Acupuncture for Chronic Radiation-Induced Xerostomia in Head and Neck Cancer: A Multicenter Randomized Clinical Trial.

Importance: Patients with head and neck cancer who undergo radiotherapy can develop chronic radiation-induced xerostomia. Prior acupuncture studies were single center and rated as having high risk of bias, making it difficult to know the benefits of acupuncture for treating radiation-induced xerostomia. Objective: To compare true acupuncture (TA), sham acupuncture (SA), and standard oral hygiene (SOH) for treating radiation-induced xerostomia. Design, Setting, and Participants: A randomized, blinded, 3-arm, placebo-controlled trial was conducted between July 29, 2013, and June 9, 2021. Data analysis was performed from March 9, 2022, through May 17, 2023. Patients reporting grade 2 or 3 radiation-induced xerostomia 12 months or more postradiotherapy for head and neck cancer were recruited from community-based cancer centers across the US that were part of the Wake Forest National Cancer Institute Community Oncology Research Program Research Base. Participants had received bilateral radiotherapy with no history of xerostomia. Interventions: Participants received SOH and were randomized to TA, SA, or SOH only. Participants in the TA and SA cohorts were treated 2 times per week for 4 weeks. Those experiencing a minor response received another 4 weeks of treatment. Main Outcomes and Measures: Patient-reported outcomes for xerostomia (Xerostomia Questionnaire, primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General) were collected at baseline, 4 (primary time point), 8, 12, and 26 weeks. All analyses were intention to treat. Results: A total of 258 patients (201 men [77.9%]; mean [SD] age, 65.0 [9.16] years), participated from 33 sites across 13 states. Overall, 86 patients were assigned to each study arm. Mean (SD) years from diagnosis was 4.21 (3.74) years, 67.1% (n = 173) had stage IV disease. At week 4, Xerostomia Questionnaire scores revealed significant between-group differences, with lower Xerostomia Questionnaire scores with TA vs SOH (TA: 50.6; SOH: 57.3; difference, -6.67; 95% CI, -11.08 to -2.27; P = .003), and differences between TA and SA (TA: 50.6; SA: 55.0; difference, -4.41; 95% CI, -8.62 to -0.19; P = .04) yet did not reach statistical significance after adjustment for multiple comparisons. There was no significant difference between SA and SOH. Group differences in Functional Assessment of Cancer Therapy-General scores revealed statistically significant group differences at week 4, with higher scores with TA vs SOH (TA: 101.6; SOH: 97.7; difference, 3.91; 95% CI, 1.43-6.38; P = .002) and at week 12, with higher scores with TA vs SA (TA: 102.1; SA: 98.4; difference, 3.64; 95% CI, 1.10-6.18; P = .005) and TA vs SOH (TA: 102.1; SOH: 97.4; difference, 4.61; 95% CI, 1.99-7.23; P = .001). Conclusions and Relevance: The findings of this trial suggest that TA was more effective in treating chronic radiation-induced xerostomia 1 or more years after the end of radiotherapy than SA or SOH. Trial Registration: ClinicalTrials.gov Identifier: NCT02589938.

Living with type 2 diabetes: A social cognitive perspective on adherence.

OBJECTIVE: This mixed methods study examines the relationship between outcome expectations, self-efficacy, and self-care behaviors in individuals with type 2 diabetes (T2DM). It also explores the personal values motivating these behaviors through in-depth interviews. METHODS: Adults with T2DM (n = 108, M age = 57 years, 58% female, 48% Black) completed questionnaires and participated in in-depth interviews using a laddering technique. RESULTS: Ordinary least squares regression models were used to analyze the relationships between self-efficacy, outcome expectations, and four self-care behaviors (physical activity, dietary choices, blood glucose monitoring, and medication usage). The findings indicate that self-efficacy is significantly and positively associated with diet and physical activity. Both outcome expectations for blood glucose testing and self-efficacy are significantly and positively associated with self-reported monitoring. However, neither outcome expectation nor self-efficacy is associated with medication usage. The in-depth interviews revealed three common values related to self-care behaviors: maintaining health and longevity, agentic values of self-control, achievement, and self-esteem, and a sense of belonging. CONCLUSIONS: This study sheds light on the complexity of diabetes self-management, offering insights into individuals' values, behavioral strategies, and the influence of control perceptions on this relationship, revealing both differences and commonalities in stated values. PRACTICE IMPLICATIONS: By understanding how personal values drive diabetes self-care behaviors, practitioners can assist patients in establishing meaningful connections between their values and the challenges of living with diabetes.

Processes for identifying caregivers and screening for caregiver and patient distress in community oncology: results from WF-1803CD.

BACKGROUND: Despite their vital roles, informal caregivers of adult cancer patients are commonly overlooked in cancer care. This study describes processes for identifying cancer caregivers and processes for distress screening and management among caregivers and patients in the understudied community oncology setting. METHODS: Supportive care leaders from the National Cancer Institute Community Oncology Research Program practices completed online survey questions regarding caregiver identification, caregiver and patient distress screening, and distress management strategies. We described practice group characteristics and prevalence of study outcomes. Multivariable logistic regression explored associations between practice group characteristics and caregiver identification in the electronic health record (EHR). RESULTS: Most (64.9%, 72 of 111) supportive care leaders reported routine identification and documentation of informal caregivers; 63.8% record this information in the EHR. Only 16% routinely screen caregivers for distress, though 92.5% screen patients. Distress management strategies for caregivers and patients are widely available, yet only 12.6% are routinely identified and screened and had at least 1 referral strategy for caregivers with distress; 90.6% are routinely screened and had at least 1 referral strategy for patients. Practices with a free-standing outpatient clinic (odds ratio [OR] = 0.29, P = .0106) and academic affiliation (OR = 0.01, P = .04) were less likely to identify and document caregivers in the EHR. However, higher oncologist volume was associated with an increased likelihood of recording caregiver information in the EHR (OR = 1.04, P = .02). CONCLUSIONS: Despite high levels of patient distress screening and management, few practices provide comprehensive caregiver engagement practices. Existing patient engagement protocols may provide a promising platform to build capacity to better address caregiver needs.

Qualitative results from a randomized pilot study of eHealth Mindful Movement and Breathing to improve gynecologic cancer surgery outcomes.

PURPOSE: Improved management of pain and co-morbid symptoms (sleep disturbances, psychological distress) among women undergoing surgery for suspected gynecologic malignancies may reach a population vulnerable to chronic pain. PARTICIPANTS: Women undergoing surgery for a suspected gynecologic malignancy. METHOD: We conducted a pilot randomized controlled trial of eHealth Mindful Movement and Breathing (eMMB) compared to an empathic attention control (AC). Semi-structured interviews were conducted by telephone (n = 23), recorded, transcribed, coded, and analyzed using thematic analysis. FINDINGS: Participants reported overall high acceptability such that all would recommend the study to others. Positive impacts of practicing eMMB included that it relieved tension, facilitated falling asleep, and decreased pain. Participants also reported high adherence to self-directed eMMB and AC writing practices and described facilitators and barriers to practicing. CONCLUSIONS: This qualitative feedback will inform future research to assess the efficacy of eMMB for reducing pain and use of remotely-delivered interventions more broadly. CLINICAL TRIAL REGISTRATION NUMBER: NCT03681405.

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.

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 pilot of eHealth mindful movement and breathing to improve gynecologic surgery outcomes.

OBJECTIVE: To conduct a pilot randomized controlled trial of eHealth Mindful Movement and Breathing (eMMB) compared to an empathic attention control (AC). PARTICIPANTS: Women undergoing surgery for a suspected gynecologic malignancy. METHODS: eMMB is a brief yoga intervention delivered remotely during the perioperative timeframe. We assessed feasibility and participants completed assessments (baseline, weeks 2 and 4 postoperatively). We summarized feasibility, participant characteristics, and outcomes by intervention group and time. FINDINGS: Forty-three percent of eligible patients approached participated (n = 31). Adherence to the interventions was 77%. Percent of participants to complete outcomes was 81% at Week 2 and 84% at Week 4 (>70%; retention was the primary feasibility indicator). Average reductions in the primary outcome of pain intensity were larger in the eMMB group than AC group (Week 2 d = -0.38; Week 4 d = -0.46). IMPLICATIONS: This pilot study of eMMB supported feasibility and improvements in pain intensity that warrant a future efficacy study.

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.

Financial burden for caregivers of adolescents and young adults with cancer.

OBJECTIVE: Adolescent and young adult (AYA) cancer survivors are vulnerable to cancer-related financial burden, which is likely shared by their caregivers. This study aims to enhance an existing conceptual model of financial burden by conducting concept elicitation interviews with caregivers to generate knowledge that can be translated to inform instrumental and psychosocial support in cancer care. METHODS: Qualitative concept elicitation interviews were conducted with 24 caregivers of AYA cancer survivors (caregivers of adolescents, n = 12; caregivers of emerging adults, n = 12) recruited from four sites. Constant comparative methods were used to identify themes, and results were interpreted and organized into domains of the conceptual model. We also explored COVID-19 related financial impacts among a subset (n = 12) of caregivers. RESULTS: Seven themes emerged, which varied by age group and strengthened the conceptualization of the model. Themes centered on: (1) direct and indirect costs of cancer; (2) impact of socioeconomic status on financial burden; (3) caregiver desire to shield AYAs from distress due to financial burden; (4) strategies to manage cancer-related costs; (5) worries about AYAs' financial future; (6) seeking and receiving financial support; and (7) navigating the healthcare system. Findings also revealed that COVID-19 exacerbates financial burden for some caregivers. CONCLUSIONS: Building upon our prior work, we have adapted the conceptual model of financial burden to reflect perspectives of AYAs, oncology providers, and now, caregivers. An important next step is to develop a reliable and valid self-report measure of financial burden among caregivers of AYA cancer survivors.

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.

Stakeholder-informed conceptual framework for financial burden among adolescents and young adults with cancer.

BACKGROUND: Cancer and its treatments can result in substantial financial burden that may be especially distressing for adolescents and young adults (AYAs) since they are at a developmental stage focused on completing one's education and establishing independence. The purpose of this study was to develop a conceptual model of financial burden among AYA cancer patients to inform development of a financial burden measure. METHODS: In-depth concept elicitation interviews were conducted with a purposive-selected stakeholder sample (36 AYAs and 36 AYA oncology health care providers). The constant comparative method was used to identify themes that illustrate AYAs' experience of financial burden by stakeholder groups. RESULTS: Eleven financial burden themes emerged: (1) impact of socioeconomic status and age; (2) significant cancer costs; (3) indirect cost "ripple effects"; (4) limited awareness of costs (adolescents); (5) emotional impact; (6) feeling overwhelmed navigating the health care system; (7) treatment decision modifications; (8) reducing spending; (9) coping strategies; (10) financial support; and (11) long-lasting impact. The conceptual model highlights the importance of material, psychosocial, and behavioral domains of financial burden with an emphasis on phase along the cancer continuum and developmental stage in the experience of financial burden for AYAs. CONCLUSIONS: Issues presented in the voice of AYA patients and providers highlight the profound impact of financial burden in this survivor group. The next step in this work will be to develop and test a patient-reported measure of financial burden among AYA cancer survivors.

Enhancing Access to Yoga for Older Male Veterans After Cancer: Examining Beliefs About Yoga.

BACKGROUND: Yoga is an effective clinical intervention for cancer survivors. Most studies of the positive effects of yoga on cancer patients report on predominantly middle-aged women with breast cancer. Less is known about the use of yoga in older adults, veterans, and those from diverse racial or ethnic backgrounds. METHODS: We examined strategies to enhance access to yoga in older veterans after cancer, focusing on education (study 1) and intervention (study 2). Study 1 included 110 participants with a median (SD) age of 64.9 (9.4) years who were mostly male (99%) cancer survivors who were interviewed 12 months after their cancer diagnosis. Study 2 included 28 participants with a median (SD) age of 69.2 (10.9) years who were mostly male (96%) cancer survivors who participated in a yoga program within 3 years of their cancer diagnosis. Standardized interviews assessed interest in and barriers to yoga while self-reporting assessed health-related quality of life and beliefs about yoga. RESULTS: In study 1, interest in yoga increased from 5.5 to 31.8% (χ 2 = 22.25, P < .001) following education. In open-ended questions 4 themes related to negative beliefs or barriers emerged: lack of knowledge or skepticism, disinterest or dislike, physical health barriers, and logistical barriers. In study 2, beliefs were more positive following intervention for expected benefits (t = 4.44, P < .001), discomfort (t = 4.92, P < .001), and social norms (t = 4.38, P < .001) related to yoga. Physical function improved after participation in a yoga class, especially for those with higher beliefs in yoga prior to class. Age was not associated with beliefs about yoga in either sample. CONCLUSIONS: A portion of older veterans who are cancer survivors were interested in yoga but faced access barriers. Implications for practice and research include increasing knowledge about yoga benefits and addressing physical health and logistical barriers to enhance access to yoga for older veterans.

Predictors of preference for cognitive-behavioral therapy (CBT) and yoga interventions among older adults.

The purpose of this study was to examine factors that influence a person's choice of cognitive-behavioral therapy (CBT) or yoga, the stability of these preferences, and the impact of preference on engagement and process measures. We conducted a randomized preference trial of CBT and yoga in 500 adults ≥60 years with symptoms of worry. Participants reported their intervention preference, strength of preference, and factors impacting preference. Engagement in the intervention (session completion and dropout rates) was assessed. Process measures included satisfaction with the intervention, therapeutic alliance, and intervention expectancy. Neither intervention preference (48% and 52% chose CBT and yoga, respectively) nor strength of preference differed significantly between the two preference trial groups. Intervention expectancies at baseline among those in the preference trial were approximately 4.5 units (40-point scale) higher for their preferred intervention (p < .0001 within each group). A principal component analysis of factors influencing preference identified three constructs. Using logistic regression, components focused on attitudes about CBT or yoga were predictive of ultimate preference (odds ratio = 11.5, 95% C.I.6.3-21.0 per 1SD difference in component 1 for choosing CBT; odds ratio = 7.8, 95% CI4.3-13.9 per 1SD difference in component 2 for choosing yoga). There were no significant differences between the randomized and preference trials on intervention adherence, completion of assessments, intervention satisfaction, or working alliance. Receiving a preferred treatment had no significant effects on intervention outcomes through participant engagement or process measures. When options are limited, providers may have confidence in offering the most readily available non-pharmacological treatments.

Systematic review of financial burden assessment in cancer: Evaluation of measures and utility among adolescents and young adults and caregivers.

The cost of cancer care is rising and represents a stressor that has significant and lasting effects on quality of life for many patients and caregivers. Adolescents and young adults (AYAs) with cancer are particularly vulnerable. Financial burden measures exist but have varying evidence for their validity and reliability. The goal of this systematic review is to summarize and evaluate measures of financial burden in cancer and describe their potential utility among AYAs and their caregivers. To this end, the authors searched PubMed, Embase, the Cochrane Library, CINAHL, and PsycINFO for concepts involving financial burden, cancer, and self-reported questionnaires and limited the results to the English language. They discarded meeting abstracts, editorials, letters, and case reports. The authors used standard screening and evaluation procedures for selecting and coding studies, including consensus-based standards for documenting measurement properties and study quality. In all, they screened 7250 abstracts and 720 full-text articles to identify relevant articles on financial burden. Eighty-six articles met the inclusion criteria. Data extraction revealed 64 unique measures for assessing financial burden across material, psychosocial, or behavioral domains. One measure was developed specifically for AYAs, and none were developed for their caregivers. The psychometric evidence and study qualities revealed mixed evidence of methodological rigor. In conclusion, several measures assess the financial burden of cancer. Measures were primarily designed and evaluated in adult patient populations with little focus on AYAs or caregivers despite their increased risk of financial burden. These findings highlight opportunities to adapt and test existing measures of financial burden for AYAs and their caregivers.

Ensuring Yoga Intervention Fidelity in a Randomized Preference Trial for the Treatment of Worry in Older Adults.

Introduction: Yoga for treatment of worry in older adults is an intervention that is especially likely to translate into real-world practice. Assessing treatment fidelity improves confidence that effective interventions can be consistently applied and allows researchers to explore if any null results for effectiveness are indeed the result of a lack of intervention efficacy or lack of proper intervention implementation. Methods: This study describes treatment fidelity of a yoga intervention in a randomized preference trial that compared cognitive-behavioral therapy (CBT) and yoga for the treatment of worry, anxiety, and sleep in worried older (≥60 years) adults. Established methods for assessing treatment fidelity of CBT guided the procedure for ensuring that the yoga intervention was delivered as intended. The yoga intervention consisted of 20, 75-min, in-person, group, gentle yoga classes held twice weekly. Results: Six female instructors (mean age = 64 years) taught 660 yoga classes that were videotaped. Ten percent of these classes, stratified by instructor, were randomly selected for review. The average adherence score for yoga instructors was 6.84 (range 4-8). The average competency scores were consistently high, with an average score of 7.24 (range 6-8). Teaching content not included in the protocol occurred in 26 (38.1%) sessions and decreased over time. Observed ratings of instructor adherence were significantly related to ratings of competency. Instructor adherence was also significantly associated with lower participant attendance, but not with any of the other process or outcome measures. Conclusions: The larger range found in adherence relative to competence scores demonstrated that teaching a yoga class according to a protocol requires different skills than competently teaching a yoga class in the community, and these skills improved with feedback. These results may foster dialog between the yoga research and practice communities. Clinical Trial Registration No.: NCT02968238.

Corrigendum to 'A randomized preference trial of cognitive-behavioral therapy and yoga for the treatment of worry in anxious older adults' [Contemp. Clin. Trials Commun. 10 (2018) 169-176].

[This corrects the article DOI: 10.1016/j.conctc.2018.05.002.].

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.