Cultural and linguistic adaptation of a telephone-based cognitive-behavioral therapy (CBT) intervention to treat depression and anxiety in Hispanic cancer survivors.

PURPOSE/OBJECTIVES: The purpose of this study was to transcreate a manualized cognitive-behavioral therapy (CBT) intervention to address depression and anxiety among Hispanic cancer survivors. DESIGN/RESEARCH APPROACH: Stakeholders reviewed the CBT workbook for language, content, and cultural relevance. We designed semi-structured interview guides to elicit intervention feedback. SAMPLE/PARTICIPANTS: Stakeholder participants were Hispanic cancer survivors (n = 4), bilingual mental health providers (n = 2), and oncology professionals (n = 4). METHODS: Transcreation was conducted by initial translation of the workbook followed by incorporation of stakeholder feedback. A bilingual (Spanish and English) interviewer conducted stakeholder interviews. The study team discussed themes/suggestions before refining the workbook. FINDINGS: Stakeholders reported enthusiasm for the intervention. We gathered significant feedback regarding wording, images, and resources for the workbook. CONCLUSION: Development of culturally appropriate mental health resources for Hispanic cancer survivors is critical. IMPLICATIONS FOR PSYCHOSOCIAL PROVIDERS OR POLICY: By broadening research on psychosocial care to the Hispanic population, we increase the reach of evidence-based psychological care. Future research should fully evaluate the adapted CBT intervention among Hispanic survivors.

The relationship between optimism, MCI, and dementia among postmenopausal women.

OBJECTIVES: The relationship between optimism and cognitive functioning is not fully understood. We examined the association of optimism with risk of mild cognitive impairment (MCI) and dementia in the Women's Health Initiative Memory Study (WHIMS). METHODS: Optimism was measured by the Life Orientation Test-Revised (LOT-R) total score, and optimism and pessimism subscales. A panel of experts adjudicated cognitive endpoints based on annual cognitive assessments. We used cox proportional hazard regression models to examine the association of LOT-R total score and optimism and pessimism sub-scores with MCI/dementia. We also examined the relationship between vascular disease, LOT-R total score, optimism and pessimism, and cognition. RESULTS: Mean age was 70.5 (SD = 3.9) years. The sample (N = 7249) was 87% white, and 29.8% of participants had < 12 years of education. Total LOT-R score (HR = 0.96, 95% CI: 0.94, 0.98, p < 0.001) was associated with lower risk of combined MCI or dementia. More pessimism (HR = 1.08, 95% CI: 1.05, 1.11, p < 0.0001) was associated with higher risk of MCI or dementia after adjustment for ethnicity, education, vascular disease, and depression. No significant relationships emerged from the optimism subscale. CONCLUSION: These data suggest that less pessimism, but not more optimism, was associated with a lower risk of MCI and dementia.

Long-Term Effects of Cognitive-Behavioral Therapy and Yoga for Worried Older Adults.

OBJECTIVES: Cognitive-behavioral therapy (CBT) and yoga decrease worry and anxiety. There are no long-term data comparing CBT and yoga for worry, anxiety, and sleep in older adults. The impact of preference and selection on these outcomes is unknown. In this secondary data analysis, we compared long-term effects of CBT by telephone and yoga on worry, anxiety, sleep, depressive symptoms, fatigue, physical function, social participation, and pain; and examined preference and selection effects. DESIGN: In this randomized preference trial, participants (N = 500) were randomized to a: 1) randomized controlled trial (RCT) of CBT or yoga (n = 250); or 2) preference trial (selected CBT or yoga; n = 250). Outcomes were measured at baseline and Week 37. SETTING: Community. PARTICIPANTS: Community-dwelling older adults (age 60+ years). INTERVENTIONS: CBT (by telephone) and yoga (in-person group classes). MEASUREMENTS: Penn State Worry Questionnaire - Abbreviated (worry);1,2 Insomnia Severity Index (sleep);3 PROMIS Anxiety Short Form v1.0 (anxiety);4,5 Generalized Anxiety Disorder Screener (generalized anxiety);6,7 and PROMIS-29 (depression, fatigue, physical function, social participation, pain).8,9 RESULTS: Six months after intervention completion, CBT and yoga RCT participants reported sustained improvements from baseline in worry, anxiety, sleep, depressive symptoms, fatigue, and social participation (no significant between-group differences). Using data combined from the randomized and preference trials, there were no significant preference or selection effects. Long-term intervention effects were observed at clinically meaningful levels for most of the study outcomes. CONCLUSIONS: CBT and yoga both demonstrated maintained improvements from baseline on multiple outcomes six months after intervention completion in a large sample of older adults. TRIAL REGISTRATION: www. CLINICALTRIALS: gov Identifier NCT02968238.

Evidence-based assessment of treatment outcomes for late-life generalized anxiety disorder using the Penn State Worry Questionnaire (PSWQ) and Penn State Worry Questionnaire - Abbreviated (PSWQ-A).

OBJECTIVE: The Penn State Worry Questionnaire (PSWQ) is a commonly used measure of treatment outcome for late-life generalized anxiety disorder (GAD). However, there is considerable variability in the definitions used to define treatment response and remission. This study aimed to provide empirically derived guidelines for assessing treatment response and remission among older adults with GAD using the PSWQ and the abbreviated PSWQ (PSWQ-A). DESIGN: Longitudinal assessment of GAD symptoms pre- and posttreatment. PARTICIPANTS: Participants were 259 older adults aged 60-86 years with a diagnosis of GAD who were assessed before and after treatment. INTERVENTION: Participants were randomly assigned to cognitive behavioral therapy or control (waitlist, discussion group, or supportive therapy) conditions. MEASUREMENTS: Signal-detection analyses using receiver operating characteristic (ROC) methods were used to determine optimal agreement between structured diagnostic interviews and scores on the PSWQ and PSWQ-A. RESULTS: Results suggest that a score of ≤51 was optimal for defining diagnostic remission status on the PSWQ, and a score of ≤24 was optimal on the PSWQ-A. A 9% reduction or ≥4-point reduction was optimal for assessing treatment response on the PSWQ. The PSWQ-A was poor at identifying treatment response status. CONCLUSIONS: Findings suggest that most of the previously used definitions have underestimated the treatment effects for late-life GAD. However overall, the PSWQ and PSWQ-A are suboptimal for assessing treatment outcome for late-life GAD. The standardization of response and remission criteria has implications for comparison between treatment trials, and for the benchmarking of outcomes in clinical practice.

Cognition, Physical Function, and Quality of Life in Older Patients With Acute Decompensated Heart Failure.

BACKGROUND: Older adults with acute decompensated heart failure have persistently poor clinical outcomes. Cognitive impairment (CI) may be a contributing factor. However, the prevalence of CI and the relationship of cognition with other patient-centered factors such a physical function and quality of life (QOL) that also may contribute to poor outcomes are incompletely understood. METHODS AND RESULTS: Older (≥60 years) hospitalized patients with acute decompensated heart failure were assessed for cognition (Montreal Cognitive Assessment [MoCA]), physical function (Short Physical Performance Battery [SPPB], 6-minute walk distance [6MWD]), and QOL (Kansas City Cardiomyopathy Questionnaire, Short Form-12). Among patients (N = 198, 72.1 ± 7.6 years), 78% screened positive for CI (MoCA of <26) despite rare medical record documentation (2%). Participants also had severely diminished physical function (SPPB 6.0 ± 2.5 units, 6MWD 186 ± 100 m) and QOL (scores of <50). MoCA positively related to SPPB (ß = 0.47, P < .001), 6MWD ß = 0.01, P = .006) and inversely related to Kansas City Cardiomyopathy Questionnaire Overall Score (ß = -0.05, P < .002) and Short Form-12 Physical Component Score (ß = -0.09, P = .006). MoCA was a small but significant predictor of the results on the SPPB, 6MWD, and Kansas City Cardiomyopathy Questionnaire. CONCLUSIONS: Among older hospitalized patients with acute decompensated heart failure, CI is highly prevalent, is underrecognized clinically, and is associated with severe physical dysfunction and poor QOL. Formal screening may reduce adverse events by identifying patients who may require more tailored care.

Examining brief and ultra-brief anxiety and depression screening methods in a real-world epilepsy clinic sample.

OBJECTIVE: Recent epilepsy quality measure recommendations for depression and anxiety screening endorse ultra-brief screeners, the Patient Health Questionnaire-2 (PHQ-2) and Generalized Anxiety Disorder-2 (GAD-2). Thus, it is important to assess how symptom detection may be affected using ultra-brief screeners compared with slightly longer, well-validated instruments: Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) and Generalized Anxiety Disorder-7 (GAD-7). The objective was to compare symptom detection by brief versus ultra-brief depression and anxiety screeners in a large real-world epilepsy clinic sample. METHODS: This was a prospective, cross-sectional assessment of consecutive patients in an adult tertiary epilepsy practice who completed the GAD-7 and NDDI-E with embedded ultra-brief scales (GAD-2; GAD-Single Item: GAD-SI; NDDI-E 2 item: NDDIE-2) on a tablet and had clinic staff administered ultra-brief PHQ-2 (yes/no version) documented in the medical record at the same visit. Prevalences of positive anxiety and depression screens were calculated for each instrument overall, and by epilepsy status. Concordance correlation coefficients (CCC) were calculated comparing the ultra-brief with brief anxiety and depression instruments, and receiver operating curves (ROC) were calculated using the longer instruments as alternative standards. RESULTS: Among N = 422 individuals the prevalence of positive anxiety screen by GAD-7 was 24% and positive depression screen by NDDI-E was 20%. Positive anxiety and depression screens were significantly less prevalent among seizure-free individuals than those with continued seizures. The verbally administered yes/no PHQ-2 had only 1 positive screen (0.2%). Other than poor concordance between the PHQ-2 and NDDI-E, the screener pairs had acceptable concordance (CCC 0.79 to 0.92). Areas under the ROC curves were acceptable for the NDDIE-2, GAD-2 and GAD-SI (0.96, 0.98, and 0.89, respectively). SIGNIFICANCE: In this sample, clinic staff interview-administered yes/no PHQ-2 had exceedingly low sensitivity compared with the NDDI-E self-reported on a tablet. Further investigation is warranted to assess if poor detection is due to characteristics of this PHQ-2 in epilepsy samples, or method of administration in this clinic. The other ultra-brief anxiety and depression instruments demonstrated good concordance with the longer, well-validated instruments and may be useful in clinical practice.

Neurologist prescribing versus psychiatry referral: Examining patient preferences for anxiety and depression management in a symptomatic epilepsy clinic sample.

OBJECTIVE: Anxiety and depression symptoms in epilepsy are common, impactful and under-recognized and undertreated. While prior survey data suggests equipoise among epileptologists for managing anxiety and/or depression via prescribing in the epilepsy clinic versus psychiatry referral, patient preferences are unknown and should potentially influence practice habits among epileptologists. Thus, the primary objective of this study was to determine patient preference for anxiety and/or depression prescribing by neurologists versus psychiatry referral among an adult epilepsy clinic sample of symptomatic patients. METHODS: Management preferences for anxiety and/or depression were surveyed in an adult tertiary care epilepsy clinic. Individuals who screened positive for anxiety and/or depression symptoms on validated instruments during a routine care-embedded learning health system study were recruited. Demographics, social variables, psychiatric treatment history, and treatment priorities and preferences were surveyed. Preference was defined as a slightly greater than 2:1 ratio in favor neurology prescribing or psychiatry referral. The study was powered to assess this primary objective using a two-sample binomial test. Multinomial logistic regression examined an a priori multivariable model of treatment preference (secondary objective). RESULTS: The study sample included N = 63 symptomatic adults, with 64% women and mean age 42.2 years. Most reported past or current treatment for anxiety and/or depression, and treatment for these symptoms was a high or moderate priority among 65.1% of the sample. Neurologist prescribing was preferred in 83.0% (nearly 5:1) over psychiatry referral among those who chose neurology or psychiatry (as opposed to neither of the two; p < 0.001, 95% CI 0.702-0.919). Overall, 69.8% of the total study sample preferred neurology prescribing. Multivariable modeling indicated preference for neither management option (compared with neurologist prescribing) was associated with low overall treatment prioritization and having never received neurologist medication management. None of the factors examined in the a priori multivariable model were associated with selecting psychiatry referral (compared to neurologist prescribing). CONCLUSION: In this sample, most patients indicated a preference for neurologists to prescribe for anxiety or depression symptoms in the epilepsy clinic. Care models involving neurologist prescribing for anxiety and depression symptoms merit further investigation and potential adoption in clinical practice.

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

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

The Effects of Yoga on Patients with Mild Cognitive Impairment and Dementia: A Scoping Review.

Yoga is an ancient mind body practice. Although yoga has been used as a complementary health approach for enhancing wellness and addressing a variety of health issues, little is known about the impact of yoga on cognitive functioning in adults with mild cognitive impairment (MCI) and dementia. We conducted a literature review to examine the impact of yoga on persons with MCI and dementia. Eight studies were identified that reported on yoga as either the primary intervention or one component of a multi-component intervention in samples of persons with MCI or dementia. Results suggest that yoga may have beneficial effects on cognitive functioning, particularly on attention and verbal memory. Further, yoga may affect cognitive functioning through improved sleep, mood, and neural connectivity. There are a number of limitations of the existing studies, including a lack of intervention details, as well as variability in the frequency/duration and components of the yoga interventions. A further complicating issue is the role of various underlying etiologies of cognitive impairment. Despite these limitations, providers may consider recommending yoga to persons with MCI or dementia as a safe and potentially beneficial complementary health approach.

Long-Term Effects of Telephone-Delivered Psychotherapy for Late-Life GAD.

OBJECTIVE: To examine the long-term effects of telephone-delivered cognitive-behavioral therapy (CBT-T) compared with nondirective supportive therapy (NST-T) in rural older adults with generalized anxiety disorder (GAD). METHODS: 141 adults aged 60 years and older with a principal/co-principal diagnosis of GAD were randomized to either CBT-T or NST-T. CBT-T consisted of up to 11 sessions (9 were required) focused on recognition of anxiety symptoms, relaxation, cognitive restructuring and use of coping statements, problem-solving, worry control, behavioral activation, exposure therapy, and relapse prevention, with optional chapters on sleep and pain. NST-T consisted of 10 sessions focused on providing a supportive atmosphere in which participants could share and discuss their feelings and did not provide any direct suggestions. Primary outcomes included interviewer-rated anxiety severity and self-report worry severity measured at 9 months and 15 months after randomization. Mood-specific secondary outcomes included self-report GAD symptoms and depressive symptoms. RESULTS: At 15 months, after adjustment for multiple testing, there was a significantly greater decline in general anxiety symptoms (difference in improvement: 3.31; 95% CI: 0.45-6.17; t = 2.29; df = 136; p = 0.024) and worry (difference in improvement: 3.13; 95% CI: 0.59-5.68; t = 2.43; df = 136; p = 0.016) among participants in CBT-T compared with those in the NST-T group. There were no significant differences between the conditions in terms of depressive symptoms (difference in improvement: 2.88; 95% CI: 0.17-5.60; t = 2.10; df = 136; p = 0.0376) and GAD symptoms (difference in improvement: 1.65; 95% CI: -0.20 to 3.50; t = 1.76; df = 136; p = 0.080). CONCLUSIONS: CBT-T is superior to NST-T in reducing worry and anxiety symptoms 1 year after completing treatment.

Effects of Telephone-Delivered Cognitive-Behavioral Therapy and Nondirective Supportive Therapy on Sleep, Health-Related Quality of Life, and Disability.

OBJECTIVES: The purpose of this study was to compare the effects of cognitive-behavioral therapy delivered by telephone (CBT-T) and telephone-delivered nondirective supportive therapy (NST-T) on sleep, health-related quality of life, and physical disability in rural older adults with generalized anxiety disorder. METHODS: This was a secondary analysis of a randomized clinical trial on 141 rural-dwelling adults 60 years and older diagnosed with generalized anxiety disorder. Sleep was assessed with the Insomnia Severity Index. Health-related quality of life was assessed with the 36-item Short-Form Health Survey (SF-36). Physical disability was assessed with the Pepper Center Tool for Disability. Assessments occurred at baseline, 4 months, 9 months, and 15 months. RESULTS: Insomnia declined in both groups from baseline to 4 months, with a significantly greater improvement among participants who received CBT-T. Similarly, Mental and Physical Component Summaries of the SF-36 declined in both groups, with a differential effect favoring CBT-T. Participants in both interventions reported declines in physical disability, although there were no significant differences between the two interventions. Improvements in insomnia were maintained at the 15-month assessment, whereas between-group differences shrank on the Mental and Physical Component Summaries of the SF-36 by the 15-month assessment. CONCLUSION: CBT-T was superior to NST-T in reducing insomnia and improving health-related quality of life. The effects of CBT-T on sleep were maintained 1 year after completing the treatment.

Barriers to Mental Health Treatment in Rural Older Adults.

OBJECTIVES: The purpose of this study was to identify the barriers to seeking mental health treatment experienced by rural older adults. We also examined if barriers differed by age and worry severity. METHODS: Participants were 478 rural older adults responding to a flyer for a psychotherapy intervention study. Interested participants were screened by telephone, and barriers to mental health treatment were assessed. Participants completed a demographic questionnaire and the Penn State Worry Questionnaire-Abbreviated. RESULTS: The most commonly reported barrier to treatment was the personal belief that "I should not need help." Other commonly reported barriers included practical barriers (cost, not knowing where to go, distance), mistrust of mental health providers, not thinking treatment would help, stigma, and not wanting to talk with a stranger about private matters. Multivariable analyses indicated that worry severity and younger age were associated with reporting more barriers. CONCLUSIONS: Multiple barriers interfere with older adults seeking treatment for anxiety and depression. Older age is associated with fewer barriers, suggesting that the oldest old may have found strategies for overcoming these barriers. Young-old adults may benefit from interventions addressing personal beliefs about mental health and alternative methods of service delivery.

Telephone-delivered psychotherapy for rural-dwelling older adults with generalized anxiety disorder: study protocol of a randomized controlled trial.

BACKGROUND: Generalized Anxiety Disorder (GAD), characterized by excessive and uncontrollable worry, has a negative impact on the health, well-being, and functioning of older adults. Cognitive behavioral therapy has demonstrated efficacy in reducing anxiety and worry in older adults, but the generalizability of these findings to community-dwelling older adults is unknown. The aim of the current study is to examine the efficacy of a cognitive-behavioral intervention delivered by telephone in reducing anxiety and worry in rural community-dwelling older adults with GAD. METHODS/DESIGN: We propose a randomized controlled trial comparing telephone-delivered cognitive behavioral therapy (CBT-T) with nondirective supportive therapy (NST-T). One hundred seventy six adults 60 years and older diagnosed with GAD will be randomized to one of the two treatment conditions. The primary outcomes are self-report worry and clinician-rated anxiety. Secondary outcomes include depressive symptoms, sleep, quality of life, and functional status. DISCUSSION: It is hypothesized that CBT-T will be superior to NST-T in reducing anxiety and worry among older adults with GAD. Further, CBT-T is hypothesized to be superior to NST-T in reducing problems with depressive symptoms, sleep, functional status and quality of life. If this program is successful, it could be implemented as a low-cost program to treat late-life anxiety, especially in rural areas or in circumstances where older adults may not have access to qualified mental health providers. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01259596.

Quality of life during usual epilepsy care for anxiety or depression symptoms: Secondary patient-reported outcomes in a randomized trial of remote assessment methods.

BACKGROUND AND OBJECTIVES: Anxiety and depression are highly prevalent and impactful in epilepsy. American Academy of Neurology quality measures emphasize anxiety and depression screening and quality of life (QOL) measurement, yet usual epilepsy care QOL and anxiety/depression outcomes are poorly characterized. The main objective was to assess 6-month QOL, anxiety and depression during routine care among adults with epilepsy and baseline anxiety or depression symptoms; these were prespecified secondary outcomes within a pragmatic randomized trial of remote assessment methods. METHODS: Adults with anxiety or depression symptoms and no suicidal ideation were recruited from a tertiary epilepsy clinic via an electronic health record (EHR)-embedded process. Participants were randomized 1:1 to 6 month outcome collection via patient portal EHR questionnaires vs. telephone interview. This report focuses on an a priori secondary outcomes of the overall trial, focused on patient-reported health outcomes in the full sample. Quality of life, (primary health outcome), anxiety, and depression measures were collected at 3 and 6 months (Quality of Life in Epilepsy-10, QOLIE-10, Generalized Anxiety Disorder-7, Neurological Disorders Depression Inventory-Epilepsy). Change values and 95 % confidence intervals were calculated. In post-hoc exploratory analyses, patient-reported anxiety/depression management plans at baseline clinic visit and healthcare utilization were compared with EHR-documentation, and agreement was calculated using the kappa statistic. RESULTS: Overall, 30 participants (15 per group) were recruited and analyzed, of mean age 42.5 years, with 60 % women. Mean 6-month change in QOLIE-10 overall was 2.0(95 % CI -6.8, 10.9), and there were no significant differences in outcomes between the EHR and telephone groups. Mean anxiety and depression scores were stable across follow-up (all 95 % CI included zero). Outcomes were similar regardless of whether an anxiety or depression action plan was documented. During the baseline interview, most participants with clinic visit EHR documentation indicating action to address anxiety and/or depression reported not being offered a treatment(7 of 12 with action plan, 58 %), and there was poor agreement between patient report and EHR documentation (kappa=0.22). Healthcare utilization was high: 40 % had at least one hospitalization or emergency/urgent care visit reported and/or identified via EHR, but a third (4/12) failed to self-report an EHR-identified hospitalization/urgent visit. DISCUSSION: Over 6 months of usual care among adults with epilepsy and anxiety or depression symptoms, there was no significant average improvement in quality of life or anxiety/depression, suggesting a need for interventions to enhance routine neurology care and achieve quality of life improvement for this group.

The peaceful mind program: a pilot test of a cognitive-behavioral therapy-based intervention for anxious patients with dementia.

OBJECTIVES: To assess feasibility and to conduct a preliminary evaluation of outcomes following Peaceful Mind, a cognitive-behavioral therapy-based intervention for anxiety in dementia, relative to usual care. DESIGN: Pilot randomized controlled trial including assessments at baseline and 3 and 6 months. SETTING: Houston, TX. PARTICIPANTS: Thirty-two outpatients diagnosed with mild (47%) or moderate (53%) dementia receiving care through outpatient clinics at the Veterans Affairs medical center, Baylor College of Medicine, Harris County Hospital District, and community day centers for dementia, and their collaterals, who spent at least 8 hours a week with them. INTERVENTION: Peaceful Mind included up to 12 weekly in-home sessions (mean: 8.7, SD: 2.27) during the initial 3 months and up to eight brief telephone sessions (mean: 5.4, SD: 3.17) during months 3-6, involving self-monitoring for anxiety, deep breathing, and optional skills (coping self-statements, behavioral activation, and sleep management). Patients learned skills, and collaterals served as coaches. In usual care, patients received diagnostic feedback, and providers were informed of inclusion status. MEASUREMENTS: Neuropsychiatric Inventory-Anxiety subscale, Rating Anxiety in Dementia scale, Penn State Worry Questionnaire-Abbreviated, Geriatric Anxiety Inventory, Geriatric Depression Scale, Quality of Life in Alzheimer disease, Patient Health Questionnaire, and Client Satisfaction Questionnaire. RESULTS: Feasibility was demonstrated with regard to recruitment, attrition, and treatment characteristics. At 3 months, clinicians rated patients receiving Peaceful Mind as less anxious, and patients rated themselves as having higher quality of life; collaterals reported less distress related to loved ones' anxiety. Although significant positive effects were not noted in other outcomes or at 6-month follow-up, the pilot nature of the trial prohibits conclusions about efficacy. CONCLUSIONS: Results support that Peaceful Mind is ready for future comparative clinical trials.

Reducing Anxiety and Dyspnea via Device-Guided Breathing (RELAX): A Multi-Site Feasibility Study in Post-Treatment Lung Cancer Survivors at Community Cancer Clinics (WF-01213).

INTRODUCTION: Anxiety and dyspnea are 2 common symptoms for lung cancer survivors. Although research suggests decreasing respiration rate can reduce anxiety in several populations, potential benefits of device-guided breathing have not been studied in lung cancer survivors. This feasibility study (WF-01213) provides estimates of accrual, adherence, retention, and preliminary efficacy of 2 doses of a device-guided breathing intervention versus a usual breathing control group for improving self-reported anxiety and dyspnea in post-treatment lung cancer survivors. METHODS: Stage I-IV lung cancer survivors were recruited through the NCI Community Oncology Research Program (NCORP) and randomized to 12 weeks of a device-guided breathing intervention (high dose vs. low dose) or control device. Self-reported outcomes (anxiety, depression, dyspnea, cancer-related worry, fatigue) were assessed at baseline, mid-intervention (Week-6), and post-intervention (Week-12). RESULTS: Forty-six participants (ages 41-77, median = 65; 78% White) were randomized to the high-dose intervention (n = 14), low-dose intervention (n = 14), or control (n = 18) groups between July 2015 and September 2019. Study accrual rate was 0.92 per month for 50 months (projected accrual was 6.3/month). Fourteen participants (30%) withdrew early from the study, with almost half of those discontinuing at or immediately following baseline assessment. No participants were adherent with the intervention per protocol specifications. The proportion minimally adherent (using device at least 1x/week) was 43% (6/14), 64% (9/14), and 61% (11/18) for high-dose, low-dose, and control groups, respectively. Anxiety significantly decreased from baseline for all groups at Week 12. Adherence to the intervention was low across all treatment groups. CONCLUSIONS: This study did not establish feasibility of a community-based randomized trial of 2 doses of device-guided breathing and a control group using an identical-looking device for lung cancer survivors. In both the high-dose and control groups, there were significant improvements from baseline for anxiety and dyspnea. In the low-dose group, there were significant improvements from baseline for anxiety and depression. Ratings and feedback on the intervention were mixed (although leaned in a positive direction). Participants reported liking the feeling of relaxation/calm, helping others, breathing awareness, and music. Participants reporting liking least finding/making time to use the device, frustration with the device, and completing study forms. TRIAL REGISTRATION: CLINICAL TRIALS ID: NCT02063828, clinicaltrials.gov.

A randomized controlled trial of telephone-delivered cognitive-behavioral therapy for late-life anxiety disorders.

OBJECTIVES: Older adults face a number of barriers to receiving psychotherapy, such as a lack of transportation and access to providers. One way to overcome such barriers is to provide treatment by telephone. The purpose of this study was to examine the effects of cognitive behavioral therapy delivered by telephone (CBT-T) to older adults diagnosed with an anxiety disorder. DESIGN: Randomized controlled trial. SETTING: Participants' homes. PARTICIPANTS: Sixty participants age 60 and older with a diagnosis of generalized anxiety disorder, panic disorder, or anxiety disorder not otherwise specified. INTERVENTION: CBT-T versus information-only comparison. MEASUREMENTS: Coprimary outcomes included worry (Penn State Worry Questionnaire) and general anxiety (State Trait Anxiety Inventory). Secondary outcomes included clinician-rated anxiety (Hamilton Anxiety Rating Scale), anxiety sensitivity (Anxiety Sensitivity Index), depressive symptoms (Beck Depression Inventory), quality of life (SF-36), and sleep (Insomnia Severity Index). Assessments were completed prior to randomization, immediately upon completion of treatment, and 6 months after completing treatment. RESULTS: CBT-T was superior to information-only in reducing general anxiety (ES = 0.71), worry (ES = 0.61), anxiety sensitivity (ES = 0.85), and insomnia (ES = 0.82) at the posttreatment assessment; however, only the reductions in worry were maintained by the 6-month follow-up assessment (ES = 0.80). CONCLUSIONS: These results suggest that CBT-T may be efficacious in reducing anxiety and worry in older adults, but additional sessions may be needed to maintain these effects.

A Randomized Preference Trial Comparing Cognitive-Behavioral Therapy and Yoga for the Treatment of Late-Life Worry: Examination of Impact on Depression, Generalized Anxiety, Fatigue, Pain, Social Participation, and Physical Function.

Background: Depression, generalized anxiety, fatigue, diminished physical function, reduced social participation, and pain are common for many older adults and negatively impact quality of life. The purpose of the overall trial 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. Objective: The present analyses compared effects of the 2 interventions on additional outcomes (depressive symptoms, generalized anxiety symptoms, fatigue, pain interference/intensity, physical function, social participation); and examined whether there are preference and selection effects for these treatments. Methods: A randomized preference trial of CBT and yoga was conducted in adults ≥60 years who scored ≥26 on the Penn State Worry Questionnaire-Abbreviated (PSWQ-A), recruited from outpatient medical clinics, mailings, and advertisements. Cognitive-behavioral therapy consisted of 10 weekly telephone sessions. Yoga consisted of 20 bi-weekly group yoga classes. Participants were randomized to(1): a randomized controlled trial (RCT) of CBT or yoga (n = 250); or (2) a preference trial in which they selected their treatment (CBT or yoga; n = 250). Outcomes were measured at baseline and post-intervention. Results: Within the RCT, there were significant between-group differences for both pain interference and intensity. The pain interference score improved more for the CBT group compared with the yoga group [intervention effect of (mean (95% CI) = 2.5 (.5, 4.6), P = .02]. For the pain intensity score, the intervention effect also favored CBT over yoga [.7 (.2, 1.3), P < .01]. Depressive symptoms, generalized anxiety, and fatigue showed clinically meaningful within-group changes in both groups. There were no changes in or difference between physical function or social participation for either group. No preference or selection effects were found. Conclusion: Both CBT and yoga may be useful for older adults for improving psychological symptoms and fatigue. Cognitive-behavioral therapy may offer even greater benefit than yoga for decreasing pain.

Patient-reported outcomes via electronic health record portal versus telephone: a pragmatic randomized pilot trial of anxiety or depression symptoms in epilepsy.

Objective: To close gaps between research and clinical practice, tools are needed for efficient pragmatic trial recruitment and patient-reported outcome collection. The objective was to assess feasibility and process measures for patient-reported outcome collection in a randomized trial comparing electronic health record (EHR) patient portal questionnaires to telephone interview among adults with epilepsy and anxiety or depression symptoms. Materials and Methods: Recruitment for the randomized trial began at an epilepsy clinic visit, with EHR-embedded validated anxiety and depression instruments, followed by automated EHR-based research screening consent and eligibility assessment. Fully eligible individuals later completed telephone consent, enrollment, and randomization. Participants were randomized 1:1 to EHR portal versus telephone outcome assessment, and patient-reported and process outcomes were collected at 3 and 6 months, with primary outcome 6-month retention in EHR arm (feasibility target: ≥11 participants retained). Results: Participants (N = 30) were 60% women, 77% White/non-Hispanic, with mean age 42.5 years. Among 15 individuals randomized to EHR portal, 10 (67%, CI 41.7%-84.8%) met the 6-month retention endpoint, versus 100% (CI 79.6%-100%) in the telephone group (P = 0.04). EHR outcome collection at 6 months required 11.8 min less research staff time per participant than telephone (5.9, CI 3.3-7.7 vs 17.7, CI 14.1-20.2). Subsequent telephone contact after unsuccessful EHR attempts enabled near complete data collection and still saved staff time. Discussion: In this randomized study, EHR portal outcome assessment did not meet the retention feasibility target, but EHR method saved research staff time compared to telephone. Conclusion: While EHR portal outcome assessment was not feasible, hybrid EHR/telephone method was feasible and saved staff time.