Psychosocial-spiritual well-being is related to resilience and mindfulness in patients with severe and/or life-limiting medical illness.

BACKGROUND: Improvement of psychosocial-spiritual well-being in patients with life-threatening or life-limiting illness is desirable. Resilience and mindfulness are considered to be helpful for enhancing psychosocial-spiritual well-being. Mindfulness-based interventions have been shown to promote resilience to stress and enhance well-being. However, in medical patients, evidence for the associations between mindfulness and resilience is lacking. We hypothesize patients with higher levels of psychosocial-spiritual well-being demonstrate greater resilience and mindfulness. METHODS: 200 patients (mean age = 50.2, SD = 15.5) with serious and or life-limiting illnesses were recruited from the NIH Clinical Center. Patients completed a demographic questionnaire, the NIH-HEALS measure of psychosocial-spiritual well-being, the Connor-Davidson Resilience Scale (CD-RISC-10), and the Mindful Attention Awareness Scale (MAAS). The demographic questionnaire also included a question on current stress level. RESULTS: The NIH-HEALS was positively correlated to CD-RISC-10 (rs=0.44, p < 0.001) and MAAS (rs=0.32, p < 0.001). These findings were consistent across all three NIH-HEALS factors. Additionally, CD-RISC-10 and MAAS demonstrated a meaningful relationship to each other (rs=0.46, p < 0.001). All three constructs were inversely related to current stress level. CONCLUSIONS: Findings suggest that there is a meaningful relationship between psychosocial-spiritual well-being, mindfulness, and resilience. Mindfulness and resilience are positively correlated in a medical population. Clinical interventions aimed at enhancing psychosocial-spiritual well-being through mindfulness and resilience can be highly promising for patients with severe and or life limiting illness.

Psilocybin-assisted therapy improves psycho-social-spiritual well-being in cancer patients.

BACKGROUND: While psychedelics have been shown to improve psycho-spiritual well-being, the underlying elements of this change are not well-characterized. The NIH-HEALS posits that psycho-social-spiritual change occurs through the factors of Connection, Reflection & Introspection, and Trust & Acceptance. This study aimed to evaluate the changes in NIH-HEALS scores in a cancer population with major depressive disorder undergoing psilocybin-assisted therapy. METHODS: In this Phase II, single-center, open label trial, 30 cancer patients with major depressive disorder received a fixed dose of 25 mg of psilocybin. Participants underwent group preparation sessions, simultaneous psilocybin treatment administered in adjacent rooms, and group integration sessions, along with individual care. The NIH-HEALS, a self-administered, 35-item measure of psycho-social spiritual healing was completed at baseline and post-treatment at day 1, week 1, week 3, and week 8 following psilocybin therapy. RESULTS: NIH-HEALS scores, representing psycho-social-spiritual wellbeing, improved in response to psilocybin treatment (p < 0.001). All three factors of the NIH-HEALS (Connection, Reflection & Introspection, and Trust & Acceptance) demonstrated positive change by 12.7 %, 7.7 %, and 22.4 %, respectively. These effects were apparent at all study time points and were sustained up to the last study interval at 8 weeks (p < 0.001). LIMITATIONS: The study lacks a control group, relies on a self-report measure, and uses a relatively small sample size with limited diversity that restricts generalizability. CONCLUSIONS: Findings suggest that psilocybin-assisted therapy facilitates psycho-social-spiritual growth as measured by the NIH-HEALS and its three factors. This supports the factors of Connection, Reflection & Introspection, and Trust & Acceptance as underlying elements for psycho-social-spiritual healing in cancer patients, and validates the use of the NIH-HEALS within psychedelic research.

The FACIT-Sp spiritual wellbeing scale: a factor analysis in patients with severe and/or life-limiting medical illnesses.

BACKGROUND: The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp) is a widely used measure of spiritual wellbeing. However, consensus on the best factor structure for this measure has not been reached. Both a 2-factor (Meaning/Peace, Faith) and a 3-factor (Meaning, Peace, Faith) structure are reported in the literature. In this study, we examined the factorial structure of the FACIT-Sp in a population of patients with severe and/or life-limiting medical illnesses. METHODS: The present study is a part of a larger study that validated the National Institute of Health-Healing Experiences of All Life Stressors (NIH-HEALS), a measure of psycho-social-spiritual healing developed by the Pain and Palliative Care Service at the National Institutes of Health Clinical Center (NIH-CC). The sample included 200 subjects who were recruited from the NIH Clinical Center inpatient units and outpatient clinics with severe and/or life limiting illnesses (cancer, non-genetic conditions, genetic conditions, blood dyscrasias). FACIT-Sp is a 12-item questionnaire scored on a 5-point Likert scale (0 = not at all; 4 = very much). Exploratory factor analysis (EFA) and principal component analysis (PCA) were used to analyze results and to identify the number of latent constructs and underlying factor structure. RESULTS: The results supported the 3-factor (Meaning, Peace, and Faith) model of the FACIT-Sp and accounted for the most variability (74.20%), followed by the 2-factor solution (64.95%). The identified factors related to Faith, Peace, and Meaning and were consistent with previously reported 3-factor model. CONCLUSIONS: This study confirmed the 3-factor structure of FACIT-Sp. This information can inform interventions aimed at improving quality of life and spiritual wellbeing in clinical and palliative care settings.

Association of Miglustat With Swallowing Outcomes in Niemann-Pick Disease, Type C1.

Importance: Niemann-Pick disease, type C1 (NPC1) is a progressive neurovisceral disease with no US Food and Drug Administration-approved therapy. Miglustat, a drug used off-label in the United States for the treatment of NPC1, appears to stabilize neurologic disease progression. Several prospective trials suggest that miglustat stabilizes oropharyngeal swallowing function; however, its effect on dysphagia and aspiration risk has not been demonstrated instrumentally. Objective: To determine if miglustat therapy is associated with stabilized swallowing dysfunction in individuals with NPC1. Design, Setting, and Participants: Patients with confirmed NPC1 diagnoses were evaluated in a single-center cohort study of NPC1 from April 1997 to November 2019. Longitudinal data from individuals with neurologic disease onset prior to age 15 years were analyzed. The study population was divided into those with neurologic disease onset in early childhood (age <6 years) and late childhood (age ≥6 years and <15 years). Analysis began September 2019. Exposures: Oral miglustat at baseline and at follow-up. Main Outcomes and Measures: Oropharyngeal swallowing function was assessed with videofluoroscopic swallowing studies. Overall swallowing ability and aspiration risk were evaluated using the American Speech-Language-Hearing Association National Outcome Measurement System swallowing domain and an adapted Rosenbek aspiration-penetration scale, respectively. Results: Overall, 50 participants were evaluated at baseline (median [interquartile range] age, 9.4 [3.4-16.4] years; 26 [52%] female). The median (interquartile range) duration of follow-up was 3.0 (1.1-4.4) years. Miglustat use was associated with decreased odds of worse American Speech-Language-Hearing Association National Outcome Measurement System swallowing domain outcomes in all 3 subsets (overall: odds ratio [OR], 0.09 [95% CI, 0.02-0.36); P < .001; early childhood: OR, 0.17 [95% CI, 0.04-0.67]; P = .01; late childhood: OR, 0.05 [95% CI, 0.01-0.29]; P = .001). Miglustat use was associated with decreased odds of worse Rosenbek aspiration-penetration scale outcomes in the overall cohort (OR, 0.28 [95% CI, 0.08-0.95]; P = .04) but not in each subgroup (early childhood: OR, 0.27 [95% CI, 0.06-1.22]; P = .09; late childhood: OR, 0.38 [95% CI, 0.06-2.33]; P = .29). Conclusions and Relevance: These data suggest that miglustat use is associated with stabilized swallowing function and reduced aspiration risk in NPC1, thus supporting its use in this population. In addition, these data demonstrate that a quantification of swallowing dysfunction can be used as a clinically relevant, functional outcome measure in future therapeutic trials in NPC1.

Effect of a Brief Mindfulness-Based Program on Stress in Health Care Professionals at a US Biomedical Research Hospital: A Randomized Clinical Trial.

Importance: Stress among health care professionals is well documented. The use of mindfulness-based interventions to reduce stress has shown promising results; however, the time commitment of typical programs can be a barrier to successful implementation in health care settings. Objective: To determine the efficacy and feasibility of a brief mindfulness-based program to reduce stress during work hours among health care professionals. Design, Setting, and Participants: This intent-to-treat randomized clinical trial was conducted among full-time health care professionals at the Clinical Center at the National Institutes of Health in Bethesda, Maryland, between September 2017 and May 2018. Participants were randomized to receive mindfulness-based self-care (MBSC) training or life-as-usual control. Data were analyzed from June 2018 to January 2020. Interventions: The MBSC intervention included 5 weekly, 1.5-hour in-class mindfulness practice sessions. Main Outcomes and Measures: Stress level was the primary outcome, assessed with the Perceived Stress Scale 10-Item version. Secondary outcomes included anxiety, burnout, positive and negative affect, mindfulness (trait and state), and self-care. Assessments were taken at baseline and at the end of the intervention (week 5) in the intervention and control groups, and at follow-up (week 13) in the intervention group to test for a maintenance effect. A postprogram evaluation was also obtained. Results: Of 82 randomized participants, 78 who completed the study at week 5 were included in the modified intent-to-treat analysis (median [interquartile range] age, 32 [23-48] years; 65 [83%] women), including 43 participants in the MBSC group and 35 participants in the control group. At the end of the intervention, compared with the control group, the MBSC group had reduced levels of stress (mean [SD] score, 17.29 [5.84] vs 18.54 [6.30]; P = .02) and anxiety (mean [SD] score, 2.58 [1.52] vs 4.23 [1.73]; P < .001), and improved positive affect (mean [SD] score, 35.69 [7.12] vs 31.42 [7.27]; P < .001), state mindfulness (mean [SD] score, 3.74 [1.18] vs 2.78 [1.16]; P < .001), and mindful self-care (mean [SD] score, 7.29 [2.44] vs 5.54 [2.77]; P < .001). Burnout, negative affect, and trait mindfulness levels did not differ between groups. Changes within the MBSC group through follow-up included sustained reductions in stress (change, -6.14; 95% CI, -7.84 to -4.44; P < .001), anxiety (change, -1.46; 95% CI, -1.97 to -0.94; P < .001), trait mindfulness (change, 0.63; 95% CI, 0.36 to 0.90; P < .001), and state mindfulness (change, 1.89; 95% CI, 1.39 to 2.39; P < .001). Conclusions and Relevance: This randomized clinical trial found that this brief mindfulness-based intervention was an effective and feasible means to reduce stress in health care professionals. Larger studies are needed to assess the effects on clinical care and patient outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT03781336.

Gender Differences in Psycho-Social-Spiritual Healing.

Background: Many individuals exhibit significant distress in response to serious and/or life-limiting illness. However, there are others who make life-transforming changes, which involve healing experiences in the psychological, social, and spiritual domains of life regardless of illness outcome. The aim of the present study is to determine if there are any differences in psycho-social-spiritual healing between genders. Materials and Methods: The NIH Healing Experiences in All Life Stressors (NIH-HEALS), a 35-item measure of psycho-social-spiritual healing, is composed of three factors: Connection, Reflection & Introspection, and Trust & Acceptance. NIH-HEALS and a demographic questionnaire were administered to 193 patients with serious and/or life-limiting illness at the National Institutes of Health Clinical Center. Results: In response to NIH-HEALS, men and women significantly differed on the Reflection & Introspection factor. Women reported increased enjoyment of mind-body practices (p < 0.001), compassion (p = 0.005), gratitude (p = 0.014), and a desire to be more positive (p = 0.044) compared to men. Men rated their pain levels (p = 0.035) and severity of illness (p = 0.016) higher and their overall level of health (p = 0.010) poorer compared to women. Women's responses to items regarding compassion (rs = 0.37, p < 0.001) and gratitude (rs = 0.24, p = 0.015) correlated positively with better overall health ratings. Conclusion: Men and women show some differences in their self-reported psycho-social-spiritual healing, which may have implications when designing interventions aimed at promoting a healing experience in the context of serious and life-limiting illness.

The National Institutes of Health measure of Healing Experience of All Life Stressors (NIH-HEALS): Factor analysis and validation.

Two hundred patients with severe and/or life-threatening disease were recruited form the NIH Clinical Center and participated in the validation of the NIH-HEALS, which included exploratory factor analysis, principal component analysis, reliability, convergent validity, and divergent validity analyses. Item-reducing principal components analysis and internal consistency and split-half reliability demonstrated excellent internal consistency and split-half reliability (Cronbach's alpha = 0.89, split-half reliability = 0.95). Exploratory factor analysis revealed a three-factor structure, namely Connection (including religious, spiritual, and interpersonal), Reflection & Introspection, and Trust & Acceptance. Seven items were not retained. Convergent and divergent validity of 35-item NIH-HEALS against other validated measures of healing and spirituality provided strong evidence for its validity. As predicted, the Healed factor of the Self-Integration Scale (SIS), and Meaning, Peace, and Faith factors of the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being-12 Scale (FACIT-SP12) were all positively and significantly correlated with the NIH-HEALS and its three factors. Divergent validity was also confirmed by the significant negative correlation between the NIH-HEALS and the Codependent factor on the SIS. Confirmatory Factor Analyses revealed good model fit by GFI (0.96), adjusted GFI (0.95), SRMR (0.077), and RMSEA (0.065), supporting the use of the NIH-HEALS with 35 items.

Long-term treatment of 12 children with chronic hypoparathyroidism: a randomized trial comparing synthetic human parathyroid hormone 1-34 versus calcitriol and calcium.

CONTEXT: Hypoparathyroidism is among the few hormonal insufficiency states not treated with replacement of the missing hormone. This is the first randomized controlled study in children comparing treatment with synthetic human PTH 1-34 and calcitriol. OBJECTIVE: The primary objective was to assess the efficacy and safety of long-term PTH 1-34 vs. calcitriol treatment in the maintenance of normal serum calcium values and renal calcium excretion in children with hypoparathyroidism. SETTING: The study was conducted at a clinical research center. SUBJECTS: Subjects included 12 children aged 5-14 yr with chronic hypoparathyroidism and without severe renal or hepatic insufficiency. STUDY DESIGN: The study was a 3-yr randomized parallel trial comparing twice-daily calcitriol (plus calcium and cholecalciferol in four daily doses) vs. s.c. PTH 1-34 treatment, with weekly or biweekly monitoring of serum and urine calcium. RESULTS: Mean predose serum calcium levels were maintained at, or just below, the normal range, and urine calcium levels remained in the normal range throughout the 3-yr study, with no significant differences between treatment groups. Creatinine clearance, corrected for body surface area, did not differ between groups and remained normal throughout the study. Markers of bone turnover were mildly elevated during PTH 1-34 therapy and remained within the normal range during calcitriol therapy. Mean bone mineral density Z-scores at the anterior-posterior lumbar spine, femoral neck, distal radius, and whole body remained within the normal range and did not differ between groups throughout the study. Similarly, height and weight percentiles did not differ between treatment groups and remained normal throughout the 3-yr follow-up. CONCLUSION: We conclude that PTH 1-34 therapy is safe and effective in maintaining stable calcium homeostasis in children with hypoparathyroidism. Additionally, PTH 1-34 treatment allowed normal skeletal development because there were no differences in bone mineral accrual, linear growth, or weight gain between the two treatment arms over the 3-yr study period.

Effects of once versus twice-daily parathyroid hormone 1-34 therapy in children with hypoparathyroidism.

CONTEXT: Hypoparathyroidism is among the few hormonal insufficiency states not treated with replacement of the missing hormone. Long-term conventional therapy with vitamin D and analogs may lead to nephrocalcinosis and renal insufficiency. OBJECTIVE: Our objective was to compare the response of once-daily vs. twice-daily PTH 1-34 treatment in children with hypoparathyroidism. SETTING: The study was conducted at a clinical research center. SUBJECTS: Fourteen children ages 4-17 yr with chronic hypoparathyroidism were studied. STUDY DESIGN: This was a randomized cross-over trial, lasting 28 wk, which compared two dose regimens, once-daily vs. twice-daily PTH1-34. Each 14-wk study arm was divided into a 2-wk inpatient dose-adjustment phase and a 12-wk outpatient phase. RESULTS: Mean predose serum calcium was maintained at levels just below the normal range. Repeated serum measures over a 24-h period showed that twice-daily PTH 1-34 increased serum calcium and magnesium levels more effectively than a once-daily dose. This was especially evident during the second half of the day (12-24 h). PTH 1-34 normalized mean 24-h urine calcium excretion on both treatment schedules. This was achieved with half the PTH 1-34 dose during the twice-daily regimen compared with the once-daily regimen (twice-daily, 25 +/-15 microg/d vs. once-daily, 58 +/- 28 microg/d; P < 0.001). CONCLUSIONS: We conclude that a twice-daily PTH 1-34 regimen provides a more effective treatment of hypoparathyroidism compared with once-daily treatment because it reduces the variation in serum calcium levels and accomplishes this at a lower total daily PTH 1-34 dose. The results showed, as in the previous study of adult patients with hypoparathyroidism, that a twice-daily regimen produced significantly improved metabolic control compared with once-daily PTH 1-34.

Treatment utilization for endometriosis symptoms: a cross-sectional survey study of lifetime experience.

OBJECTIVE: To examine the lifetime utilization and perceived benefit of medical treatments and surgical procedures for endometriosis-related symptoms. DESIGN: Cross-sectional study of self-reported survey data. SETTING: Academic research setting. PATIENT(S): Self-reported surgically diagnosed endometriosis by 1,160 women responding to the 1998 Endometriosis Association survey. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Use, perceived helpfulness, and outcomes of medical treatments and surgical procedures. RESULT(S): Ninety-five percent of respondents reported pelvic pain, had endured symptoms on average of 16 years, and were young (mean: 36 years), white, and educated. Many women (46%) had tried three or more medical treatments, and almost 20% took them for 10+ years. Many reported medical treatments as helpful for symptoms (range, 36.4%-61.9%), but some reported stopping because of ineffectiveness (range, 15.6%-26.1%) or side effects (range, 10.0%-43.5%). Danazol or medroxyprogesterone acetate (MPA) was most commonly stopped because of side effects (range, 40.7%-43.5%). Surgical procedures were performed at least three times on 42%. Nearly 20% had a hysterectomy or oophorectomy; these procedures were reported as most successful in improving symptoms (45.9% and 37.8%, respectively). CONCLUSION(S): Despite reporting various treatments as helpful, women used many different types and endured symptoms for an average of almost two decades, indicating the profound effect of endometriosis on women's health.