Telephone Sessions Research Articles

Self-help guided by trained lay providers for generalized anxiety disorder in older adults: study protocol for a randomized controlled trial

BackgroundOnly a small proportion of older patients with generalized anxiety disorder (GAD) seek professional help. Difficulties in accessing treatment may contribute to this problem. Guided self-help based on the principles of cognitive-behavioral therapy (GSH-CBT) is one way of promoting access to psychological treatment. Moreover, because the therapist’s role in GSH-CBT is limited to supporting the patient, this role could be assumed by trained and supervised lay providers (LPs) instead of licensed providers. The main goal of this study is to evaluate the efficacy of GSH-CBT guided by LPs for primary threshold or subthreshold GAD in older adults.MethodsWe will conduct a multisite randomized controlled trial comparing an experimental group receiving GSH-CBT guided by LPs (n = 45) to a wait-list control group (n = 45). Treatment will last 15 weeks and will be based on a participant’s manual. Weekly telephone sessions with LPs (30 min maximum) will be limited to providing support. Data will be obtained through clinician evaluations and self-assessment questionnaires. Primary outcomes will be the tendency to worry and severity of GAD symptoms. Secondary outcomes will be anxiety symptoms, sleep difficulties, functional deficit, diagnosis of GAD, and cognitive difficulties. For the experimental group, measurements will take place at pre- and post-treatment and at 6 and 12 months post-treatment. For the control group, three evaluations are planned: two pre-treatment evaluations (before and after the waiting period) and after receiving treatment (post-treatment). The efficacy of GSH-CBT will be established by comparing the change in the two groups on the primary outcomes.DiscussionThis project will provide evidence on the efficacy of a novel approach to treat GAD in older adults. If effective, it could be implemented on a larger scale and provide many older adults with much needed mental health treatment through an expanded workforce.Trial registrationThe trial was registered at ClinicalTrials.gov, number NCT03768544, on December 7, 2018.

Telephone-based depression self-management in Hispanic adults with epilepsy: a pilot randomized controlled trial.

Depression is associated with adverse outcomes in epilepsy but is undertreated in this population. Project UPLIFT, a telephone-based depression self-management program, was developed for adults with epilepsy and has been shown to reduce depressive symptoms in English-speaking patients. There remains an unmet need for accessible mental health programs for Hispanic adults with epilepsy. The purpose of this study was to evaluate the feasibility, acceptability, and effects on depressive symptoms of a culturally adapted version of UPLIFT for the Hispanic community. Hispanic patients with elevated depressive symptoms (n = 72) were enrolled from epilepsy clinics in New York City and randomized to UPLIFT or usual care. UPLIFT was delivered in English or Spanish to small groups in eight weekly telephone sessions. Feasibility was assessed by recruitment, retention, and adherence rates and acceptability was assessed by self-reported satisfaction with the intervention. Depressive symptoms (PHQ-9 scores) were compared between study arms over 12 months. The mean age was 43.3±11.3, 71% of participants were female and 67% were primary Spanish speakers. Recruitment (76% consent rate) and retention rates (86–93%) were high. UPLIFT participants completed a median of six out of eight sessions and satisfaction ratings were high, but rates of long-term practice were low. Rates of clinically significant depressive symptoms (PHQ-9 ≥5) were lower in UPLIFT versus usual care throughout follow-up (63% vs. 72%, 8 weeks; 40% vs. 70%, 6 months; 47% vs. 70%, 12 months). Multivariable-adjusted regressions demonstrated statistically significant differences at 6 months (OR = 0.24, 95% CI, 0.06–0.93), which were slightly reduced at 12 months (OR = 0.30, 95% CI, 0.08–1.16). Results suggest that UPLIFT is feasible and acceptable among Hispanic adults with epilepsy and demonstrate promising effects on depressive symptoms. Larger trials in geographically diverse samples are warranted.

Acceptance and commitment therapy for fatigue interference in advanced gastrointestinal cancer and caregiver burden: protocol of a pilot randomized controlled trial

BackgroundFatigue interference with activities, mood, and cognition is one of the most prevalent and bothersome concerns of advanced gastrointestinal (GI) cancer patients. As fatigue interferes with patient functioning, family caregivers often report feeling burdened by increasing responsibilities. Evidence-based interventions jointly addressing cancer patient fatigue interference and caregiver burden are lacking. In pilot studies, acceptance and commitment therapy (ACT) has shown promise for addressing symptom-related suffering in cancer patients. The current pilot trial seeks to test a novel, dyadic ACT intervention for both advanced GI cancer patients with moderate-to-severe fatigue interference and their family caregivers with significant caregiving burden or distress.MethodsA minimum of 40 patient-caregiver dyads will be randomly assigned to either the ACT intervention or an education/support control condition. Dyads in both conditions attend six weekly 50-min telephone sessions. Outcomes are assessed at baseline as well as 2 weeks and 3 months post-intervention. We will evaluate the feasibility, acceptability, and preliminary efficacy of ACT for improving patient fatigue interference and caregiver burden. Secondary outcomes include patient sleep interference and patient and caregiver engagement in daily activities, psychological flexibility, and quality of life. We will also explore the effects of ACT on patient and caregiver physical and mental health service use.DiscussionFindings will inform a large-scale trial of intervention efficacy. Results will also lay the groundwork for further novel applications of ACT to symptom interference with functioning and caregiver burden in advanced cancer.Trial RegistrationClinicalTrials.gov, NCT04010227. Registered 8 July 2019.

Is Anyone There? Use of the Telephone and Use of the Couch

Many therapists have been using the telephone for analytic sessions during the Covid 19 pandemic. This paper considers the ways in which the use of the telephone resembles the use of the couch and revisits the value of the couch in order to assess the value of the telephone. The questions raised are whether analytic therapists still find the use of the couch helpful, and if so why. This is then linked to the experience of using only the telephone. The paper considers the ways in which the two techniques increase or diminish shame and the willingness to disclose difficult material. An anonymized clinical illustration is used of a woman who began in face‐to‐face work with a purely practical problem, but in telephone sessions was able to acknowledge her need to understand her own mental state in order to be able to change at a deeper level. Conclusions are drawn about the positive usefulness of the telephone in contrast with the view that it is just the best that we can do in some circumstances.

SWOG S1820: Altering Intake, Managing Symptoms for bowel dysfunction in survivors of Rectal Cancer (The AIMS-RC intervention trial)

ObjectiveTo describe the study protocol of SWOG S1820, a trial of the Altering Intake, Managing Symptoms intervention for bowel dysfunction in survivors of Rectal Cancer (AIMS-RC). DesignSWOG S1820 is a multi-site, randomized trial of 94 post-treatment survivors of rectal cancer, comparing the intervention and attention control arms. SettingAffiliated institutions of the National Cancer Institute (NCI)-supported National Community Oncology Research Program (NCORP) and the National Clinical Trial Network (NCTN). ParticipantsSurvivors of rectal cancer who are between 6 and 24 months after treatment completion. InterventionAIMS-RC is a 17-week, 10 session telephone coaching program to help survivors of rectal cancer track their symptoms and improve their diets for better health and bowel function. It includes telephone-based coaching, resource manual, and personalized text/email messaging for motivation in between the telephone sessions. Main outcome measuresBowel function, low anterior resection syndrome score, quality of life (QOL), dietary quality, motivation, self-efficacy, positive/negative affect, feasibility, adherence, retention, acceptability. AnalysisThirty-seven participants per arm (74 total) provide 80% power to detect this 0.5 standard deviation effect size, based on a two-sample t-test with a 1-sided alpha = 0.1. A total of 94 randomized participants will be accrued to account for 7% ineligibility and 15% attrition at 6 months.

Collaborative Care Management for Community-Dwelling Older Adults Prescribed Opioids: A Summary of Pilot Program Findings

<h3>Introduction</h3> Pain is highly comorbid with mental health problems, and can lead to significant disability and loss of function. Pain is common among older adults, with approximately half of older adults nationwide reporting experiencing bothersome pain in the preceding month. The treatment of pain in later life is complicated by a variety of factors, and there are significant safety risks associated with the use of analgesics, especially opioids. Multimodal strategies and collaborative care models that employ both non-pharmacological and pharmacological methods of pain care management may be especially promising in treating pain and improving outcomes. The objective of this project was to explore preliminary results from a pilot study of a telephone-delivered collaborative care service designed for community-dwelling older adults with chronic pain receiving prescriptions for high doses of opioids. Specifically, we were interested in examining program feasibility and acceptability, the extent to which engaged patients and their prescribers achieved opioid dose reduction, and changes in patient-level symptoms (e.g., pain severity and interference, depressive symptoms). <h3>Methods</h3> Eligible participants included 82 older adults referred by the Pennsylvania Department of Aging's pharmaceutical assistance program for low-income seniors (PACE/PACENET) to the University of Pennsylvania/PACE Behavioral Health Laboratory program. Referred patients were identified as receiving chronic opioid prescriptions for > 120 mg morphine-equivalent dose (MED) per day. Upon enrollment, patients first completed a comprehensive baseline clinical assessment. Clinical data on mental health, cognition, pain and functional status, as well as self-reported daily opioid dose and biopsychosocial needs, were collected over the phone and entered into the program's informatics tool. Patients next engaged in a series of telephone sessions during which care managers offered individualized treatment planning. Program goals included opioid dose reduction to safer levels and improved pain and psychosocial outcomes. Treatment modalities offered included: (1) behavioral pain management, (2) general medication education, (3) reinforcing positive health behaviors, (4) addressing barriers to change, (5) scheduling positive activities, and (6) relaxation techniques. Following each session, summary reports were sent to prescribers with recommendations for pain care management and opioid dose reduction. <h3>Results</h3> Enrolled patients were on average 73.5 (+/-6.1) years old, and the majority were non-Hispanic white (91%) and female (70%). Seventy-seven percent of the sample met criteria for clinically significant anxiety or depressive symptomatology. Of the 82 patients completing the baseline assessment, 53 (65%) engaged in the program. Patients were considered engaged in the program if they completed the baseline assessment and two or more additional follow-up contacts with a care manager. Those who engaged in the program did not differ on sociodemographic or clinical characteristics or baseline reports of pain when compared to those who did not engage. Pre-post intervention comparisons suggest a significant reduction in medication dose at the last contact relative to baseline. Further, at their last clinical contact, 66% of engaged patients achieved dose reductions of >20%. While there were no significant changes in pain interference or pain-related self-efficacy, engaged patients did report reductions in pain severity (p=0.05) and depressive symptoms (p=0.003) at the last contact relative to baseline. Preliminary findings also suggest that patients who achieved dose reductions of >20%, compared to those who did not, showed greater reductions in depressive symptoms and pain interference at the last contact relative to baseline. Pharmacy record data comparing those who engaged versus those who did not engage in the program were also collected for analysis. <h3>Conclusions</h3> In conclusion, the findings provide preliminary support for the feasibility of a community-based, collaborative care model for pain management and suggest the potential for positive treatment outcomes. The results also support further development and evaluation of collaborative care models that aim to address opioid use in later life. <h3>Funding</h3> Pennsylvania Department of Aging, PACE/PACENET program

Effect of Telephone Cognitive Behavioral Therapy for Insomnia in Older Adults With Osteoarthritis Pain

Scalable delivery models of cognitive behavioral therapy for insomnia (CBT-I), an effective treatment, are needed for widespread implementation, particularly in rural and underserved populations lacking ready access to insomnia treatment. To evaluate the effectiveness of telephone CBT-I vs education-only control (EOC) in older adults with moderate to severe osteoarthritis pain. This is a randomized clinical trial of 327 participants 60 years and older who were recruited statewide through Kaiser Permanente Washington from September 2016 to December 2018. Participants were double screened 3 weeks apart for moderate to severe insomnia and osteoarthritis (OA) pain symptoms. Blinded assessments were conducted at baseline, after 2 months posttreatment, and at 12-month follow-up. Six 20- to 30-minute telephone sessions provided over 8 weeks. Participants submitted daily diaries and received group-specific educational materials. The CBT-I instruction included sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and homework. The EOC group received information about sleep and OA. The primary outcome was score on the Insomnia Severity Index (ISI) at 2 months posttreatment and 12-month follow-up. Secondary outcomes included pain (score on the Brief Pain Inventory-short form), depression (score on the 8-item Patient Health Questionnaire), and fatigue (score on the Flinders Fatigue Scale). Of the 327 participants, the mean (SD) age was 70.2 (6.8) years, and 244 (74.6%) were women. In the 282 participants with follow-up ISI data, the total 2-month posttreatment ISI scores decreased 8.1 points in the CBT-I group and 4.8 points in the EOC group, an adjusted mean between-group difference of -3.5 points (95% CI, -4.4 to -2.6 points; P < .001). Results were sustained at 12-month follow-up (adjusted mean difference, -3.0 points; 95% CI, -4.1 to -2.0 points; P < .001). At 12-month follow-up, 67 of 119 (56.3%) participants receiving CBT-I remained in remission (ISI score, ≤7) compared with 33 of 128 (25.8%) participants receiving EOC. Fatigue was also significantly reduced in the CBT-I group compared with the EOC group at 2 months posttreatment (mean between-group difference, -2.0 points; 95% CI, -3.1 to -0.9 points; P = <.001) and 12-month follow-up (mean between-group difference, -1.8 points; 95% CI, -3.1 to -0.6 points; P = .003). Posttreatment significant differences were observed for pain, but these differences were not sustained at 12-month follow-up. In this randomized clinical trial, telephone CBT-I was effective in improving sleep, fatigue, and, to a lesser degree, pain among older adults with comorbid insomnia and OA pain in a large statewide health plan. Results support provision of telephone CBT-I as an accessible, individualized, effective, and scalable insomnia treatment. Clinical Trials.gov Identifier: NCT02946957.

A non-randomised pilot study of the Solutions for Medication Adherence Problems (S-MAP) intervention in community pharmacies to support older adults adhere to multiple medications

BackgroundOlder patients prescribed multiple medications commonly experience difficulties with adherence. High-quality evidence on interventions targeting older patients is lacking. Theory is rarely used to tailor adherence solutions. This study aimed to pilot test a novel intervention, developed using the Theoretical Domains Framework, which guides community pharmacists in identifying adherence barriers and delivering tailored solutions (behaviour change techniques). Key study procedures (e.g. recruitment, data collection) for a future randomised controlled trial (cRCT) were also assessed.MethodsUsing purposive sampling, this non-randomised pilot study aimed to recruit 12 community pharmacies (six in Northern Ireland; six in London, England). Pharmacists were trained to deliver the intervention to non-adherent older patients (maximum 10 per pharmacy; target n = 60-120) aged ≥ 65 years (reduced to 50 years due to recruitment challenges) and prescribed ≥ 4 regular medicines. The intervention, guided by an iPad web-application, was delivered over 3-4 face-to-face or telephone sessions, tailored to specific barriers to adherence. We assessed the feasibility of collecting adherence data (primary outcome: self-report and dispensing records), health-related quality of life (HRQOL) and unplanned hospitalisations (secondary outcomes) at baseline and 6-months. The final decision on progressing to a cRCT, using pre-defined ‘stop-amend-go’ criteria, is presented.ResultsFifteen pharmacists from 12 pharmacies were recruited and trained. One pharmacy subsequently dropped out. Sixty patients were recruited (meeting the ‘Amend’ progression criteria), with 56 receiving the intervention. Adherence barriers were identified for 55 patients (98%) and a wide range of behaviour change solutions delivered (median: 5 per patient). Self-report and dispensing adherence data were available for 37 (61.7%) and 44 (73.3%) patients, respectively. HRQOL data were available for 35 (58.3%) patients. GP-reported and self-reported hospitalisations data were available for 47 (78.3%) and 23 (38.3%) patients, respectively. All progression concepts were met (nine ‘Go’ and three ‘Amend’ criteria).ConclusionThis study demonstrates the feasibility of key study procedures (e.g. pharmacy recruitment) and delivery of a tailored adherence intervention in community pharmacies. However, modifications are required to enhance issues identified with patient recruitment, retention and missing data. A future definitive cRCT will explore the effectiveness of the intervention.Trial registrationISRCTN, ISRCTN73831533, Registered 12 January 2018.

Patient Satisfaction with and Use of Telemental Health Services in the Perinatal Period: a Survey Study

We aimed to assess patients’ utilization of and satisfaction with telemental health (TMH) in the perinatal period. We hypothesized that satisfaction with TMH would be at least equal to, if not greater than, with in-person appointments. We conducted a cross-sectional survey between March 2018–June 2019 to evaluate patient satisfaction with and use of TMH services in the perinatal period. Participants used TMH services across the second and third trimester of pregnancy and the first year post-partum. Nearly half of the patients (8/19, 42%) used TMH to see their provider within the first two weeks post-partum. Participants were most commonly in treatment for anxiety (14/19, 74%) and/or depression (9/19, 47%). Most participants agreed or strongly agreed (13/19, 69%) that TMH improved their access to healthcare and that they could see the clinician as well as if they met in person (14/19, 74%). TMH was a highly accepted and appreciated method of mental health care delivery for perinatal women when offered as an alternative to in-person or telephone sessions.

Development and Cultural Adaptation of a Computer-Delivered and Multi-Component Alcohol Reduction Intervention for Russian Women Living with HIV and HCV.

Background:There is elevated prevalence of problem drinking among Russian women living with HIV and HCV co-infection. This paper describes the development and cultural adaptation of a multi-component alcohol reduction intervention incorporating a brief, computer-delivered module for Russian women living with HIV and HCV co-infection.Methods:The format and content of the intervention were adapted to be linguistic-, cultural-, and gender-appropriate using the ADAPT-ITT framework. A computer-delivered module and brief clinician-delivered individual and telephone sessions were developed.Results:We describe the theoretical foundations of the intervention, the cultural adaptation of the intervention, and overview the content of the intervention’s multiple components.Discussion:Interventions to reduce alcohol use that can be integrated within Russian HIV treatment centers are urgently needed. If efficacious, the culturally-adapted intervention offers the promise of a cost-effective, easily disseminated intervention approach for Russian women living with HIV/HCV co-infection engaging in problematic alcohol use.

A Pragmatic Randomized Controlled Trial to Increase PrEP Uptake for HIV Prevention: 55-Week Results From PrEPChicago.

We tested preliminary efficacy of a peer change agent type I network intervention to increase pre-exposure prophylaxis (PrEP) linkage to care among network members connected to young Black men who have sex with men. Parent study is a pragmatic randomized controlled trial with 110 weeks of total follow-up. Interim midpoint analyses are performed here using participant data before crossover assignment at 55 weeks. We randomly assigned 423 participants in Chicago to receive the network intervention, an opinion leader workshop with telephonic booster sessions, versus a time-matched control from 2016 to 2018. The consolidated surrogate outcome was PrEP referral and linkage to clinical care among network members connected to study participants and was collected from independent administrative data. Each study participant in the trial (n = 423) had on average 1822 network contacts who could be eligible for PrEP referral and linkage. During the 55-week observation period, PrEP referral was most likely to occur within 3 days of an intervention session compared to control [odds ratio (OR) 0.07 (0.02-0.013); P = 0.007] resulting in 1-2 referrals of network members per session. Network members with referral or linkage were more likely to be connected to study participants in the intervention arm than the control condition [aOR 1.50 (1.09-2.06); P = 0.012]. A peer change agent type I network intervention is preliminarily effective at diffusing PrEP through a network of individuals highly susceptible to HIV over 55 weeks. This low-intensity intervention demonstrated network-level impact among populations that have experienced limited PrEP care engagement in the United States.

Food-specific serum IgG and symptom reduction with a personalized, unrestricted-calorie diet of six weeks in Irritable Bowel Syndrome (IBS)

BackgroundIrritable Bowel Syndrome (IBS) is a widespread disease with variable symptoms that have an important impact on the quality of life. Despite the prevalence of IBS, its etiology and pathophysiology are still to be fully understood, but immune response is known to be involved. In this study, we investigated the variation of two specific cytokines, B-cell activating factor (BAFF) and platelet-activating factor (PAF), the levels of food-specific IgG and the symptom severity, using Irritable Bowel Syndrome—Symptom Severity Score (IBS-SSS), following a personalized and unrestricted-calorie diet.MethodsWe enrolled 30 subjects with diagnosis of IBS, according to Rome-IV criteria, whose inflammatory markers were measured at baseline and after 6 weeks of dietary intervention. The subjects were monitored in a general practice outpatient setting and nutritional advice was offered remotely via two telephone sessions with a nutritionist.ResultsBAFF and PAF values did not differ between baseline and end of study, both in compliant (C) and non-compliant (NC) subjects. IgG levels significantly decreased only in compliant subjects: 37.32 (23.24–93.67) IU/mL; 27.9 (7.56–93.96) IU/mL (p = 0.02) and in non-compliant went from 51.83 (13.17–113.1) IU/mL to 44.06 (4.96–255.4) IU/mL (p = 0.97, ns). IBS-SSS significantly decreased in both compliant subjects, from 245 (110–480) to 110 (0–140) (p < 0.0001), and non compliant subjects, from 250 (155–370) to 100 (7–220) (p < 0.0001). Comparing IBS-SSS between week 3 and week 6, only compliant subjects had a significant reduction, from 155 (50–355) to 110 (0–140) (p = 0.005), versus non-compliant, from 115 (35–315) to 100 (7–220) (p = 0.33, ns).ConclusionThese findings support the rapid efficacy and suitability of a personalized dietetic intervention with outside consultation in IBS.Trial registration: ClinicalTrials.gov ID NCT04348760 Registered April 15, 2020 (retrospectively registered) https://clinicaltrials.gov/show/NCT04348760

A physical activity coaching intervention can improve and maintain physical activity and health-related outcomes in adult ambulatory hospital patients: the Healthy4U-2 randomised controlled trial

BackgroundThe Healthy 4 U-2 study sought to evaluate the effect of a twelve-week, physical activity (PA) coaching intervention for changes and maintenance in PA, anthropometrics and health-related outcomes in adults presenting to an ambulatory hospital clinic.MethodsOne hundred and twenty insufficiently active adults were recruited from an ambulatory hospital clinic and randomised to an intervention group that received an education session and five 20-min telephone sessions of PA coaching, or to a control group that received the education session only. ActiGraph GT3X accelerometers were used to measure moderate-to-vigorous physical activity (MVPA) at baseline, post-intervention (3-months) and follow-up (9-months). Secondary outcome measures (anthropometrics, PA self-efficacy, and health-related quality of life) were also assessed at the three time points.ResultsAt baseline, the mean age and body mass index of participants were 53 ± 8 years and 31 ± 4 kg/m2, respectively. Relative to control, the intervention group increased objectively measured MVPA at post-intervention (p < 0.001) and 9 months follow-up (p < 0.001). At the 9-month follow-up the intervention group completed 22 min/day of MVPA (95% CI: 20 to 25 min/day), which is sufficient to meet the recommended PA guidelines. The intervention group exhibited beneficial changes in body mass (p < 0.001), waist circumference (p < 0.001), body mass index (p < 0.001), PA self-efficacy (p < 0.001), and health-related quality of life (p < 0.001) at the 9-month follow-up.ConclusionsThis study demonstrates that a low contact PA coaching intervention results in beneficial changes in PA, anthropometrics and health-related outcomes in insufficiently active adults presenting to an ambulatory care clinic. The significant beneficial changes were measured at post-intervention and the 9-month follow-up, demonstrating a maintenance effect of the intervention.Trial registrationProspectively registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR, Trial registration number: ACTRN12619000036112.

Group Lifestyle Balance Adapted for Individuals With Impaired Mobility: Outcomes for 6-Month RCT and Combined Groups at 12 Months

This study examines the feasibility and effectiveness of an intensive lifestyle intervention adapted for people with impaired mobility. This was a randomized, wait-list controlled trial. The experimental group immediately received the 12-month weight loss program; the wait-list control group received it after a 6-month delay. Between-group comparisons were conducted for the 6-month RCT study design. Repeated measures were conducted for both groups combined after receiving the 12-month intervention. Data were collected August 2015-February 2017 and analyzed in 2017. A community-based sample received 23, group-based sessions via a mix of telephone and in-person sessions in a hospital-based setting. Participants with impaired mobility (n=66) were middle-aged (49.80 [SD=11.37] years), mostly White (66.7%), female (66.7%), and most commonly had spinal cord injury (47.0%). The 12-month intervention delivered 23 group-based sessions that promoted weight loss through reducing caloric intake and increasing physical activity. Primary outcomes were effectiveness measured as change in weight and time spent in moderate physical activity. Feasibility was assessed in 12-month combined group analyses, measured as retention, attendance, and dietary self-monitoring. The 6-month RCT results showed that the immediate and delayed groups differed significantly (p<0.05) in weight (-1.66 [SD=4.42] kg loss vs 0.05 [SD=4.15] kg gain) and moderate physical activity (52.93 [SD=90.74] minutes/week increase vs -14.22 [SD=96.02] minutes/week decrease), accounting for baseline weight, time with disability, and age of onset. The 12-month results with groups combined demonstrated 74.2% retention and 77.7% core session attendance. Self-monitoring was higher in the delayed group (77.3%), who used a smartphone app, than the immediate group (47.3%), who mostly used paper trackers. Participants achieved significant 12-month weight loss of 3.31 (SD=10.13) kg (d=0.33) in mixed modeling analyses with groups combined yet did not significantly increase moderate physical activity. Group Lifestyle Balance Adapted for Individuals with Impaired Mobility is a feasible, effective approach to teach healthy lifestyle skills to individuals with mobility impairment, yielding modest weight loss and enhanced self-efficacy. This study is registered at www.clinicaltrials.gov NCT03307187.

Comparison of cognitive-behavioral therapy and yoga for the treatment of late-life worry: A randomized preference trial.

The purpose of this study was to compare the effects of cognitive-behavioral therapy (CBT) and yoga on late-life worry, anxiety, and sleep; and examine preference and selection effects on these outcomes. A randomized preference trial of CBT and yoga was conducted in community-dwelling adults 60 years or older, who scored 26 or above on the Penn State Worry Questionnaire-Abbreviated (PSWQ-A). CBT consisted of 10 weekly telephone sessions. Yoga consisted of 20 biweekly group yoga classes. The primary outcome was worry (PSWQ-A); the secondary outcomes were anxiety (PROMIS-Anxiety) and sleep (Insomnia Severity Index [ISI]). We examined both preference effects (average effect for those who received their preferred intervention [regardless of whether it was CBT or yoga] minus the average for those who did not receive their preferred intervention [regardless of the intervention])and selection effect (which addresses the question of whether there is a benefit to getting to select one intervention over the other, and measures the effect on outcomes of self-selection to a specific intervention). Five hundred older adults were randomized to the randomized trial (125 each in CBT and yoga) or the preference trial (120 chose CBT; 130 chose yoga). In the randomized trial, the intervention effect of yoga compared with CBT adjusted for baseline psychotropic medication use, gender, and race was 1.6 (-0.2, 3.3), p = .08 for the PSWQ-A. Similar results were observed with PROMIS-Anxiety (adjusted intervention effect: 0.3 [-1.5, 2.2], p = .71). Participants randomized to CBT experienced a greater reduction in the ISI compared with yoga (adjusted intervention effect: 2.4 [1.2, 3.7], p < .01]). Estimated in the combined data set (N = 500), the preference and selection effects were not significant for the PSWQ-A, PROMIS-Anxiety, and ISI. Of the 52 adverse events, only two were possibly related to the intervention. None of the 26 serious adverse events were related to the study interventions. CBT and yoga were both effective at reducing late-life worry and anxiety. However, a greater impact was seen for CBT compared with yoga for improving sleep. Neither preference nor selection effects was found.

Protocol of a randomized trial of acceptance and commitment therapy for fatigue interference in metastatic breast cancer

Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns of metastatic breast cancer patients. To date, there are no evidence-based interventions for reducing fatigue interference in metastatic breast cancer and other advanced cancer populations. In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients. The current Phase II trial seeks to more definitively examine the efficacy of telephone-based ACT for women with metastatic breast cancer who are experiencing fatigue interference. In this trial, 250 women are randomly assigned to either the ACT intervention or an education/support control condition. Women in both conditions attend six weekly 50-min telephone sessions. The primary aim of this study is to test the effect of telephone-based ACT on fatigue interference. Secondary outcomes include sleep interference, engagement in daily activities, and quality of life. Outcomes are assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post-intervention. This trial also examines whether increases in psychological flexibility, defined as full awareness of the present moment while persisting in behaviors aligned with personal values, account for the beneficial effect of ACT on fatigue interference. After demonstrating ACT's efficacy, the intervention can be widely disseminated to clinicians who care for metastatic breast cancer patients. Our findings will also inform future ACT trials with various cancer populations and functional outcomes.

Brief behavioral treatment for insomnia improves psychosocial functioning in veterans: results from a randomized controlled trial.

Our goal was to compare brief behavioral treatment for insomnia (BBTI) to a progressive muscle relaxation training (PMRT) control condition among veterans with insomnia, examining psychosocial functioning as a primary outcome and sleep-related outcomes, mood, cognition, and pain as secondary outcomes. Veterans were randomly assigned to either BBTI or PMRT (N = 91; 24-74 years; M = 49 years). BBTI consisted of two in-person (60-min and 30-min sessions) and two telephone sessions (20-min each), and the PMRT control condition was matched to BBTI for session duration and type. Veterans were assessed through clinical interview at baseline and self-report measures at pre-, mid-, and posttreatment, as well as 6-month follow-up for the BBTI condition to assess sustained response. Measures also included continuous sleep monitoring with sleep diary. Intent-to-treat analyses demonstrated that individuals who completed BBTI versus PMRT reported greater improvements in work, home, social and cognitive functioning, insomnia symptom severity, mood, and energy. Improvements in psychosocial functioning, insomnia symptoms, and mood were maintained 6-months following BBTI treatment completion. Veterans who received BBTI improved and maintained gains in psychosocial functioning, insomnia, and mood. BBTI is a treatment that can be implemented in primary care, mental health, or integrated care settings and provide symptom relief and improved functioning among those with insomnia, one of the most commonly reported mental health problems among veterans. NCT02571452.

A novel personalized approach to cardiovascular prevention: The VIVOPTIM programme

Cardiovascular diseases are a leading cause of mortality, but a substantial proportion are preventable. The Mutuelle générale de l'éducation nationale (MGEN), a provider of private health insurance in France, has developed the VIVOPTIM programme, a novel digital approach to healthcare based on individualized, multiprofessional, ranked management of cardiovascular risk factors. Between November 2015 and June 2016, eligible individuals (age 30-70 years) from two regions of France were invited to participate. Volunteers completed a questionnaire based on the Framingham Heart Study Risk Score and were assigned to one of three cardiovascular risk levels. VIVOPTIM comprises four components: cardiovascular risk assessment, instruction on cardiovascular diseases and associated risk factors, personalized coaching (telephone sessions with a specially trained healthcare professional to provide information on risk factors and disease management, set individual health targets, monitor progress and motivate participants), and e-Health monitoring. Data from 2240 participants were analysed. Significant benefits were observed on mean systolic blood pressure (-3.4mmHg), weight (-1.5kg), smoking (-2.2 cigarettes/day) and daily steps (+1726 steps/day (all P<0.0001)), though not on weekly duration of exercise (-0.2hours/week, P=0.619). As a result of the positive mid-to-long-term results of the pilot programme on weight, smoking, blood pressure, and uptake of physical activity, the VIVOPTIM programme was extend to the whole of France in 2018 and has the potential to have a genuine impact on patient care and organization of the healthcare system in France.

A nurse- and peer-led psycho-educational intervention to support women with gynaecological cancers receiving curative radiotherapy: The PeNTAGOn randomised controlled trial – ANZGOG 1102

ObjectiveRadiotherapy for gynaecological cancer is associated with multiple adverse effects. This randomised controlled trial evaluated the impact of a combined nurse- and peer-led psycho-educational intervention on psychological distress, preparation for treatment, quality of life, psychosexual function, unmet needs and vaginal stenosis. MethodsEligible women had a confirmed diagnosis of gynaecological cancer, scheduled to receive radiotherapy with curative intent, aged ≥18 years, and able to read and write English. Participants randomly assigned one-to-one to either four nurse-led consultations plus four peer-led telephone sessions, or to usual care. Participants completed study measures at baseline, immediately before first radiotherapy (FU1), and four weeks (FU2), three (FU3), six (FU4), and 12 months (FU5) post radiotherapy. The primary outcomes were psychological distress at FU1 and FU2 measured by the Hospital Anxiety and Depression Scale. ResultsOf 840 eligible participants, 625 were approached and 319 (51%) consented; 158 assigned to intervention, 160 to usual care with 1 withdrawing before randomisation. Between-groups differences for primary outcomes were trivial- and small-sized, (both p > 0.05). Notable effects on secondary outcomes favouring the intervention at FU2 included preparation for treatment (sensory/psychological concerns, d = 0.57; and procedural concerns, d = 0.52) and specific needs domains (sexuality needs, d = 0.38; and health system and information needs, d = 0.41). ConclusionsThere was no evidence that a nurse- and peer-led intervention had a beneficial effect on psychological distress compared to usual care. However, improved treatment readiness and lower health system and sexuality needs indicate the intervention may have addressed outcomes known to be important to this population.

Effect of 2 Integrated Interventions on Alcohol Abstinence and Viral Suppression Among Vietnamese Adults With Hazardous Alcohol Use and HIV

Hazardous and heavy alcohol use is common among people living with HIV and may decrease antiretroviral therapy (ART) adherence, but limited data exist from randomized clinical trials about the effects of interventions on viral load. To compare the efficacy of 2 scalable ART clinic-based interventions on alcohol use and viral suppression. This 3-group randomized clinical trial was conducted among 440 adults with HIV who were being treated at 7 ART clinics in Thai Nguyen, Vietnam. Adults receiving ART with hazardous alcohol use (Alcohol Use Disorders Identification Test-Consumption score ≥4 for men or ≥3 for women) and no plans to leave Thai Nguyen were included. Data were collected from March 2016 to May 2018 and analyzed from June 2018 to February 2020. Participants were randomly assigned (1:1:1) to standard of care (SOC), a combined intervention of motivational enhancement therapy and cognitive behavioral therapy (6 in-person sessions of 1 hour each and 3 optional group sessions), or a brief intervention with similar components as the combined intervention but consisting of 2 shorter in-person sessions and 2 telephone sessions. The primary study outcomes were percentage of days abstinent from alcohol, confirmed using the alcohol biomarker phosphatidylethanol, and viral suppression at 12 months after enrollment. A total of 440 eligible individuals (mean [SD] age, 40.2 [5.8] years; 426 [96.8%] men) were enrolled; 147 (33.4%) were assigned to the combined intervention, 147 (33.4%) to the brief intervention, and 146 (33.2%) to SOC. In the combined intervention group, 112 participants (76.2%) attended all 6 sessions, and in the brief intervention group, 124 (84.4%) attended all 4 sessions; in the whole sample, 390 (88.6%) completed 12 months of follow-up. At 12 months, the mean (SE) percentage of days abstinent was 65% (3.1%) among those in the combined intervention group, 65% (3.2%) among those in the brief intervention group, and 50% (3.4%) among those in the in the SOC group (Cohen d for combined intervention vs SOC and brief intervention vs SOC: 39%; 95% CI, 15% to 64%). Viral suppression (ie, <20 copies of HIV-1 RNA per milliliter) at 12 months was higher after the brief intervention than SOC (difference, 11%; 95% CI, 2% to 20%), but the difference between the combined intervention and SOC was not significantly different (difference, 5%; 95%, CI, -5% to 15%). In this study, the brief intervention resulted in a significant increase in percentage of days abstinent from alcohol and a significant increase in viral suppression after 12 months. Future implementation science studies evaluating scale-up of the brief intervention are needed. ClinicalTrials.gov Identifier: NCT02720237.