP was missing in ~50% of participants due to COVID-19 research restrictions. Three-quarters of MBCT-T participants reported high satisfaction with the intervention (CSQ24). In the subgroup with complete follow-up data, SBP declined in both study arms but there was no significant between-group difference (p=0.51). Conversely, greater reductions in perceived stress and depressive symptoms were observed in the MBCT-T arm vs. usual care (between-group differences of 3.63 [PSS-10; p=.163] and 2.90 [PHQ-8; p=.008]). In per-protocol analyses limited to MBCT-T participants who completed ≥4 sessions, effects were larger for perceived stress and similar for depressive symptoms (between-group differences of 6.17 [PSS-10; p=.012] and 2.77 [PHQ-8; p=.025]). Conclusions: Results support the feasibility and acceptability of telephone-based mindfulness training in diverse women with prehypertension. Promising findings for stress and depressive symptoms suggest further studies are warranted. Strategies to address barriers to participation, particularly among working women and minorities, are needed.