Protocol for 'Resilient Caregivers': a randomised trial of a resilience-based intervention for psychologically distressed partner caregivers of patients with cancer.
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SUBMITTER: Genter P
PROVIDER: S-EPMC8593729 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundPrevious cognitive behavioral therapies for informal caregivers (ICs) have produced negligible effects. The purpose of this study was to evaluate, in a randomized controlled trial, the efficacy of Emotion Regulation Therapy adapted for caregivers (ERT-C) on psychological and inflammatory outcomes in psychologically distressed ICs and the cancer patients cared for.MethodsA total of 81 ICs with elevated psychological distress were randomly assigned to ERT-C or a waitlist condition and assessed pre-, mid-, and post-treatment. In 52 cases, the patient cared for by the IC was included. Patients did not receive ERT-C. Both the ERT-C and waitlist groups were followed 3 and 6 months post-treatment. Data were analyzed with multilevel models, and P values were two-sided.ResultsCompared with ICs in the waitlist condition, ICs in the ERT-C condition experienced medium to large statistically significant reductions in psychological distress (Hedge's g = 0.86, 95% confidence interval [CI] = 0.40 to 1.32, P < .001), worry (g = 0.96, 95% CI = 0.50 to 1.42, P < .001), and caregiver burden (g = 0.53, 95% CI = 0.10 to 1.99, P = .007) post-treatment. No statistically significant effects were found for rumination (g = 0.24, 95% CI = -0.20 to 0.68, P = .220). Results concerning caregiver burden were maintained through 6 months follow-up. Although the effects on psychological distress and worry diminished, their end-point effects remained medium to large. No statistically significant effects on systemic inflammation were detected (C-reactive protein: g = .17, 95% CI = -0.27 to 0.61, P = .570; interleukin-6: g = .35, 95% CI = -0.09 to 0.79, P = .205; tumor necrosis factor-alpha: g = .11, 95% CI = -0.33 to 0.55, P = .686). Patients whose ICs attended ERT-C experienced a large increase in quality of life post-treatment (g = 0.88, 95% CI = 0.18 to 1.58, P = .017).ConclusionsTo our knowledge, this is the first randomized controlled trial evaluating the efficacy of ERT-C for ICs. Given the previous disappointing effects of other cognitive behavioral therapies for this population, the present findings are very encouraging. Identifying ICs with elevated psychological distress and providing them with relevant psychotherapy appears an important element of comprehensive cancer care.
| S-EPMC7050163 | biostudies-literature
Project description:Background. The aim of this randomized, controlled study was to investigate the effectiveness of a mindful walking program in patients with high levels of perceived psychological distress. Methods. Participants aged between 18 and 65 years with moderate to high levels of perceived psychological distress were randomized to 8 sessions of mindful walking in 4 weeks (each 40 minutes walking, 10 minutes mindful walking, 10 minutes discussion) or to no study intervention (waiting group). Primary outcome parameter was the difference to baseline on Cohen's Perceived Stress Scale (CPSS) after 4 weeks between intervention and control. Results. Seventy-four participants were randomized in the study; 36 (32 female, 52.3 ± 8.6 years) were allocated to the intervention and 38 (35 female, 49.5 ± 8.8 years) to the control group. Adjusted CPSS differences after 4 weeks were -8.8 [95% CI: -10.8; -6.8] (mean 24.2 [22.2; 26.2]) in the intervention group and -1.0 [-2.9; 0.9] (mean 32.0 [30.1; 33.9]) in the control group, resulting in a highly significant group difference (P < 0.001). Conclusion. Patients participating in a mindful walking program showed reduced psychological stress symptoms and improved quality of life compared to no study intervention. Further studies should include an active treatment group and a long-term follow-up.
| S-EPMC3747483 | biostudies-literature
Project description:Background and objectivesEmotion differentiation is considered adaptive because differentiated emotional experiences are believed to promote access to the information that emotions carry, enabling context-appropriate emotion regulation. In the present study, secondary analyses from a recent randomized controlled trial (O'Toole et al., 2019) were conducted to investigate whether emotion differentiation can improve as a result of psychotherapy and whether improvements in emotion differentiation are associated with reduced distress.Design and methodsA total of 81 distressed caregivers of cancer patients were randomized to Emotion Regulation Therapy (ERT), an intervention aimed at improving emotion differentiation and facilitating healthy emotion regulation, or a waitlist condition. Emotion differentiation scores could be calculated for 54 caregivers.ResultsRepeated measures ANOVAs revealed that ERT led to significant improvements in negative (η2 = 0.21, p = .012), but not positive emotion differentiation (η2 = <0.01, p = .973). Correlation analyses showed that improvements in negative emotion differentiation were not associated with changes in distress.ConclusionsThe results suggest that negative emotion differentiation can improve as a result of psychotherapy. Further research is needed to clarify how improvements in emotion differentiation following therapeutic interventions relate to treatment outcomes such as distress.Trial registration: ClinicalTrials.gov identifier: NCT02322905.
| S-EPMC8364870 | biostudies-literature
Project description:BackgroundBeing an informal caregiver (IC) of a cancer patient is often associated with psychological distress. We have recently, in a randomized controlled trial (RCT), demonstrated efficacy of Emotion Regulation Therapy for ICs (ERT-C), evidenced as lower levels of psychological distress. Such efficacy demonstration is important, but a crucial step in improving treatments for the IC population is the identification of moderators (i.e., for whom the treatment works) and mediators (i.e., the drivers of the detected effect).Material and methodsIn a sample of 65 psychologically distressed ICs (combining participants who received immediate and delayed treatment in the RCT); we investigated age, gender, and homework completion as moderators of treatment outcome. Proposed mediators were derived from the ERT model and included mindfulness, emotion regulation dysfunction, decentering, and cognitive reappraisal.Results and conclusionsThe strongest moderation effect was found for homework completion, predicting improvements on psychological distress. Correlational mediation analyses generally supported the ERT model. However, temporal precedence was only established for the association between decentering and worry, where a bidirectional relation was revealed. Homework thus emerged as an important aspect of ERT-C and, albeit a bidirectional relationship, changes in decentering may precede changes in worry. Future trials should ensure the robustness of these results, hone the specificity of process measures, and further investigate the causal timeline of change.
| S-EPMC9310668 | biostudies-literature
Project description:This randomized controlled trial evaluated the effect of a mindfulness-based mobile health (mHealth) intervention, tailored to the pandemic context, among young adult students (N = 114) with elevated anxiety and/or depressive symptoms during quarantine in China, compared to a time- and attention-matched social support-based mHealth control. At baseline, postintervention (1 month), and 2-month follow-up, participants completed self-reports of primary outcomes (anxiety and depression), secondary outcomes (mindfulness and social support), and emotional suppression as a culturally relevant mechanism of change. Feasibility and acceptability were also evaluated. Using intent-to-treat (ITT) analysis, linear mixed effects models showed that compared to social support mHealth, mindfulness mHealth had a superior effect on anxiety (p = .024, between-group d = 0.72). Both conditions improved on depression (baseline-to-FU ds > 1.10, between-group difference not significant, d = 0.36 favoring mindfulness). There was an interaction of Emotional suppression reduction × Condition in the improvement of anxiety and depression. Further, mindfulness mHealth was demonstrated to be more feasible and acceptable in program engagement, evaluation, skills improvement, and perceived benefit. Retention was high in both conditions (>80%). The difference in self-reported adverse effect was nonsignificant (3.9% in mindfulness and 8.7% in social support). Results of this pilot trial suggest that both mindfulness and social support, delivered via mHealth, show promise in reducing distress among young adults in quarantine, with mindfulness being particularly effective in addressing anxiety. Successful implementation and dissemination of this mHealth intervention approach have the potential for addressing the psychological consequences of the pandemic. (PsycInfo Database Record (c) 2022 APA, all rights reserved).
| S-EPMC8760365 | biostudies-literature
Project description:BackgroundChronic psychological distress is considered today a pandemic due to the modern lifestyle and has been associated with various neurodegenerative, autoimmune, or systemic inflammation-related diseases. Stress is closely related to liver disease exacerbation through the high activity of the endocrine and autonomic nervous systems, and the connection between the development of these pathologies and the physiological effects induced by oxidative stress is not yet completely understood. The use of nootropics, as the cognitive enhancer and antioxidant piracetam, is attractive to repair the oxidative damage. A proteomic approach provides the possibility to obtain an in-depth comprehension of the affected cellular processes and the possible consequences for the body. Therefore, we considered to describe the effect of distress and piracetam on the liver proteome.MethodsWe used a murine model of psychological stress by predatory odor as a distress paradigm. Female Sprague-Dawley rats were distributed into four experimental groups (n = 6 - 7/group) and were exposed or not to the stressor for five days and treated or not with piracetam (600 mg/kg) for six days. We evaluated the liver proteome by one-dimensional sodium dodecyl sulfate-polyacrylamide gel electrophoresis (1D-SDS-PAGE) followed by liquid chromatography-tandem mass spectrometry (GeLC-MS/MS). Besides, we analyzed the activity of liver antioxidant enzymes, the biochemical parameters in plasma and rat behavior.ResultsOur results showed that distress altered a wide range of proteins involved in amino acids metabolism, glucose, and fatty acid mobilization and degradation on the way to produce energy, protein folding, trafficking and degradation, redox metabolism, and its implications in the development of the non-alcoholic fatty liver disease (NAFLD). Piracetam reverted the changes in metabolism caused by distress exposure, and, under physiological conditions, it increased catabolism rate directed towards energy production. These results confirm the possible relationship between chronic psychological stress and the progression of NAFLD, as well as we newly evidenced the controversial beneficial effects of piracetam. Finally, we propose new distress biomarkers in the liver as the protein DJ-1 (PARK7), glutathione peroxidase 1 (GPX), peroxiredoxin-5 (PRDX5), glutaredoxin 5 (GLRX5), and thioredoxin reductase 1 (TXNDR1), and in plasma as biochemical parameters related to kidney function such as urea and blood urea nitrogen (BUN) levels.
| S-EPMC8140599 | biostudies-literature
Project description:BackgroundMany children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice.Methods and designThis paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance care visits at least twice a year, and an asthma action plan. Cost-effectiveness of the intervention was also measured.DiscussionTwenty-two practices (66 physicians) were randomized (11 per treatment group), and 950 families with a child 3-12 years old with persistent asthma were enrolled. A description of the coaching intervention is presented.
| S-EPMC3352109 | biostudies-literature
Project description:Family members, who provide the majority of care for persons with dementia, are especially vulnerable to developing depression. Interventions targeting their depressive symptoms have been proposed but their efficacies vary considerably. It has been suggested that interventions carried out in the home setting and involving both caregivers and care recipients are more efficacious. This study aims to compare the efficacy of a home-based structured exercise programme involving both persons with dementia and their caregivers with nonexercise social contact control in treating depression among caregivers.This is a parallel-group, assessor-blind, randomised controlled trial. A total of 136 caregiver-care-recipient dyads (i.e. 272 participants in total) will be recruited and randomly allocated to either a home-based structured exercise (sitting Tai Chi) group or a social contact control group. The trial comprises a 3-month intervention phase followed by an extended observation phase of another 3 months. All participants will be assessed at baseline, 6th week, 12th week and 24th week. The primary outcome will be the reduction in depression among caregivers as measured by the Hamilton Rating Scale for Depression. The secondary outcomes will be burden, quality of life, cognitive performance and balance ability of the caregivers, as well as the neuropsychiatric symptoms, cognitive function, balance and functional abilities of the persons with dementia. We will also examine whether the brain-derived neurotrophic factor gene modulates mood changes in response to exercise.The findings offer a potential avenue of intervention by providing a low-cost, safe and effective treatment for depression among dementia caregivers, which may in turn also benefit the care recipients.ClinicalTrials.gov Identifier: NCT02132039 , registered on 28 April 2014.
| S-EPMC5031263 | biostudies-literature
Project description:BackgroundSleep disturbance is common and problematic among both patients with cancer and their sleep partner caregivers. Although 70% of the general adult population sleep in the same bed with a significant other, as do adult cancer patients and their spousal/partner caregivers, and one's sleep affect the partner's sleep, existing psychobehavioral interventions have targeted patients' and caregivers' sleep problems independently.MethodsWe developed a new sleep intervention, My Sleep Our Sleep (MSOS), for both adult patients with cancer and their sleep-partner caregivers together. This protocol is to test the feasibility and acceptability as well as to provide preliminary efficacy of the MSOS intervention, which is a dyadic intervention designed to reduce sleep disturbance and improving sleep quality of both adult cancer patients and their sleep-partner caregivers (dyads). The intervention will be delivered weekly for 4 weeks. Questionnaire and daily sleep logs will be collected at baseline (T1) and one-week after conclusion of the intervention (T2). Satisfaction with the intervention will be assessed weekly for 4 weeks.ResultsWe estimate 43 dyads be enrolled (43 patients and 43 sleep-partner caregivers). We expect >75% of eligible and screened dyads will enroll within the enrollment period, >80% of enrolled dyads will complete the intervention, and >80% of participants will report satisfaction across all acceptability measures. We also expect MSOS will reveal a small-to-medium effect on sleep efficiency (primary outcome), overall sleep disturbance, subjective sleep quality, and insomnia severity (secondary outcomes).ConclusionsResults will inform the feasibility and acceptability of conducting a dyadic sleep intervention, and provide preliminary efficacy data to guide further refinement of the intervention content and procedure for adult patients with cancer and their sleep-partner caregivers.Trial registrationNCT04712604 Clinicaltrials.gov.
| S-EPMC9871738 | biostudies-literature
Project description:IntroductionInformal caregivers play a major role in the support and maintenance of community patients with severe psychiatric disorders. A pilot study showed that an individualised brief intervention such as the Ensemble programme leads to significant improvements in psychological health state and optimism.Methods and analysisThis randomised controlled trial aims to compare the efficacy of using Ensemble in improving informal caregivers' psychological health states and the ability to play an active role in their situations with that of support as usual. Improvements on the psychological health global index will be measured three times (T0-pre, T1-post and T3 2 months follow) with standardised questionnaires (the Global Severity Index of Brief Inventory Symptoms, the Life Orientation Test-Revised, the 36-item Medical Outcome Study Short-Form Health Survey and the French Zarit Burden Interview). Differences between groups in post-test and pretest values will be examined using an analysis of covariance for each outcome variable. The severity of illness measured by the Social and Occupational Functioning Assessment Scale will also be collected at T0 and T2 to compare eventual patient improvements. At the end of the programme, the experiences of the 20 patients participating in the Ensemble programme will be evaluated qualitatively.Ethics and disseminationThe research protocol received full authorisation from the Human Research Ethics Committee of the Vaud state, Switzerland. The principal paper will concern the results of the experimental design used to test the Ensemble programme. The research team will prioritise open access publications.Trial registration numberNCT04020497.
| S-EPMC7394301 | biostudies-literature