An exploration into the relationship between insomnia and repetitive negative thinking among cancer survivors.

OBJECTIVE: Insomnia and repetitive negative thinking (RNT) are both prevalent among cancer survivors, yet little work has investigated their interrelationship. To explore the hypothesis that RNT and insomnia are related, we conducted secondary analyses on data from a pilot clinical trial of cognitive behavioral therapy for insomnia (CBT-I) for cancer survivors. METHODS: This study analyzed survey data from 40 cancer survivors with insomnia who participated in a pilot randomized trial of CBT-I. Correlations and linear regression models were used to determine associations between aspects of RNT and related constructs (fear of cancer recurrence [FCR], cancer-specific rumination, worry, and intolerance of uncertainty) and sleep (insomnia and sleep quality), while accounting for psychiatric symptoms such as anxiety and depression. Treatment-related change in RNT was examined using a series of linear mixed models. RESULTS: Evidence for an association between RNT and insomnia among cancer survivors emerged. Higher levels of FCR and cancer-related rumination were correlated with more severe insomnia symptoms and worse sleep quality. Notably, FCR levels predicted insomnia, even after controlling for anxiety and depression. Results identified potential benefits and limitations of CBT-I in addressing RNT that should be examined more thoroughly in future research. CONCLUSIONS: RNT is a potential target to consider in insomnia treatment for cancer survivors.

Validation of the Lee-Jones theoretical model of fear of cancer recurrence among breast cancer survivors using a structural equation modeling approach.

OBJECTIVE: The Lee-Jones model posits that antecedent individual and interpersonal factors predicate the development of fear of cancer recurrence (FCR) through cognitive and emotional processing, which further to behavioral, emotional, and/or physiological responses. We analyzed data from FoRtitude, a FCR intervention grounded in the Lee-Jones FCR model, to evaluate associations between FCR antecedents, resources (e.g., breast cancer self-efficacy, BCSE) and psychological and behavioral consequences. METHODS: Women with breast cancer who completed treatment and reported clinically elevated levels of FCR were randomized into a 4-week online psychosocial intervention or contact control group. We assessed BCSE, FCR, and physical activity, anxiety and depression, or symptoms at baseline, 4 and 8 weeks. Separate structural equation models were constructed with both baseline data and change scores (baseline-8 weeks) to examine the pathways linking BCSE, FCR and: (1) physical activity; (2) anxiety and depression; and (3) symptoms (fatigue, sleep disturbance, cognitive concerns). RESULTS: At baseline, higher levels of BCSE were associated with lower levels of FCR. Higher FCR was associated with worse psychological effects and symptoms but not behavioral response. Change models revealed that an increase in BCSE was associated with a decrease in FCR at 8-week assessment, which was associated with reductions in psychological effects. A change in BCSE was also directly associated with reductions in psychological effects. CONCLUSIONS: Results support the Lee-Jones model as a foundation for FCR interventions among breast cancer survivors. Replicability among varied populations is needed to examine effects on behavioral outcomes of FCR such as health care utilization. CLINICAL TRIALS REGISTRATION: NCT03384992.

Posttraumatic Cognitions and Condomless Sex Among Men Who Have Sex with Men (MSM) with a History of Childhood Sexual Abuse: The Role of Avoidance Coping.

This study explicated associations between trauma-related cognitions and condomless sex, examining avoidance coping style and behavior (i.e., substance use) as intermediate variables, among a group disproportionately affected by both trauma and HIV. Two hundred and ninety HIV-negative MSM with a history of childhood sexual abuse (CSA) completed a cross-sectional psychosocial battery. Trauma-related cognitions were positively associated with more acts of condomless sex. Indirect associations on condomless sex were driven by avoidance coping, but not substance use. Findings indicate a need to address trauma-related cognitions and avoidance coping within interventions for reducing HIV risk among MSM with a history of CSA.

Representation of race and ethnicity among cancer survivors in trials of cognitive behavioral therapy for insomnia (CBT-I): A systematic review.

PURPOSE: For cancer survivors, insomnia is highly prevalent and debilitating. Although cognitive behavioral therapy for insomnia (CBT-I) is recognized as a gold standard treatment, it is unclear whether benefits of treatment generalize to racial and ethnic minorities in the USA. This systematic review characterizes the representation of racial and ethnic diversity among cancer survivors in CBT-I clinical trials and provides recommendations for research in sleep/cancer survivorship. METHODS: Literature searches were conducted in five electronic databases (PubMed, Cochrane Library via Ovid, PsycINFO via Ovid, Embase, Web of Science Core Collection) using concepts of CBT, insomnia, and cancer survivors. Information about CBT-I intervention details, sample racial demographics, and whether authors explicitly analyzed race and ethnicity were recorded. RESULTS: A total of 1673 citations were retrieved, and 967 citations were uploaded to Covidence. Of these, 135 articles went through full-text review and 13 studies were included. Race and ethnicity were reported in 11/13 trials (84.6%). Of those reporting race and ethnicity, 8/11 (72.7%) trials were comprised of samples that were ≥ 85% non-Hispanic White. Among the trials that explicitly analyzed race and ethnicity, CBT-I was more effective among cancer survivors who were White and highly educated, and non-White cancer survivors were less likely to have private insurance and ability to participate in clinical trials. CONCLUSION: Non-Hispanic White cancer survivors are overrepresented in CBT-I trials, the best available treatment for insomnia. Underrepresentation of racial and ethnic minorities likely contributes to barriers in access and uptake. Recommendations include implementing sustained efforts to expand diversity in CBT-I clinical trials for cancer survivors.

Do cancer curvivors and metavivors have distinct needs for stress management intervention? Retrospective analysis of a mind-body survivorship program.

PURPOSE: Cancer "curvivors" (completed initial curative intent treatment with surgery, radiation, chemotherapy, and/or other novel therapies) and "metavivors" (living with metastatic or chronic, incurable cancer) experience unique stressors, but it remains unknown whether these differences impact benefits from mind-body interventions. This study explored differences between curvivors and metavivors in distress (depression, anxiety, worry) and resiliency changes over the course of an 8-week group program, based in mind-body stress reduction, cognitive-behavioral therapy (CBT), and positive psychology. METHODS: From 2017-2021, 192 cancer survivors (83% curvivors; 17% metavivors) completed optional online surveys of resiliency (CES) and distress (PHQ-8, GAD-7, PSWQ-3) pre- and post- participation in an established clinical program. Mixed effect regression models explored curvivor-metavivor differences at baseline and in pre-post change. RESULTS: Compared to curvivors, metavivors began the program with significantly more resilient health behaviors (B = 0.99, 95% CI[0.12, 1.86], p = .03) and less depression (B = -2.42, 95%CI[-4.73, -0.12], p = .04), with no other significant differences. Curvivors experienced significantly greater reductions in depression (curvivor-metavivor difference in strength of change = 2.12, 95% CI [0.39, 3.83], p = .02) over the course of the program, with no other significant differences. Neither virtual delivery modality nor proportion of sessions attended significantly moderated strength of resiliency or distress change. CONCLUSION: Metavivors entering this mind-body program had relatively higher well-being than did curvivors, and both groups experienced statistically comparable change in all domains other than depression. Resiliency programming may thus benefit a variety of cancer survivors, including those living with incurable cancer.

The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors.

BACKGROUND: For cancer survivors, insomnia is prevalent, distressing, and persists for years if unmanaged. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment yet can be difficult to access and may require modification to address survivorship-specific barriers to sleep. In this 2-phase study, the authors adapted and assessed the feasibility, acceptability, and preliminary effects of synchronous, virtual CBT-I adapted for cancer survivors (the Survivorship Sleep Program [SSP]). METHODS: From April to August 2020, cancer survivors with insomnia (N = 10) were interviewed to refine SSP content and delivery. From October 2020 to March 2021, 40 survivors were recruited for a randomized controlled trial comparing 4 weekly SSP sessions with enhanced usual care (EUC) (CBT-I referral plus a sleep hygiene handout). Feasibility and acceptability were assessed by enrollment, retention, attendance, fidelity, survey ratings, and exit interviews. Insomnia severity (secondary outcome), sleep quality, sleep diaries, and fatigue were assessed at baseline, postintervention, and at 1-month follow-up using linear mixed models. RESULTS: The SSP included targeted content and clinician-led, virtual delivery to enhance patient centeredness and access. Benchmarks were met for enrollment (56% enrolled/eligible), retention (SSP, 90%; EUC, 95%), attendance (100%), and fidelity (95%). Compared with EUC, the SSP resulted in large, clinically significant improvements in insomnia severity (Cohen d = 1.19) that were sustained at 1-month follow-up (Cohen d = 1.27). Improvements were observed for all other sleep metrics except sleep diary total sleep time and fatigue. CONCLUSIONS: Synchronous, virtually delivered CBT-I targeted to cancer survivors is feasible, acceptable, and seems to be efficacious for reducing insomnia severity. Further testing in larger and more diverse samples is warranted.

Testing psychosocial mediators of a mind-body resiliency intervention for cancer survivors.

PURPOSE: Group-based mind-body interventions such as the Stress Management and Resiliency Training-Relaxation Response Resiliency Program (SMART-3RP) hold promise for enhancing resiliency among cancer survivors. Mechanisms underlying improvements in psychological outcomes are theoretically established but remain unexamined empirically. METHODS: Adult cancer survivors (n = 105) participating in the SMART-3RP completed surveys of resiliency and five hypothesized mediators: coping (ability to relax physical tension and assertive social support-seeking), mindfulness, positive affect, and worry. Pre-post intervention changes were assessed using repeated-measures t-tests. Bivariate correlations between change scores and a more conservative within-person parallel mediation model tested covariance between resiliency and mediators. RESULTS: Participants experienced moderate to large improvements in all patient-reported outcomes (ds = 1.01-0.46). Increased resiliency was significantly associated with increases in mindfulness, positive affect, and assertive social support-seeking (rs = 0.36-0.50); smaller associations with increased relaxation and decreased worry were not significant. Mindfulness and positive affect explained the largest proportion of variance in resiliency increase in the full multivariate model. CONCLUSIONS: Cancer survivors completing the SMART-3RP had increased resiliency, which was associated with improvements in mindfulness, positive affect, and the ability to assertively seek social support. Enhancing mindfulness and positive affect were critical components for enhancing resiliency. Implications for resiliency interventions with cancer survivors are discussed.

A spotlight on avoidance coping to manage fear of recurrence among breast cancer survivors in an eHealth intervention.

BACKGROUND: Fear of recurrence (FoR) is prevalent among breast cancer survivors (BCS) and may be exacerbated by avoidance coping. This study examined BCS with avoidance coping and their engagement in a FoR eHealth intervention (FoRtitude). METHODS: BCS (N = 196) with elevated FoR participated in FoRtitude. Patient-reported measures assessed avoidance coping with FoR and baseline emotional and behavioral health. Intervention engagement was measured quantitatively (e.g., website logins, telecoaching attendance) and qualitatively (i.e., telecoaching notes). RESULTS: 38 BCS (19%) endorsed avoidance coping, which was associated with more severe post-traumatic anxiety-related symptoms and worse global mental health (ps < .05), but not anxiety (p = .19), depression (p = .11), physical health (p = .12), alcohol consumption (p = .85), or physical activity (p = .39). Avoidance coping was not associated with engagement levels (ps > .05) but did characterize engagement-related motivators and barriers. CONCLUSIONS: Avoidance coping was not a barrier to FoRtitude engagement. eHealth delivery is a promising modality for engaging survivors with avoidance coping in FoR interventions.

Relationship between adverse childhood experiences and anxiety symptoms among Chinese adolescents: The role of self-compassion and social support.

Previous studies have revealed that adverse childhood experiences (ACEs) create a significant and lasting effect of increased anxiety. However, few studies have examined the mediating and moderating mechanisms underlying this relation. The present study aimed to explore the mediating role of self-compassion and moderating role of social support in ACEs-anxiety relationship among Chinese adolescents. In this cross-sectional study, 1,764 middle school students completed questionnaires measuring their levels of ACEs, anxiety, self-compassion (SC), and social support. Correlations of variables were computed using Pearson's r. Mediation and moderated mediation models were tested using PROCESS macro with the regression bootstrapping method. After covariates (age and gender) were controlled, results showed that: (1) ACEs were positively associated with anxiety symptoms; (2) self-compassion partially mediated the ACEs-anxiety association; (3) both ACEs-anxiety and SC-anxiety relationships were moderated by social support. Specifically, social support was associated with lower anxiety, particularly among students with fewer ACEs or lower level of self-compassion. Reducing possible adversities existing in environment may help to reduce risk of anxiety for adolescents. Cultivating self-compassion is crucial for adolescents' mental health, since it may play a role in ACEs-anxiety relationship. Social support would operate as a buffer to ACEs in the relation with anxiety, under the circumstances of mild adversities, and a promoter to self-compassion in the relation with anxiety, under the circumstances of low self-compassion.

COVID-19 uncertainty and sleep: the roles of perceived stress and intolerance of uncertainty during the early stage of the COVID-19 outbreak.

BACKGROUND: The COVID-19 pandemic brings unprecedented uncertainty and stress. This study aimed to characterize general sleep status among Chinese residents during the early stage of the outbreak and to explore the network relationship among COVID-19 uncertainty, intolerance of uncertainty, perceived stress, and sleep status. METHODS: A cross-sectional correlational survey was conducted online. A total of 2534 Chinese residents were surveyed from 30 provinces, municipalities, autonomous regions of China and regions abroad during the period from February 7 to 14, 2020, the third week of lockdown. Final valid data from 2215 participants were analyzed. Self-report measures assessed uncertainty about COVID-19, intolerance of uncertainty, perceived stress, and general sleep status. Serial mediation analysis using the bootstrapping method and path analysis were applied to test the mediation role of intolerance of uncertainty and perceived stress in the relationship between uncertainty about COVID-19 and sleep status. RESULTS: The total score of sleep status was 4.82 (SD = 2.72). Age, place of residence, ethnicity, marital status, infection, and quarantine status were all significantly associated with general sleep status. Approximately half of participants (47.1%) reported going to bed after 12:00 am, 23.0% took 30 min or longer to fall asleep, and 30.3% slept a total of 7 h or less. Higher uncertainty about COVID-19 was significantly positively correlated with higher intolerance of uncertainty (r = 0.506, p < 0.001). The mediation analysis found a mediating role of perceived stress in the relationship between COVID-19 uncertainty and general sleep status (ß = 0.015, 95%C.I. = 0.009-0.021). However, IU was not a significant mediator of the relationship between COVID-19 uncertainty and sleep (ß = 0.009, 95%C.I. = - 0.002-0.020). Moreover, results from the path analysis further showed uncertainty about COVID-19 had a weak direct effect on poor sleep (ß = 0.043, p < 0.05); however, there was a robust indirect effect on poor sleep through intolerance of uncertainty and perceived stress. CONCLUSIONS: These findings suggest that intolerance of uncertainty and perceived stress are critical factors in the relationship between COVID-19 uncertainty and sleep outcomes. Results are discussed in the context of the COVID-19 pandemic, and practical policy implications are also provided.

Changes in Perceived Stress After Yoga, Physical Therapy, and Education Interventions for Chronic Low Back Pain: A Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVE: Perceived stress and musculoskeletal pain are common, especially in low-income populations. Studies evaluating treatments to reduce stress in patients with chronic pain are lacking. We aimed to quantify the effect of two evidence-based interventions for chronic low back pain (cLBP), yoga and physical therapy (PT), on perceived stress in adults with cLBP. METHODS: We used data from an assessor-blinded, parallel-group randomized controlled trial, which recruited predominantly low-income and racially diverse adults with cLBP. Participants (N = 320) were randomly assigned to 12 weeks of yoga, PT, or back pain education. We compared changes in the 10-item Perceived Stress Scale (PSS-10) from baseline to 12- and 52-week follow-up among yoga and PT participants with those receiving education. Subanalyses were conducted for participants with elevated pre-intervention perceived stress (PSS-10 score ≥17). We conducted sensitivity analyses using various imputation methods to account for potential biases in our estimates due to missing data. RESULTS: Among 248 participants (mean age = 46.4 years, 80% nonwhite) completing all three surveys, yoga and PT showed greater reductions in PSS-10 scores compared with education at 12 weeks (mean between-group difference = -2.6, 95% confidence interval [CI] = -4.5 to -0.66, and mean between-group difference = -2.4, 95% CI = -4.4 to -0.48, respectively). This effect was stronger among participants with elevated pre-intervention perceived stress. Between-group effects had attenuated by 52 weeks. Results were similar in sensitivity analyses. CONCLUSIONS: Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.

Theoretical Rationale and Case Illustration of Mindfulness-Based Cognitive Therapy for Fear of Cancer Recurrence.

Fear of cancer recurrence (FCR) is a common problem among cancer survivors and evidence-based interventions grounded in theoretical models are needed. Mindfulness-Based Cognitive Therapy (MBCT) is an evidence-based intervention for reducing health anxiety that could be useful to apply to FCR. However, there has only been one study of MBCT for FCR to date, and the theoretical rationale and practical application of MBCT for FCR has not been described. The purpose of this paper is to offer an evidence-based rationale for MBCT to treat FCR based on a health anxiety model; describe the process of adapting MBCT to target FCR; and present a case study of the adapted protocol for treating FCR in a young adult breast cancer survivor to illustrate its delivery, feasibility, acceptability, and associated changes in outcomes. Clinical implications and directions for future research are discussed.

Mind-body interventions for fear of cancer recurrence: A systematic review and meta-analysis.

OBJECTIVE: Fear of cancer recurrence (FCR) is a common existential concern and source of distress among adults with a cancer history. Multiple randomized controlled trials (RCTs) have examined mind-body approaches to mitigating FCR. We summarized characteristics of these trials and calculated their pooled effects on decreasing FCR. METHODS: Six electronic databases were systematically searched from inception to May 2017, using a strategy that included multiple terms for RCTs, cancer, mind-body medicine, and FCR. Data extraction and reporting followed Cochrane and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Pooled effect sizes on self-report measures of FCR were computed by using random-effects models. RESULTS: Nineteen RCTs (pooled N = 2806) were included. Most studies (53%) were published since 2015 and targeted a single cancer type (84%; mostly breast). Intervention sessions (median = 6, mode = 4) tended to last 120 minutes and occur across 1.5 months. Delivery was predominantly in-person (63%) to either groups (42%) or individuals (42%). Most interventions incorporated multiple mind-body components (53%), commonly cognitive-behavioral skills (58%), or meditative practices (53%). Small-to-medium pooled effect sizes were observed postintervention (Hedges' g = -0.36, 95% CI = -0.49, -0.23, P < .001) and at follow-up assessments (median = 8 months, P < .001). Potential modifiers (control group design, group/individual delivery, use of cognitive-behavioral or mindfulness skills, number of mind-body components, cancer treatment status, and number of sessions) did not reach statistical significance. CONCLUSIONS: Mind-body interventions are efficacious for reducing FCR, with small-to-medium effect sizes that persist after intervention delivery ends. Recommendations include testing effects among survivors of various cancers and exploring the optimal integration of mind-body practices for managing fundamental uncertainties and fears during cancer survivorship.

Fear of recurrence or progression as a link between somatic symptoms and perceived stress among cancer survivors.

PURPOSE: Many cancer survivors report experiencing somatic symptoms as well as elevated stress. Theoretical models have suggested that physical symptoms generate subjective stress via fears of recurrence or progression. To date, this indirect effect has not been established empirically. This study aimed to provide preliminary evidence as to whether fear of recurrence or progression is an intermediary between somatic symptom severity and perceived stress among heterogeneous cancer survivors. METHODS: Adult cancer survivors (N = 67; median 2.4 years since diagnosis; 34% male) presenting at a hospital survivorship clinic completed measures assessing somatic symptom severity (Patient Health Questionnaire-15 (PHQ-15)), perceived stress (four-item Perceived Stress Scale (PSS-4)), and fear of recurrence or progression (Assessment of Survivor Concerns (ASC)). Interrelatedness among variables was assessed using Pearson correlations. Indirect effects were modeled using 5000-iteration bootstrapping. RESULTS: Survivors endorsed a range of somatic symptom severity (29% minimal, 39% low, 18% medium, and 14% high). Somatic symptoms, perceived stress, and fear of recurrence or progression were all significantly positively correlated (rs 0.29 to 0.47). Controlling for time since diagnosis, there was a significant indirect effect of somatic symptom severity on stress via fear of recurrence or progression [B = 0.06, SE = 0.04 (95% CI 0.01-0.16)]. The model accounted for more than one third of the variance in perceived stress [R 2 = 0.35, F(3,54) = 9.59, p < 0.001]. CONCLUSIONS: Survivors with greater somatic symptoms tended to report higher levels of stress, due in part to elevated fears of recurrence or progression. Our findings support concerns about recurrence or progression as a mechanism underlying stress states in cancer survivors. Efforts to assist survivors with stress management should teach strategies for managing cancer-related uncertainties stemming from somatic symptoms.

Integrity of Literature on Expressed Emotion and Relapse in Patients with Schizophrenia Verified by a p-Curve Analysis.

There is growing concern that much published research may have questionable validity due to phenomena such as publication bias and p-hacking. Within the psychiatric literature, the construct of expressed emotion (EE) is widely assumed to be a reliable predictor of relapse across a range of mental illnesses. EE is an index of the family climate, measuring how critical, hostile, and overinvolved a family member is toward a mentally ill patient. No study to date has examined the evidential value of this body of research as a whole. That is to say, although many studies have shown a link between EE and symptom relapse, the integrity of the literature from which this claim is derived has not been tested. In an effort to confirm the integrity of the literature of EE predicting psychiatric relapse in patients with schizophrenia, we conducted a p-curve analysis on all known studies examining EE (using the Camberwell Family Interview) to predict psychiatric relapse over a 9- to 12-month follow-up period. Results suggest that the body of literature on EE is unbiased and has integrity, as there was a significant right skew of p-values, a nonsignificant left skew of p-values, and a nonsignificant test of flatness. We conclude that EE is a robust and valuable predictor of symptom relapse in schizophrenia.

Living with cancer-related uncertainty: associations with fatigue, insomnia, and affect in younger breast cancer survivors.

PURPOSE: Uncertainty in cancer patients and survivors about cancer-related symptoms, treatment, and disease course has been related to poorer mental and physical health. However, little is known about whether cancer-related uncertainty relates with specific disease and treatment-related outcomes such as fatigue, insomnia, and affect disruptions. In this paper, we report these associations in younger survivors aged 50 years or less, a population increasing in prevalence. METHODS: Participants included 313 breast cancer survivors (117 African-Americans and 196 Caucasians) who were aged 24 to 50 years and were 2 to 4 years posttreatment. Self-reported cancer-related uncertainty (Mishel Uncertainty in Illness Scale-Survivor Version), fatigue (Piper Fatigue Scale-Revised), insomnia (Insomnia Severity Index), and negative and positive affect (Positive and Negative Affect Schedule (PANAS)) measures were collected upon study entry. RESULTS: Hierarchical regression analyses controlled for relevant sociodemographic variables include the following: race, age, years of education, number of children, employment status, marital status, monthly income, smoking status, family history of cancer, endorsement of treatment-induced menopause, and religiosity. Over and above these factors, higher cancer-related uncertainty was significantly associated with more self-reported fatigue (ß = .43), insomnia (ß = .34), negative affect (ß = .43), as well as less positive affect (ß = -.33), all ps < .01. CONCLUSIONS: Younger breast cancer survivors who are 2-4 years posttreatment experience cancer-related uncertainty, with higher levels associated with more self-reported psychophysiological disruptions. Cancer survivors who present in clinical settings with high uncertainty about recurrence or management of long-term effects of treatment may thus benefit from assessment of fatigue, insomnia, and affect.

Videoconference-delivered group Cognitive Behavioral Stress Management for ME/CFS patients who present with severe PEM: A randomized controlled trial.

Background: In Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), post-exertional malaise (PEM) is associated with greater distress and symptoms. Cognitive Behavioral Stress Management (CBSM) has demonstrated beneficial effects for ME/CFS and may mitigate stress-related triggers of PEM. We tested a virtual CBSM intervention to increase access, and we report on its effects on stress and symptoms in ME/CFS patients with severe PEM. Methods: Data were from a randomized controlled trial (NCT01650636) comparing 10-week videoconference-delivered group CBSM (V-CBSM, n=75) to a 10-week Health Information active control (V-HI, n=75) in Fukuda criteria ME/CFS patients (71 classified as highPEM, 79 lowPEM). Linear regression explored PEM-by-Treatment interactions on overall symptom frequency and intensity, perceived stress, and fatigue-specific interference and intensity, at 5-month follow-up. Logistic regression tested V-CBSM effects on 5-month PEM status. Analyses controlled for age, gender, race/ethnicity, mode of symptom onset, and time since diagnosis. Results: The sample was middle-aged (47.96±10.89 years), mostly women (87%) and non-Hispanic White (65%), with no group differences on these variables or baseline PEM. For highPEM patients, V-CBSM (versus V-HI) demonstrated medium to large effects on follow-up symptom frequency, symptom intensity, fatigue interference, and fatigue intensity (p's < .05) and trending to significant reductions in perceived stress (p =.07). Differences were not evident for lowPEM patients. Treatment predicted follow-up PEM status at a trend (p = .058), with patients receiving V-CBSM demonstrating half the risk of highPEM classification versus V-HI. Conclusions: V-CBSM demonstrates benefits for ME/CFS patients presenting with severe PEM and may reduce the expression of PEM over time.

Development and feasibility of a virtual, synchronous mind-body resiliency intervention for fathers of children and youth with special healthcare needs.

Background: Fathers of children and youth with special healthcare needs (FCYSHCN) are an overlooked population at risk for chronic stress. Mind-body practices offer a patient-centered approach to foster coping and resiliency, yet low engagement from fathers in existing programs suggests adaptation is needed. This multiphase study examines the feasibility of a synchronous, virtual mind-body intervention adapted for FCYSHCN. Methods: 31 FCYSHCN were recruited online via community partners and recruitment portals in an academic medical center in Boston, MA. Phase 1 consisted of individual interviews (N = 17) to determine fathers' stressors, coping strategies, program needs, and suggested adaptations to the intervention protocol. The Phase 2 single arm pilot feasibility trial (N = 14) consisted of eight weekly 60-minute group sessions delivered virtually. Primary feasibility metrics were attendance (benchmark: mean=6 sessions) and electronic survey completion at baseline and post-intervention. Acceptability was assessed using post-session ratings of program satisfaction (4-point Likert scale; scores ≥3 coded as helpful) and helpfulness (e.g., group structure). Exploratory outcomes included validated measures of stress coping, resiliency, parental stress, depression, anxiety, which were analyzed using paired-samples t-tests (alpha=.05) to generate effect sizes (η2). Results: In Phase 1, FCYSHCN discussed primary stressors (e.g., perceived inadequacy as a father) and multifaceted impacts of these stressors on physical, cognitive, emotional, and social wellbeing. Fathers also described coping strategies deemed helpful (e.g., humor) and unhelpful (e.g., "shutting down" from others). Qualitative findings informed intervention modifications. In Phase 2, most FCYSHCN (79%) attended ≥ 6 intervention sessions (mean=7). Follow-up survey completion was high (86%). Session satisfaction was high, with 7/8 sessions rated as helpful by most fathers. Program components deemed most helpful were the group structure, virtual delivery, exposure to a variety of relaxation and meditation skills, and the length of sessions. Although we were not powered to observe pre-post change, stress coping improved (p = .02, η2 = 0.42) and confidence increased in applying relaxation (p = .04, η2 = 0.34) and assertiveness techniques (p = .05, η2 = 0.31). Conclusions: The first mind-body resiliency program for FCYSHCN is feasible and acceptable. Further testing is warranted in randomized trials with diverse samples of fathers, an appropriate comparison arm, and longitudinal assessments of psychosocial and biobehavioral outcomes.