A Positive Psychology-Motivational Interviewing Intervention to Promote Positive Affect and Physical Activity in Type 2 Diabetes: The BEHOLD-8 Controlled Clinical Trial.

OBJECTIVE: Physical activity is associated with superior health outcomes in patients with type 2 diabetes (T2D), but most T2D patients do not follow physical activity recommendations. The objective of this study was to assess the feasibility and impact of a novel combined positive psychology-motivational interviewing (PP-MI) intervention to promote physical activity in T2D. METHODS: This controlled clinical trial compared an 8-week, phone-delivered PP-MI intervention to an attention-matched MI-enhanced behavioral counseling condition among 60 participants with T2D and suboptimal moderate to vigorous physical activity (MVPA; <150 min/wk). The primary study outcome was feasibility (proportion of sessions completed) and acceptability (0-10 ease and utility ratings of each session). Secondary outcomes were between-group differences in changes in positive affect (main psychological outcome) and accelerometer-measured physical activity (MVPA and steps per day), using mixed-effects regression models, at 8 and 16 weeks. RESULTS: Ninety-two percent of PP-MI sessions were completed, and mean participant ratings of ease/utility were 8.5 to 8.8/10, surpassing a priori benchmarks for feasibility and acceptability. PP-MI participants had small-medium effect size (ES) difference improvements in positive affect compared with MI (8 weeks: estimated mean difference [EMD] = 3.07 [SE = 1.41], p = .029, ES = 0.44; 16 weeks: EMD = 2.92 [SE = 1.73], p = .092, ES = 0.42). PP-MI participants also had greater improvements in MVPA (8 weeks: EMD = 13.05 min/d [SE = 5.00], p = .009, ES = 1.24; 16 weeks: EMD = 7.96 [SE = 4.53], p = .079, ES = 0.75), with similar improvements in steps per day. CONCLUSIONS: The PP-MI intervention was feasible and well accepted. Next-step efficacy studies can more rigorously explore the intervention's effects on physical activity and clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Registration No. NCT03150199.

Psychological Considerations in Hematopoietic Stem Cell Transplantation.

BACKGROUND: In recent decades, advances in transplantation medicine, and improved posttransplant care have reduced morbidity and mortality from hematopoietic stem cell transplantations (HSCTs). However, patients undergoing HSCT report a high prevalence of psychological distress, which can negatively impact recovery, function, and health outcomes, including mortality and higher risk of graft vs. host disease. Appropriate assessment and management of these psychological symptoms lead to better engagement with treatment and a variety of superior health outcomes. OBJECTIVE: We provide a narrative review of the psychological challenges that accompany HSCT and suggest management approaches to equip psychiatric consultants involved in the care of this patient population. METHODS: We reviewed published work in PubMed, PsycInfo, and Scopus electronic databases on the common psychological challenges in HSCT, their vulnerability factors, as well as practical interventions for managing these challenges. RESULTS: We outline the phases of the HSCT hospitalization and discuss common psychological challenges, such as depression, delirium, and post-traumatic stress reactions that accompany HSCT. We suggest an approach to psychiatric consults during the HSCT hospitalization and discuss practical interventions for managing psychological challenges in this population. CONCLUSIONS: Though pharmacological and behavioral interventions have been successfully used to treat psychosocial challenges in HSCT, further research is needed to understand the optimal psychiatric assessment tools, treatment strategies, and the long-term psychiatric care needed to address psychiatric comorbidities in this growing patient population.

An adaptive text message intervention to promote psychological well-being and reduce cardiac risk: The Text4Health controlled clinical pilot trial.

OBJECTIVE: In a two-arm pilot trial, we examined the feasibility, acceptability, and preliminary efficacy of a 12-week, adaptive text message intervention (TMI) to promote health behaviors and psychological well-being in 60 individuals with multiple cardiac risk conditions (i.e., hypertension, hyperlipidemia, and/or type 2 diabetes) and suboptimal adherence to exercise or dietary guidance. METHODS: Participants were allocated to receive the TMI or enhanced usual care (eUC). The TMI included daily adaptive text messages promoting health behaviors, twice-weekly messages to set goals and monitor progress, and monthly phone check-ins. Feasibility (primary outcome) and acceptability were measured by rates of successful text message delivery and daily participant ratings of message utility (0-10 Likert scale). We also assessed impact on health behavior adherence, psychological health, and functional outcomes. RESULTS: The TMI was feasible (99.3% of messages successfully sent) and well-accepted (mean utility = 7.4/10 [SD 2.6]). At 12 weeks, the TMI led to small-sized greater improvements in moderate to vigorous physical activity (d = 0.37), overall physical activity (d = 0.23), optimism (d = 0.20), anxiety (d = -0.36), self-efficacy (d = 0.22), and physical function (d = 0.20), compared to eUC. It did not impact other outcomes substantially at this time point. CONCLUSION: This 12-week, adaptive TMI was feasible, well-accepted, and associated with small-sized greater improvements in health behavior and psychological outcomes. Though larger studies are needed, it has the potential to be a scalable, low-intensity program that could be used in clinical practice. CLINICALTRIALS: govregistration:NCT04382521.

A novel health behaviour intervention to promote adherence in kidney failure.

BACKGROUND: Health behaviour adherence is associated with improved survival in kidney failure (KF); however, most patients with KF do not adhere to one or more health behaviours. Existing health behaviour interventions have significant limitations and do not focus on psychological factors that are associated with adherence and health. OBJECTIVES: To examine the feasibility, acceptability, and preliminary efficacy of a 12-week, phone-delivered, positive psychology-motivational interviewing (MI) intervention to promote psychological well-being and adherence in KF. DESIGN: Single-arm, proof-of-concept trial (N = 10). PARTICIPANTS: Participants were adults with KF undergoing haemodialysis and reporting suboptimal adherence to physical activity, diet, and/or medications. Participants attended weekly phone sessions with a study trainer, completed weekly positive psychology exercises (focused on gratitude, strengths, and meaning), and worked towards physical activity, diet, and/or medication goals. MEASUREMENTS: Feasibility was measured by the percentage of sessions completed, while acceptability was assessed through participant ratings of positive psychology and MI session ease and utility (0-10 Likert scales). We explored the intervention's impact on psychological outcomes and health behaviour adherence using validated scales and accelerometers. RESULTS: Participants completed 78% of sessions and rated the program's components as easy to complete (positive psychology: 8.7 ± 1.5; MI: 8.3 ± 2.0) and subjectively helpful (positive psychology: 8.8 ± 1.2; MI: 8.8 ± 1.6). The intervention led to promising but nonsignificant improvements in psychological and adherence measures. CONCLUSIONS: This 12-week, phone-delivered program was feasible, well-accepted, and associated with nonsignificant improvements health behaviour adherence, highlighting the need for a larger efficacy trial.

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

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.

An Adaptive Text Message Intervention to Promote Well-Being and Health Behavior Adherence for Patients With Cardiovascular Disease: Intervention Design and Preliminary Results.

BACKGROUND: Most individuals with heart disease struggle to adhere to cardiovascular health behaviors, despite their known health benefits. Text message interventions (TMIs) are a promising treatment modality for health behavior promotion, but existing TMIs typically deliver a fixed set of messages and do not target well-being constructs associated with adherence and cardiovascular health. OBJECTIVE: To develop a 4-week TMI, which delivers daily messages to promote well-being and adherence to health behaviors and dynamically adapts based on participant feedback to deliver increasingly customized messages; and to assess its feasibility, acceptability, and preliminary efficacy in a single-arm, proof-of-concept trial in 14 individuals with coronary artery disease (age mean = 67.9, standard deviation = 8.7). METHODS: Participants received daily text messages related to well-being, physical activity, or diet, rated each message's utility, and these ratings informed the TMI's choice of future text messages. Feasibility was assessed by the proportion of messages successfully sent, and acceptability was assessed by participant ratings of intervention burden and text message utility. Finally, the intervention's preliminary efficacy was explored by measuring pre-post changes in psychologic and behavioral outcomes. RESULTS: The TMI was both feasible (93% of participants received all messages) and well-accepted (mean text message utility: 7.0 of 10 [standard deviation 2.5]; mean intervention utility: 6.4 of 10 [standard deviation 0.9]; mean intervention burden: 0.5 of 10 [standard deviation 0.9]). Participants reported that messages related to well-being were particularly helpful and that most messages led to an action (e.g., eating more vegetables, being kind to others). The TMI led to nonsignificant, small-to-medium effect size improvements in happiness, optimism, determination, depression, anxiety, self-rated health, and diet (d = 0.19-0.48), and, unexpectedly, small reductions in activity and physical function (d = -0.20 and -0.32). CONCLUSIONS: The adaptive TMI was feasible, well-accepted, and associated with nonsignificant improvements in psychologic outcomes and mixed effects on behavioral outcomes. Larger, well-powered studies are needed to determine whether this TMI will be able to improve well-being and health-related outcomes in this high-risk population.

A Psychological-Behavioral Intervention to Improve Physical Activity in Midlife Adults With Low Baseline Physical Activity.

Background: Many midlife adults (aged 45-64 years) struggle to become physically active in the context of diminished psychological well-being and multiple concurrent stressors, despite the clear association of low physical activity with the development of chronic medical conditions.Objectives: To assess the feasibility (rates of session completion) and acceptability (participant 0-10 ratings of weekly session ease and utility) of a novel 12-week, phone-delivered, midlife-adapted positive psychology-motivational interviewing (PP-MI) intervention to promote physical activity. Secondary aims were pre-post changes in accelerometer-measured physical activity and self-reported psychological and functional measures.Methods: A single-arm proof-of-concept trial of the PP-MI intervention was conducted among 11 inactive midlife adults enrolled from the primary care practices of an urban academic medical center. Descriptive statistics were used to assess feasibility and acceptability outcomes, and mixed effects models were used to examine pre-post changes in psychological, functional, and physical activity outcomes from baseline to 12 weeks.Results: The intervention exceeded a priori thresholds for feasibility and acceptability, with 80.3% session completion across all participants and mean session ratings of 8.3/10 (SD = 2.1). Participants also had medium effect size magnitude improvements in physical activity and psychological outcomes.Conclusions: This remotely delivered, midlife-specific PP-MI intervention was feasible and well-accepted among inactive midlife adults, supporting next-step testing of this program in a randomized trial.Trial Registration: ClinicalTrials.gov identifier: NCT04745182.

Association of Midlife Status With Response to a Positive Psychology Intervention in Patients With Acute Coronary Syndrome.

BACKGROUND: Physical activity is strongly associated with lower risk of recurrent cardiac events in patients who experience an acute coronary syndrome (ACS), yet most patients do not meet recommended levels of physical activity. Psychological well-being is associated with higher levels of physical activity, but midlife adults experience a multitude of stressors that can reduce well-being. OBJECTIVE: The aim of this study was to compare midlife (age 45-64) and older (age 65+) participants in a positive psychology intervention to increase physical activity and psychological well-being after an ACS. METHODS: This was a secondary analysis across 3 phases of a telephone-delivered positive psychology intervention development project. Participants were hospitalized for an ACS and had low pre-ACS health behavior adherence. They received 8-12 weekly intervention sessions. Psychological outcomes, self-reported adherence, and physical activity were measured before and after treatment. Mixed regression models were used to compare session completion rates and change in outcome measures between midlife and older participants. RESULTS: Across 164 participants, midlife participants showed larger improvements in depression, positive affect, and physical activity, but not anxiety or optimism, than older participants; session completion rates did not significantly differ. CONCLUSIONS: Midlife patients post-ACS may be particularly responsive to a telephone-delivered positive psychology intervention. Clinically, the post-ACS period may be uniquely motivating for midlife patients to improve their physical and psychological health. Future work could customize positive psychology for unique midlife stressors.

A positive psychology-motivational interviewing program to promote physical activity in type 2 diabetes: The BEHOLD-16 pilot randomized trial.

BACKGROUND: The majority of persons with type 2 diabetes (T2D) do not meet recommended levels of physical activity, despite clear links between physical activity and superior medical outcomes in this population. The objective of this trial was to assess the feasibility and impact of a novel 16-week combined positive psychology-motivational interviewing (PP-MI) program to promote physical activity among inactive persons with T2D. METHODS: This pilot randomized trial compared the 16-week, phone-delivered PP-MI intervention to an attention-matched diabetes counseling condition among 70 persons with T2D and low levels of baseline moderate to vigorous physical activity (MVPA; <150 min/week). The primary study outcomes were feasibility (assessed via rates of session completion) and acceptability (assessed via mean participant ratings [0-10] of the ease and utility of weekly sessions). Key secondary outcomes included between-group differences in improvement in positive affect, other psychological outcomes, and accelerometer-measured physical activity, assessed using mixed effects regression models, at 16 and 24 weeks. RESULTS: Participants completed a mean 11.0 (SD 4.4; 79%) of 14 PP-MI phone sessions, and composite mean ratings of ease/utility were 8.6/10, above our a priori benchmarks for feasibility/acceptability (70% session completion; 7.0/10 mean ratings). PP-MI participants had small to medium effect size (ES) difference improvements in MVPA (ES difference = 0.34) and steps/day (ES difference = 0.76) at 16 weeks, with sustained but smaller effects at 24 weeks (ES difference = 0.22-0.33). CONCLUSIONS: Next-step studies of this PP-MI program in T2D patients can more rigorously explore the intervention's effects on physical activity and clinical outcomes.

Psychiatric and Psychological Interventions for Depression in Patients With Heart Disease: A Scoping Review.

Depression in patients with cardiovascular disease is independently associated with progression of heart disease, major adverse cardiac events, and mortality. A wide variety of depression treatment strategies have been studied in randomized controlled trials as the field works to identify optimal depression treatments in this population. A contemporary scoping review of the literature can help to consolidate and synthesize the growing and disparate literature on depression treatment trials in people with cardiovascular disease. We conducted a scoping review utilizing a systematic search of the literature via 4 databases (PubMed, PsycINFO, EMBASE, and Google Scholar) from database inception to March 2020. We identified 42 relevant randomized controlled trials of depression treatment interventions in patients with cardiac disease (n=9181 patients with coronary artery disease, n=1981 patients with heart failure). Selective serotonin reuptake inhibitors appear to be safe in patients with cardiac disease and to have beneficial effects on depression (and some suggestion of cardiac benefit) in patients with coronary artery disease, with less evidence of their efficacy in heart failure. In contrast, psychotherapy appears to be effective for depression in coronary artery disease and heart failure, but with less evidence of cardiac benefit. Newer multimodal depression care management approaches that utilize flexible approaches to patients' care have been less studied but appear promising across cardiac patient groups. Selective serotonin reuptake inhibitors may be preferred in the treatment of patients with coronary artery disease, psychotherapy may be preferred in heart failure, and more flexible depression care management approaches have shown promise by potentially using both approaches based on patient needs.

Exploring the feasibility and impact of positive psychology-motivational interviewing interventions to promote positive affect and physical activity in type 2 diabetes: design and methods from the BEHOLD-8 and BEHOLD-16 clinical trials.

BACKGROUND: Physical activity among those with type 2 diabetes (T2D) is independently associated with superior medical outcomes, but existing behavioral interventions have not led to widespread increases in activity in this population. A remotely delivered intervention that targets well-being constructs associated with greater activity and assists in the creation of specific physical activity goals has the potential to improve activity and outcomes in T2D. OBJECTIVE: To outline the rationale and methods of two studies designed to assess the impact and optimal duration of a combined positive psychology-motivational interviewing (PP-MI) intervention for inactive persons with T2D. METHODS: We conducted trials studying 8-week (BEHOLD-8;) and 16-week (BEHOLD-16;) phone-delivered interventions, compared to attention-matched control conditions. In a two-step randomization design, participants were allocated randomly first to study (BEHOLD-8 or BEHOLD-16), then to study condition within study. The primary aims in both trials were feasibility (rates of session completion) and acceptability (participant session ratings), with additional aims examining intervention effects on accelerometer-measured physical activity, psychological measures, and health-related metrics (e.g. vital signs). Main analyses, currently being conducted, will utilize mixed effects models between study conditions, and secondary analyses will utilize the same models to compare the 8- and 16-week PP-MI interventions on feasibility and impact. RESULTS: Enrollment and data collection have been completed for both trials (BEHOLD-8: N = 60; BEHOLD-16: N = 70), and data analysis is ongoing to assess feasibility and acceptability within study, as well as the relative feasibility and acceptability of the PP-MI interventions across the two studies. We will also explore impact on clinical outcomes between groups. CONCLUSIONS: This design will address how intervention content (i.e. PP elements vs. no PP elements) and intervention duration (8 weeks vs. 16 weeks) affect feasibility, acceptability, and impact, allowing intervention optimization before a next-step larger clinical trial. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03150199; NCT03001999.

Randomized controlled trial of a well-being intervention in cardiac patients.

OBJECTIVE: Positive psychological well-being interventions have demonstrated promise in improving both psychological and physical health-related outcomes in patients with coronary artery disease (CAD), but evidence of the efficacy of these interventions with individuals with CAD is limited. As such, we developed an eight-week group-based intervention targeting eudaimonic aspects of psychological well-being in a randomized pilot trial. The primary aims of the trial were feasibility and acceptability, and we also explored the intervention's effectiveness on psychological outcomes. METHOD: Participants were 40 CAD outpatients randomly assigned to the intervention (n = 20) or an attention-matched control group (n = 20). Feasibility was measured by rates of group session attendance and homework completion, and acceptability was assessed through participant ratings of intervention activities. Additional study outcomes, compared between groups, included psychological well-being, optimism, depression, and positive and negative affect. RESULTS: The intervention met a priori criteria for feasibility and acceptability. The intervention was also associated with greater improvements in psychological well-being (ß = -16.90; 95% Confidence Interval [CI] = -23.36, -10.44; p < .001, ES = 1.65), optimism (ß = -8.80; 95% CI = -11.17, -6.43; t = -7.41; p < .001; ES = 2.34), and depression (ß = 26.45; 95% CI = 20.97, 31.93; p < .001) immediately post-intervention, with sustained effects six weeks later. CONCLUSIONS: These results indicate that the intervention was feasible, well-accepted, and effective in improving clinically relevant psychological outcomes in individuals with CAD. Future work should seek to replicate this work and assess general health-related and cardiac health-specific outcomes.

Well-being interventions for individuals with diabetes: A systematic review.

In patients with diabetes, psychological well-being constructs (e.g., optimism, positive affect) have been associated with superior medical outcomes, including better glucose control and lower mortality rates. Well-being interventions may be well-suited to individuals with diabetes, as they are simple to deliver, broadly applicable across a range of psychological distress, and may help increase self-efficacy and motivation for diabetes self-care. This systematic review, completed using PRISMA guidelines, examined peer-reviewed studies indexed in PubMed, PsycINFO, and/or Scopus between database inception and October 2017 that investigated the effects of well-being interventions (e.g., positive psychology interventions, mindfulness-based interventions, resilience-based interventions) on psychological and physical health outcomes in individuals with Type 1 or Type 2 diabetes. The search yielded 34 articles (N = 1635 participants), with substantial variability in intervention type, measures used, and outcomes studied; the majority found the intervention to provide benefit. Overall, results indicate that a range of well-being interventions appear to have promise in improving health outcomes in this population, but the literature does not yet provide definitive data about which specific interventions are most effective. The variability in interventions and outcomes points to a need for further rigorous, controlled, and well-powered studies of specific interventions, with well-accepted, clinically relevant outcome measures.

Psychological Well-Being and Type 2 Diabetes.

Positive psychological characteristics such as optimism, positive affect, gratitude, and related constructs may play an important role in health. In patients with type 2 diabetes (T2D), positive psychological constructs have been associated with superior medical outcomes, including better glucose control and lower mortality rates. The beneficial effects of positive psychological states in T2D are most likely mediated through health behaviors such as increased physical activity and adherence to a healthier diet. Furthermore, numerous studies with non-diabetic populations have shown that performing various positive psychological exercises (e.g., writing gratitude letters, performing acts of kindness) have led to greater well-being. Compared to other available treatments, these activities are simple and involve constructs that have been associated with superior adherence and diabetes-related outcomes. However, there has been minimal research on the use of positive psychological interventions in T2D, though small studies of related interventions have been linked to improvements in positive affect and, in some cases, greater health behavior adherence and lower blood sugar. Continued work is needed to ascertain whether positive psychology interventions can truly impact functioning, blood sugar, and overall health in this key population.