Trial Of Behavioral Intervention Research Articles

Abstract B059: Every day counts to cada dia cuenta: Adapting a behavioral intervention trial to accommodate Spanish language participants in a multisite study

Abstract Introduction. The number of women living with metastatic breast cancer (MBC) has doubled in the last decade. Hispanic women have lower incidence of breast cancer than non-Hispanic White women but are more likely to be diagnosed at an advanced stage. Targeted therapies can impose prolonged symptom burden resulting in significant distress and physical limitations for women with MBC. Minimizing symptom burden, while maximizing treatment response and quality of life (QoL) are the primary goals in the metastatic setting. Thus, the demand for evidence-based interventions to help improve QoL, prognosis and survivorship is critical. Every Day Counts (EDC) examines the impact of a diet and exercise intervention on QoL and explores potential mechanistic pathways (e.g., body composition, inflammation) linking lifestyle to QoL. Initially, study eligibility excluded non-English speakers. Given the burden of MBC among Latinas, including Spanish language participants was a priority; the process of achieving this goal is described herein. Methods: Participants complete surveys and physical assessments at baseline and are then randomized to the 16-week lifestyle intervention OR the attention control organizational program. Both are led by a trained coach and include a program binder and weekly text messages whereas only the intervention receives a Fitbit and cooking classes. After the16-week program, participants complete surveys and physical assessments, and the control group participants crossover to the lifestyle program. Surveys include QoL, diet, physical activity, pain, cognitive function, sleep, outcome expectancy, social support, mood, and self- efficacy. Physical assessments include a 24-hour diet recall, DEXA, 6-minute walk, sit-to-stand, handgrip, arm curl, single leg balance, and blood draw. Adapting the trial for Spanish language participants required multiple steps and was led and implemented by bilingual, bicultural staff that went beyond translation and back-translation. Material Inventory. Review participant- facing materials to inform plan for adaptation and translation. Survey Review (N=17). Identify which measures are available and validated in Spanish using Pubmed and other search engines and/or contacting instrument author(s). Intervention Review. Staff review for content relevance for Latinas, include images and recipes illustrative of Latina culture. Translation. The study used a translation/back-translation process for recruitment scripts and materials, consent form, all surveys not available in Spanish, physical assessment protocols, intervention and control materials and text messages. Translation Review. To ensure the context of translation across dialects common to the Midwest, materials were reviewed by community members (Mexico, Puerto Rico, Dominican Republic), with discrepancies resolved by staff. Discussion:: Transitioning studies to be more inclusive will increase critical access to much-needed trials that will impact disparities evident among minoritized communities. Citation Format: Diana L. Navarro Suarez, Patricia Sheean, Estefania Alonso, Sandra Contreras, Kathleen O’Connell, Margaret Tovar, Melinda Stolley. Every day counts to cada dia cuenta: Adapting a behavioral intervention trial to accommodate Spanish language participants in a multisite study [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B059.

The National Cancer Institute Clinical Trials Planning Meeting to Address Gaps in Observational and Intervention Trials for Cancer-Related Cognitive Impairment

Abstract Cancer-related cognitive impairment (CRCI) is a broad term encompassing subtle cognitive problems to more severe impairment. CRCI severity is influenced by host, disease, and treatment factors and affects patients prior to, during, and following cancer treatment. The National Cancer Institute (NCI) Symptom Management and Health-Related Quality of Life Steering Committee (SxQoL SC) convened a Clinical Trial Planning Meeting (CTPM) to review the state of the science on CRCI and to develop both Phase II/III intervention trials aimed at improving cognitive function in cancer survivors with non-central nervous system (CNS) disease and longitudinal studies to understand the trajectory of cognitive impairment and contributing factors. Participants included experts in the field of CRCI, members of the SxQOL SC, patient advocates, representatives from all seven NCI Community Oncology Research Program (NCORP) Research Bases, and the NCI. Presentations focused on the following topics: measurement, lessons learned from pediatric and geriatric oncology, biomarker and mechanism endpoints, longitudinal study designs, and pharmacologic and behavioral intervention trials. Panel discussions provided guidance on priority cognitive assessments, considerations for remote assessments, inclusion of relevant biomarkers, and strategies for ensuring broad inclusion criteria. Three CTPM working groups (longitudinal studies and pharmacologic and behavioral intervention trials) convened for one year to discuss and report on top priorities and to design studies. The CTPM experts concluded sufficient data exist to advance Phase II/Phase III trials utilizing selected pharmacologic and behavioral interventions for the treatment of CRCI in the non-CNS setting with recommendations included herein.

Characterization of neural networks involved in transdiagnostic emotion dysregulation from a pilot randomized controlled trial of a neurostimulation-enhanced behavioral intervention

BackgroundEmotional dysregulation is a serious and impairing mental health problem. We examined functional activity and connectivity of neural networks involved in emotional dysregulation at baseline and following a pilot neurostimulation-enhanced cognitive restructuring intervention in a transdiagnostic clinical adult sample. MethodsNeuroimaging data were analyzed from adults who scored 89 or higher on the Difficulties with Emotion Regulation (DERS) scale and had at least one DSM-5 diagnosis. These participants were part of a pilot randomized, double-blind, placebo-controlled trial combining a single therapeutic session of cognitive restructuring with active or sham transcranial magnetic stimulation over the dorsolateral prefrontal cortex. During the study, participants engaged in an emotional regulation task using personalized autobiographical stressors while undergoing functional magnetic resonance imaging (fMRI) before and after the pilot intervention. The fMRI task required participants to either experience the emotions associated with the memories or apply cognitive restructuring strategies to reduce their distress. ResultsWhole-brain fMRI results during regulation at baseline revealed increased activation in the dorsal frontoparietal network but decreased activation in the supplementary motor area, cingulate cortex, insula, and ventrolateral prefrontal cortex (vlPFC). Emotion dysregulation was associated with greater vmPFC and amygdala activation and functional connectivity between these regions. The strength of functional connectivity between the dlPFC and other frontal regions was also a marker of emotional dysregulation. Preliminary findings from a subset of participants who completed the follow-up fMRI scan showed that active neurostimulation improved behavioral indices of emotion regulation more than sham stimulation. A whole-brain generalized psychophysiological interaction analysis indicated that active neurostimulation selectively increased occipital cortex connectivity with both the insula and the dlPFC. Region-of-interest functional connectivity analyses showed that active neurostimulation selectively increased dlPFC connectivity with the insula and orbitofrontal cortex (OFC). ConclusionInsufficient neural specificity during the emotion regulation process and over-involvement of frontal regions may be a marker of emotional dysregulation across disorders. OFC, vlPFC, insula activity, and connectivity are associated with improved emotion regulation in transdiagnostic adults. In this pilot study, active neurostimulation led to neural changes in the emotion regulation network after a single session; however, the intervention findings are preliminary, given the small sample size. These functional network properties can inform future neuroscience-driven interventions and larger-scale studies.

Socio-cognitive facilitators of ART-adherence among predominantly black sexual and gender minoritized persons living with HIV in Atlanta, Georgia: a latent profile analysis.

The Integrated Change Model describes several social and cognitive factors (e.g., health attitudes, social support, self-efficacy) that can affect medication adherence. Guided by this model, we sought to identify profiles of socio-cognitive facilitators of ART (antiretroviral therapy) adherence among diversely minoritized persons living with HIV enrolled in a behavioral intervention trial in Atlanta, Georgia (N = 477). To do this, we performed latent profile analysis on baseline responses to scales assessing 6 indicators of interest: HIV-care self-efficacy, social support, TasP (treatment-as-prevention) beliefs, trust in healthcare providers, perceived need for ART, and trust in ART. We regressed emergent profiles on internalized, enacted, and microaggressive HIV stigma and compared prospective 30-day ART adherence and several cross-sectional HIV outcomes across profiles. Mean age was 29 years; 83% of participants were non-Hispanic Black, 53% were gay/homosexual-identifying, and 12% were gender expansive. Three profiles emerged: "Constrained/Capable" (6%), featuring high self-efficacy but low-moderate provider trust, social support, TasP beliefs, ART trust, and ART need; "Conflicted" (13%), featuring high TasP beliefs, provider trust, and ART need but moderate self-efficacy, ART trust, and social support; and "Motivated" (81%), featuring high levels of all indicators. Greater internalized, enacted, and microaggressive stigma were positively associated with "Conflicted" relative to "Motivated" profile membership. ART-nonadherence, unsuppressed viral load, and viral load unawareness were more likely for the "Conflicted" relative to the "Motivated" profile. Personalized HIV care tailored to such profiles may improve ART adherence and related outcomes for minoritized persons living with HIV.

Factors associated with participation in a walking intervention for veterans who smoke and have chronic pain.

This analysis was part of the Pain and Smoking Study (PASS), a randomized trial of a cognitive behavioral intervention (CBI) for Veterans with chronic pain who smoke. The objective of this study was to examine factors associated with participation in the walking component of the intervention. Demographics and clinical characteristics were obtained at baseline. Completion of two or more CBI counseling sessions was required to be included in analyses. Average daily step counts obtained via pedometer in the prior week were recorded in up to three telephone counseling sessions. Participants were then categorized as "sedentary" (≤ 4999 daily steps) or "not sedentary" (≥ 5000 daily steps). Multivariable logistic regression was used to model variance in activity categorization. Overall, 91.0% of participants were men, 70.5% were white, mean age was 58.4 years, mean BMI was 28.6, median pack years was 20.5, and 43.8% were depressed. Veterans reported moderate pain intensity (4.9/10) and pain interference (5.4/10). Pain locations included: lower extremity (67.4%), back (53.4%) and upper extremity (28.1%). Median daily steps were 2491 [IQR: 1720-3550] (sedentary) (n = 65), 7307 [IQR: 5952-8533] (not sedentary) (n = 24), and 3196 [IQR: 2237-5067] (overall) (n = 89). Veterans with older age (odds ratio (OR): 1.10, 95% confidence interval (CI): 1.04, 1.17) and presence of LE pain (OR: 5.98, 95% CI: 1.82, 19.65) had increased odds of being "sedentary." Integrated smoking cessation and chronic pain self-management interventions that include a walking component may need to consider the impact of age and pain location on participation.Trial registration: The trial is registered at www.ClinicalTrials.gov (NCT02971137). First posted on November 22, 2016.

Randomized Controlled Trial of a Nurse-Led Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer.

In patients with lung cancer, dyspnea is one of the most prevalent and disabling symptoms, for which effective treatments are lacking. We examined the efficacy of a nurse-led brief behavioral intervention to improve dyspnea in patients with advanced lung cancer. Patients with advanced lung cancer reporting at least moderate breathlessness (n = 247) were enrolled in a randomized trial of a nurse-led two-session intervention (focused on breathing techniques, postural positions, and fan therapy) versus usual care. At baseline and weeks 8 (primary end point), 16, and 24, participants completed measures of dyspnea (Modified Medical Research Council Dyspnea Scale [mMRCDS]; Cancer Dyspnoea Scale [CDS]), quality of life (Functional Assessment of Cancer Therapy-Lung [FACT-L]), psychological symptoms (Hospital Anxiety and Depression Scale), and activity level (Godin-Shephard Leisure Time Physical Activity Questionnaire). To examine intervention effects, we conducted analysis of covariance and longitudinal mixed effects models. The sample (Agemean = 66.15 years; 55.9% female) primarily included patients with advanced non-small cell lung cancer (85.4%). Compared with usual care, the intervention improved the primary outcome of patient-reported dyspnea on the mMRCDS (difference = -0.33 [95% CI, -0.61 to -0.05]) but not the CDS total score at 8 weeks. Intervention patients also reported less dyspnea on the CDS sense of discomfort subscale (difference = -0.59 [95% CI, -1.16 to -0.01]) and better functional well-being per the FACT-L (difference = 1.39 [95% CI, 0.18 to 2.59]) versus the control group. Study groups did not differ in overall quality of life, psychological symptoms, or activity level at 8 weeks or longitudinally over 24 weeks. For patients with advanced lung cancer, a scalable behavioral intervention alleviated the intractable symptom of dyspnea. Further research is needed on ways to enhance intervention effects over the long-term and across additional outcomes.

A randomized trial of behavioral interventions yielding sustained reductions in distracted driving

Distracted driving is responsible for nearly 1 million crashes each year in the United States alone, and a major source of driver distraction is handheld phone use. We conducted a randomized, controlled trial to compare the effectiveness of interventions designed to create sustained reductions in handheld use while driving (NCT04587609). Participants were 1,653 consenting Progressive® Snapshot® usage-based auto insurance customers ages 18 to 77 who averaged at least 2 min/h of handheld use while driving in the month prior to study invitation. They were randomly assigned to one of five arms for a 10-wk intervention period. Arm 1 (control) got education about the risks of handheld phone use, as did the other arms. Arm 2 got a free phone mount to facilitate hands-free use. Arm 3 got the mount plus a commitment exercise and tips for hands-free use. Arm 4 got the mount, commitment, and tips plus weekly goal gamification and social competition. Arm 5 was the same as Arm 4, plus offered behaviorally designed financial incentives. Postintervention, participants were monitored until the end of their insurance rating period, 25 to 65 d more. Outcome differences were measured using fractional logistic regression. Arm 4 participants, who received gamification and competition, reduced their handheld use by 20.5% relative to control (P < 0.001); Arm 5 participants, who additionally received financial incentives, reduced their use by 27.6% (P < 0.001). Both groups sustained these reductions through the end of their insurance rating period.

Training physicians in motivational communication: An integrated knowledge transfer study protocol.

While behavior change counseling (BCC) targeting health risk behaviors has shown efficacy for improving patient health outcomes, barriers to knowledge translation have resulted in poor uptake among health care providers (HCPs). This article outlines the development of a new BCC training framework for HCPs, from inception to readiness for efficacy testing. It provides an example of integrated knowledge translation (iKT) used in alignment with the obesity-related behavioral intervention trials model. (a) A modified Delphi process identified essential BCC skills for HCPs; (b) a survey assessed HCP attitudes and training needs; (c) an online competency assessment tool was developed using iKT mixed methods; (d) a training program was developed and refined using a logic model; and (e) the program was optimized using iterative rounds of participant feedback. A future proof-of-concept trial (f) will determine the program's readiness for full efficacy testing. A Delphi panel (n = 46) identified 11 core BCC competencies for HCPs, defining "motivational communication." The HCP survey (n = 80) showed willingness to devote 4 hr to introductory training in BCC. The Motivational Communication Competency Assessment Test (MC-CAT: an online, interactive evaluation tool) and a motivational communication training program (MOTIVATOR: accredited for continuing education by the Royal College of Physicians and Surgeons of Canada) were collaboratively developed with knowledge users. The optimization process (n = 11) provided key feedback, with minor changes being made to the program. In developing a new BCC framework, obstacles to BCC implementation were addressed through an iterative iKT process. This should improve eventual intervention uptake. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Diversity and inclusion in behavioural intervention trials in multiple sclerosis: A commentary.

Diversity and inclusion in behavioural intervention trials in multiple sclerosis: A commentary.

Impact of an intergenerational program to improve loneliness and social isolation in older adults initiated at the time of emergency department discharge: study protocol for a three-arm randomized clinical trial

BackgroundSocial isolation and loneliness (SIL) worsens mortality and other outcomes among older adults as much as smoking. We previously tested the impact of the HOW R U? intervention using peer support from similar-aged volunteers and demonstrated reduced SIL among older adults discharged from the emergency department (ED). Generativity, defined as “the interest in establishing and guiding the next generation,” can provide an alternative theoretical basis for reducing SIL via intergenerational programs between members of younger and older generations. The current protocol will examine the impact of younger intergenerational volunteers providing the HOW RU? intervention.MethodsIn this randomized clinical trial, we will compare the following three arms: (1) the standard same-generation peer support HOW R U? intervention, (2) HOW R U? intervention delivered by intergenerational volunteers, and (3) a common wait-list control group. Outcome assessors will be blinded to the intervention. Trained volunteers will deliver 12 weekly telephone support calls. We will recruit participants ≥ 70 years of age with baseline loneliness (six-item De Jong loneliness score of 2 or greater) from two EDs. Research staff will assess SIL, depression, quality of life, functional status, generativity, and perceived benefit at baseline, at 12 weeks, and 24 weeks post-intervention.DiscussionWe hypothesize participants receiving the intergenerational intervention will show improved outcomes compared to the control group and peer support HOW R U? intervention. We also hypothesize that participants with higher perceptions of generativity will have greater reductions in SIL than their lower generativity counterparts. Aging is experienced diversely, and social interventions combatting associated SIL should reflect that diversity. As part of a program of research following the Obesity-Related Behavioral Intervention Trials (ORBIT) model, the findings of this RCT will be used to define which intervention characteristics are most effective in reducing SIL.Trial registrationClinicalTrials.gov NCT05998343 Protocol ID:21-0074E. Registered on 24 July 2023.

Psychological processes and alcohol reduction in patients with chronic hepatitis C: Results from the HepART trial.

There is a lack of randomized controlled trials of behavioral interventions and process-level research related to alcohol reduction among patients with chronic liver disease (e.g., hepatitis C viral (HCV) infection). We conducted a process-level, secondary analysis of the Hepatitis C-Alcohol Reduction Treatment (HepART) trial to investigate the association between change in psychological processes posited by the Integrated Behavioral Model (IBM) and change in World Health Organization (WHO) drinking risk levels. Patients with HCV who consume alcohol were recruited from hepatology clinics and received provider-delivered SBIRT (Screening, Brief Intervention, Referral to Treatment) or SBIRT+ 6 months of co-located alcohol counseling. Treatment arms were combined for this analysis because no between-group differences were found. At baseline and 6 months, the timeline followback method was used to determine alcohol risk levels according to the 2000 WHO risk categories (based on average grams of alcohol per day). Changes in alcohol consumption and WHO risk levels were quantified and regressed on change in individual psychological processes (e.g., readiness, self-efficacy, motives, attitudes, and strategies) from baseline to 6 months. At the baseline assessment, 162 participants were classified as abstinent (5%), low (47%), moderate (16%), high (19%), or very high (13%) WHO risk levels. At 6 months, 38% remained at the same risk level and 48% decreased by at least one level. In univariate analyses, changes in 7 of 12 psychological processes were associated with change in risk levels. Adjusted multivariate analyses demonstrated that change in four processes were significantly associated with change in risk levels, including SOCRATES Taking Steps, Ambivalence, and Recognition scores and alcohol reduction strategies. These findings demonstrate significant reductions in quantitative indices of alcohol consumption following opportunistic alcohol interventions in patients with HCV. However, results provided mixed support for associations between change in IBM psychological processes and alcohol consumption.

A Descriptive Review and Meta-Regression Study of Demographic and Study Context Factors in US Clinical Trials of Cognitive Behavioral Interventions for Alcohol or Other Drug Use

Objectives. Cognitive-Behaviorally Based Interventions (CBIs) are evidence-based treatments for alcohol and other drug (AOD) use with potential variable effectiveness by population sub-groups. This study used evidence synthesis to examine treatment effect by demographic and study context factors in clinical trials of CBI for AOD. Methods. Studies were systematically identified, and their characteristics and outcome data were extracted and summarized. Standardized mean differences were calculated for within- and between-condition effects on substance use outcomes. Demographic and study context moderators were identified during data acquisition and several sensitivity analyses were conducted. Results. The sample included K = 29 trials and a total of 15 study-level moderators were examined. Information on participants’ age, biological sex, and race were reported in at least 26 trials, but information on gender identity, sexual orientation, and ethnicity were reported infrequently or in non-inclusive ways. The mean between-condition effect size was small and moderately heterogenous (d = 0.158, 95% CI = 0.079, 0.238, I2 = 46%) and the mean within-condition effect size was large and showed high heterogeneity (dz = 1.147, 95% CI = 0.811, 1.482, - I2 = 96%). The specific drug targeted in the study and whether biological assay-based outcomes were used moderated between-condition CBI efficacy and the inclusion of co-occurring mental health conditions and study publication date moderated within-condition CBI effects. Conclusions. Results provide preliminary data on study context factors associated with effect estimates in United States based clinical trials of CBI for AOD.

Process evaluation of a pragmatic feasibility trial on smokeless tobacco cessation intervention delivered in dental hospitals

BackgroundArticle 14 of the WHO ‘Framework Convention on Tobacco Control’ recommends, that all oral healthcare providers provide support for tobacco cessation, to all patients. Despite evidence on the effectiveness of tobacco cessation interventions in dental settings, implementation remains low in most high-burden countries like Pakistan. A pragmatic pilot trial of a dentist-delivered behavioural support intervention for smokeless tobacco (ST) cessation, was conducted in dental hospitals in Pakistan. This paper presents the findings of the process evaluation of the trial.MethodsA mixed-method process evaluation of a multi-centre randomised control pilot trial of dentist-delivered behavioural support intervention ST cessation was conducted. The intervention included three sessions namely: pre-quit, quit and post-quit sessions. The process evaluation involved: semi-structured interviews with trial participants (n = 26, of which dental patients were n = 13 and participating dentists were n = 13 conducted from June-August 2022); and fidelity assessment of audio recordings of the intervention sessions (n = 29). The framework approach was used to thematically analyse the interview data.ResultsOverall the trial procedures were well accepted, however, young patients expressed uneasiness over revealing their ST use status. The intervention was received positively by dentists and patients. Dentists identified some challenges in delivering behavioural support to their patients. Of these, some were related to the contents of the intervention whereas, others were related to the logistics of delivering the intervention in a clinical setting (such as workload and space). Acceptability of the intervention resources was overall low amongst young patients as they did not take the intervention resources home due to fear of their family members finding out about their ST use. The intervention was successful in achieving the intended impact (in those who engaged with the intervention), i.e., change in the patients’ ST use behaviour. Giving up ST with the aid of behavioural support also had an unintended negative effect i.e., the use of harmful substances (cannabis, cigarettes) to give up ST use. Patients’ satisfaction with their dental treatment seemed to influence the intervention outcome.ConclusionWhile there are many variables to consider, but for the participants of this study, behavioural support for abstinence delivered through dentists during routine dental care, appears to be an acceptable and practical approach in helping patients give up ST use, in a country like Pakistan, where negligible support is offered to ST users.

Physical Activity Dependence on Relative Temperature and Humidity Characteristics in a Young, Insufficiently Active Population: A Weather Typing Analysis.

Physical activity (PA) is an important contributor to one's physical and mental health both acutely and across the lifespan. Much research has done on the ambient environment's impact on PA; however, these studies have used absolute values of atmospheric measures such as temperature and humidity, which vary spatiotemporally and make comparisons between studies which differ in location or time of year difficult to square with one another. Here, we employ the Global Weather Type Classification, Version 2, to determine the combined impact of temperature and humidity on PA in a sample of insufficiently active young adults. We conducted secondary analyses of data from a single-group behavioral intervention trial that varied the number of digital messages sent daily. Young adults (n = 81) wore Fitbit Versa smartwatches for a 6-month period sometime between April 2019 and July 2020, and location was tracked using a custom smartphone application. Mixed linear models indicated that, across 8179 person-days, PA was significantly lower on days with humid conditions and significantly higher on warm dry days, though the latter relationship was no longer significant when controlling for timing in relation to the COVID-19 pandemic declaration. Demographic factors did not affect the relationship between weather and PA. Results are a first step in providing additional guidance for encouraging PA in insufficiently active individuals given forecasted daily weather conditions. Future work should examine seasonal variability in the weather type-PA relationship without the influence of a world-altering event influencing results.

An Investigation of Employment Hope as a Key Factor Influencing Perceptions of Subjective Recovery among Adults with Serious Mental Illness Seeking Community Work.

Employment is an important contributor to recovery in people with serious mental illness (SMI), yet studies have not explored how subjective elements of employment hope contribute to perceptions of global recovery in this population. The current study examined the relationship between employment hope and subjective recovery in 276 unemployed adults with SMI participating in a multi-site clinical trial of a cognitive behavioral group intervention tailored toward work and combined with vocational rehabilitation. Participants had diagnoses of schizophrenia spectrum, bipolar, depressive, and posttraumatic stress disorders, and were receiving services at three Veterans Affairs healthcare facilities in the United States. Data were collected at study baseline. Linear regression analysis examined the relationship between employment hope (Short Employment Hope Scale; EHS-14) and subjective recovery (Recovery Assessment Scale; RAS) after controlling for psychiatric symptom severity and mental-health-related burden on daily life. After accounting for covariates, employment hope significantly contributed to the regression model explaining subjective recovery. The overall model of predictor variables explained 52.5% of the variance in recovery. The results further explore the relationships between EHS-14 and RAS subscales. The findings suggest that employment hope is a key intervention target to bolster subjective recovery in this vulnerable population.

Acceptability and Feasibility of the Telehealth Bariatric Behavioral Intervention to Increase Physical Activity Before Bariatric Surgery: A Single-Case Experimental Study (Part I).

Physical activity (PA) can play an important role in optimizing metabolic/bariatric surgery (MBS) outcomes. However, many MBS patients have difficulty increasing PA, necessitating the development of theory-driven counseling interventions. This study aimed to (1) assess the feasibility and acceptability of the TELEhealth BARIatric behavioral intervention (TELE-BariACTIV) trial protocol/methods and intervention, which was designed to increase moderate-to-vigorous intensity physical activity (MVPA) in adults awaiting MBS and (2) estimate the effect of the intervention on MVPA. This trial used a repeated single-case experimental design. Twelve insufficiently active adults awaiting MBS received 6 weekly 45-min PA videoconferencing counseling sessions. Feasibility and acceptability data (i.e., refusal, recruitment, retention, attendance, and attrition rates) were tracked and collected via online surveys, and interviews. MVPA was assessed via accelerometry pre-, during, and post-intervention. Among the 24 patients referred to the research team; five declined to participate (refusal rate = 20.8%) and seven were ineligible or unreachable. The recruitment rate was 1.2 participants per month between 2021-09 and 2022-07. One participant withdrew during the baseline phase, and one after the intervention (retention rate = 83.3%). No participant dropouts occurred during the intervention and 98.6% of sessions were completed. Participants' anticipated and retrospective acceptability of the intervention was 3.2/4 (IQR, 0.5) and 3.0/4 (IQR, 0.2), respectively. There was a statistically significant increase in MVPA [Tau-U = 0.32(0.11; 0.51)] from pre- to post-intervention. Despite a low recruitment rate, which could be explained by circumstances (COVID-19 pandemic), results support feasibility, acceptability, and preliminary efficacy of the TELE-Bari-ACTIV intervention for increasing MVPA in patients awaiting MBS.

Acceptability and feasibility of a mobile behavioral economic health intervention to reduce alcohol use in adults in rural areas

BackgroundAt-risk alcohol use is associated with increased adverse health consequences, yet is undertreated in healthcare settings. People residing in rural areas need improved access to services; however, few interventions are designed to meet the needs of rural populations. Mobile interventions can provide feasible, low-cost, and scalable means for reaching this population and improving health, and behavioral economic approaches are promising. MethodsWe conducted a pilot randomized controlled trial focused on acceptability and feasibility of a mobile behavioral economic intervention for 75 rural-residing adults with at-risk alcohol use. We recruited participants from a large healthcare system and randomized them to one of four virtually-delivered conditions reflecting behavioral economic approaches: episodic future thinking (EFT), volitional choice (VC), both EFT and VC, or enhanced usual care control (EUC). The intervention included a telephone-delivered induction session followed by two weeks of condition-consistent ecological momentary interventions (EMIs; 2x/day) and ecological momentary assessments (EMAs; 1x/day). Participants completed assessments at baseline, post-intervention, and two-month follow-up, and provided intervention feedback. ResultsAll participants completed the telephone-delivered session and elected to receive EMI messages. Average completion rate of EMAs across conditions was 92.9%. Among participants in active intervention conditions, 89.3% reported the induction session was helpful and 80.0% reported it influenced their future drinking. We also report initial alcohol use outcomes. DiscussionThe behavioral economic intervention components and trial procedures evaluated here appear to be feasible and acceptable. Next steps include determination of their efficacy to reduce alcohol use and public health harms.

Developing a narrative communication intervention in the context of HPV vaccination

ObjectiveWe outline the development of a narrative intervention guided by the Common-Sense Model of Self-Regulation (CSM) to promote Human Papillomavirus (HPV) vaccination in a diverse college population. MethodsWe adapted the Obesity-Related Behavioral Intervention Trials (ORBIT) model to guide the development, evaluation, and refinement of a CSM-guided narrative video. First, content experts developed a video script containing information on HPV, HPV vaccines, and HPV-related cancers. The script and video contents were evaluated and refined, in succession, utilizing the think-aloud method, open-ended questions, and a brief survey during one-on-one interviews with university students. ResultsScript and video content analyses led to significant revisions that enhanced quality, informativeness, and relevance to the participants. We highlight the critical issues that were revealed and revised in the iterative process ConclusionsWe developed and refined a CSM guided narrative video for diverse university students. This framework serves as a guide for developing health communication interventions for other populations and health behaviors. InnovationThis project is the first to apply the ORBIT framework to HPV vaccination and describe a process to develop, evaluate, and refine comparable CSM guided narrative interventions that are tailored to specific audiences.

The Application of Cognitive Behavioral Therapy for Adolescent Patients With Endometriosis: A Topical Review

Recent advances and interest in nonpharmacological treatment approaches for various chronic pain conditions in adolescent patients have increased. Cognitive behavioral therapy (CBT) is widely regarded as the leading nonpharmacological treatment for chronic pain, encompassing gynecological conditions associated with chronic pelvic pain, such as endometriosis. Adolescents with endometriosis often present with different symptoms than adults and frequently report more comorbid psychiatric disorders than the general public. This review aims to (1) justify the application of CBT interventions in the context of adolescent patients with endometriosis; (2) integrate and analyze existing empirical evidence and reviews; (3) highlight the advantages, constraints, and future research directions in CBT for this demographic; and (4) introduce a novel biopsychosocial conceptual model. This model intricately considers the interplay of thoughts, emotions, behaviors, and physical symptoms specific to adolescents with endometriosis, providing a foundation for targeted CBT interventions. This holistic approach recognizes the multifaceted nature of their experience, paving the way for comprehensive and effective nonpharmacological therapeutic strategies. Given the nuanced and intricate nature of endometriosis in adolescents, there is a pressing need for innovative conceptual models and clinical trials of behavioral interventions explicitly designed for this demographic.

Pre-exercise protein intake is associated with reduced time in hypoglycaemia among adolescents with type 1 diabetes.

Secondary analyses were conducted from a randomized trial of an adaptive behavioural intervention to assess the relationship between protein intake (g and g/kg) consumed within 4 h before moderate-to-vigorous physical activity (MVPA) bouts and glycaemia during and following MVPA bouts among adolescents with type 1 diabetes (T1D). Adolescents (n = 112) with T1D, 14.5 (13.8, 15.7) years of age and 36.6% overweight/obese, provided measures of glycaemia using continuous glucose monitoring [percentage of time above range (>180 mg/dl), time in range (70-180 mg/dl), time below range (TBR; <70 mg/dl)], self-reported physical activity (previous day physical activity recalls), and 24 h dietary recall data at baseline and 6 months post-intervention. Mixed effects regression models adjusted for design (randomization assignment, study site), demographic, clinical, anthropometric, dietary, physical activity and timing covariates estimated the association between pre-exercise protein intake on percentage of time above range, time in range and TBR during and following MVPA. Pre-exercise protein intakes of 10-19.9 g and >20 g were associated with an absolute reduction of -4.41% (p = .04) and -4.83% (p = .02) TBR during physical activity compared with those who did not consume protein before MVPA. Similarly, relative protein intakes of 0.125-0.249 g/kg and ≥0.25 g/kg were associated with -5.38% (p = .01) and -4.32% (p = .03) absolute reductions in TBR during physical activity. We did not observe a significant association between protein intake and measures of glycaemia following bouts of MVPA. Among adolescents with T1D, a dose of ≥10 g or ≥0.125 g/kg of protein within 4 h before MVPA may promote reduced time in hypoglycaemia during, but not following, physical activity.