A randomized clinical trial of alternative stress management interventions in persons with HIV infection.
Ontology highlight
ABSTRACT:
SUBMITTER: McCain NL
PROVIDER: S-EPMC4629773 | biostudies-other | 2008 Jun
REPOSITORIES: biostudies-other
Publications
A randomized clinical trial of alternative stress management interventions in persons with HIV infection.
McCain Nancy L NL Gray D Patricia DP Elswick R K RK Robins Jolynne W JW Tuck Inez I Walter Jeanne M JM Rausch Sarah M SM Ketchum Jessica McKinney JM
Journal of consulting and clinical psychology 20080601 3
Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of three 10-week stress management approaches--cognitive-behavioral relaxation training (RLXN), focused tai chi training (TCHI), and spiritual growth group ...[more]
Similar Datasets
Project description:A regulated stress response is essential for healthy child growth and development trajectories. We conducted a cluster-randomized trial in rural Bangladesh (funded by the Bill & Melinda Gates Foundation, ClinicalTrials.gov NCT01590095) to assess the effects of an integrated nutritional, water, sanitation, and handwashing intervention on child health. We previously reported on the primary outcomes of the trial, linear growth and caregiver-reported diarrhea. Here, we assessed additional prespecified outcomes: physiological stress response, oxidative stress, and DNA methylation (N = 759, ages 1-2 years). Eight neighboring pregnant women were grouped into a study cluster. Eight geographically adjacent clusters were block-randomized into the control or the combined nutrition, water, sanitation, and handwashing (N+WSH) intervention group (receiving nutritional counseling and lipid-based nutrient supplements, chlorinated drinking water, upgraded sanitation, and handwashing with soap). Participants and data collectors were not masked, but analyses were masked. There were 358 children (68 clusters) in the control group and 401 children (63 clusters) in the intervention group. We measured four F2-isoprostanes isomers (iPF(2α)-III; 2,3-dinor-iPF(2α)-III; iPF(2α)-VI; 8,12-iso-iPF(2α)-VI), salivary alpha-amylase and cortisol, and methylation of the glucocorticoid receptor (NR3C1) exon 1F promoter including the NGFI-A binding site. Compared with control, the N+WSH group had lower concentrations of F2-isoprostanes isomers (differences ranging from -0.16 to -0.19 log ng/mg of creatinine, P<0.01), elevated post-stressor cortisol (0.24 log µg/dl; P<0.01), higher cortisol residualized gain scores (0.06 µg/dl; P=0.023), and decreased methylation of the NGFI-A binding site (-0.04; P=0.037). The N+WSH intervention enhanced adaptive responses of the physiological stress system in early childhood.
2024-03-08 | GSE261098 | GEO
Project description:PURPOSE OF REVIEW:The era of modern HIV therapeutics is well underway. The cancer and infectious disease epidemiology of HIV disease has markedly altered as populations are availed to the benefits of antiretroviral therapy (ARV). The types of cancers occurring among those with HIV infection has broadened but the case burden in absolute numbers is very low relative to the background population. There are fewer incident cases of the AIDS-defining cancers (aggressive B-cell lymphomas, Kaposi's sarcoma, and cervical cancer). There is an increased risk for certain non-AIDS-defining cancers, but these occur somewhat sporadically relative to clinical trial enrollment. The changing epidemiology of cancer in HIV poses challenges as well as opportunities for participation of persons with HIV in cancer therapy clinical trials. RECENT FINDINGS:There are excellent examples of cancer trials that inform cancer therapy for patients with HIV infection. Examples include those from HIV-specific trials and from trials mainly focused on the background population that included patients with HIV infection. SUMMARY:Interpretation of clinical trials to guide therapy for those with HIV infection and cancer largely depends on data that does not include HIV-infected patients. The ability to extend clinical trial findings to populations not included in clinical trials remains problematic for a variety of populations, including those with HIV or AIDS. Careful prioritization of studies designed to bridge this gap is needed. However, there are published studies that serve as excellent examples bridging these gaps and the portfolio of cancer therapy trials underway will inform HIV and cancer better than at any time in the past.
| S-EPMC5257291 | biostudies-literature
Project description:BackgroundStress is one of the most common reasons for sick leave. Web-based interventions have the potential to reach an unlimited number of users at a low cost and have been shown to be effective in addressing several health-related problems. Handling stress on an individual level is related to behavior change. To support behavioral changes in stress management, My Stress Control (MSC) was developed. The development of MSC was based on several health psychology theories and models; however, central in the development were Social Cognitive Theory, Theory of Reasoned Action, Theory of Planned Behavior, Transactional Theory of Stress and Coping, and the Transtheoretical Model and Stages of Change. MSC is a fully automated program. The program is tailored to the user's specific needs for stress management and behavior change.ObjectiveIn this study, we aim to conduct a randomized controlled trial to evaluate the extent to which MSC affects perceived stress in persons experiencing work-related stress.MethodsThis was a randomized controlled trial with 2 arms. Study participants were recruited by visiting the worksites and workplace meetings. Participants were assigned to the intervention or wait-list group. Web-based questionnaires were used before and after the intervention to collect data. Perceived stress measured using the Perceived Stress Scale-14 was the primary outcome measurement. Analyses were conducted for both between-group and within-group changes.ResultsA total of 92 participants were included in this study: 48 (52%) in the intervention group and 44 (48%) in the wait-list group. Overall, 25% (12/48) of participants in the intervention group and 43% (19/44) of participants in the wait-list group completed the postintervention assessment. There were no significant effects on perceived stress between the intervention and wait-list groups or within the groups. A small effect size (Cohen d=0.25) was found when comparing mean change over time on the primary outcome measure between the intervention and wait-list groups. In addition, a small effect size was found between pre- and postintervention assessments within the intervention group (Cohen d=0.38) as well as within the wait-list group (Cohen d=0.25).ConclusionsThe effect of MSC on perceived stress remains uncertain. As adherence was low in the intervention group, elements or features that facilitate adherence and engagement must be further developed before firmer conclusions regarding the effect of MSC can be made.Trial registrationClinicalTrials.gov NCT03077568; https://clinicaltrials.gov/ct2/show/NCT03077568.
| S-EPMC8704112 | biostudies-literature
Project description:OBJECTIVE:Evidence links depression and stress to more rapid progression of HIV-1 disease. We conducted a randomized controlled trial to test whether an intervention aimed at improving stress management and emotion regulation, mindfulness-based stress reduction (MBSR), would improve immunological (i.e. CD4+ T-cell counts) and psychological outcomes in persons with HIV-1 infection. METHODS:We randomly assigned participants with HIV-1 infection and CD4 T-cell counts >350?cells/?l who were not on antiretroviral therapy in a 1:1 ratio to either an MBSR group (n?=?89) or an HIV disease self-management skills group (n?=?88). The study was conducted at the University of California at San Francisco. We assessed immunologic (CD4, c-reactive protein, IL-6, and d-dimer) and psychological measures (Beck Depression Inventory for depression, modified Differential Emotions Scale for positive and negative affect, Perceived stress-scale, and mindfulness) at 3, 6 and 12?months after initiation of the intervention; we used multiple imputation to address missing values. RESULTS:We observed statistically significant improvements from baseline to 3-months within the MBSR group in depression, positive and negative affect, perceived stress, and mindfulness; between group differences in change were significantly greater in the MBSR group only for positive affect (per item difference on DES-positive 0.25, 95% CI 0.049, 0.44, p?=?.015). By 12?months the between group difference in positive affect was not statistically significant, although both groups had trends toward improvements compared to baseline in several psychological outcomes that were maintained at 12-months; these improvements were only statistically significant for depression and negative affect in the MBSR group and perceived stress for the control group. The groups did not differ significantly on rates of antiretroviral therapy initiation (MBSR?=?39%, control?=?29%, p?=?.22). After 12?months, the mean decrease in CD4+ T-cell count was 49.6?cells/?l in participants in the MBSR arm, compared to 54.2?cells/?l in the control group, a difference of 4.6?cells favoring the MBSR group (95% CI, -44.6, 53.7, p?=?.85). The between group differences in other immunologic-related outcomes (c-reactive protein, IL-6, HIV-1 viral load, and d-dimer) were not statistically significant at any time point. CONCLUSIONS:MBSR improved positive affect more than an active control arm in the 3?months following the start of the intervention. However, this difference was not maintained over the 12-month follow-up and there were no significant differences in immunologic outcomes between intervention groups. These results emphasize the need for further carefully designed research if we are to translate evidence linking psychological states to immunological outcomes into evidence-based clinical practices.
| S-EPMC7656978 | biostudies-literature
Project description:A pretest-posttest, repeated-measures design was used to evaluate the effects of two stress management interventions on a battery of outcomes derived from a psychoneuroimmunological (PNI) framework. The effects of cognitive-behavioral relaxation training groups (CBSM) and social support groups (SSG) were compared with a WAIT-listed control group on the outcomes of psychosocial functioning, quality of life, neuroendocrine mediation, and somatic health. Participants were 148 individuals (119 men, 29 women), diagnosed with HIV disease; 112 (76%) completing the study groups. Using analysis of covariance, the CBSM group was found to have significantly higher postintervention emotional well-being and total quality-of-life scores than did either the SSG or WAIT groups. SSG participants had significantly lower social/family well-being scores immediately postintervention and lower social support scores after 6 months. The findings point to a pressing need for further, well-controlled research with these common intervention modalities.
| S-EPMC2211370 | biostudies-other
Project description:BACKGROUND:Limited health literacy is a known barrier to medication adherence among people living with HIV. Adherence improvement interventions are urgently needed for this vulnerable population. PURPOSE:This study tested the efficacy of a pictograph-guided adherence skills-building counseling intervention for limited literacy adults living with HIV. METHODS:Men and women living with HIV and receiving antiretroviral therapy (N = 446) who scored <90% correct on a test of functional health literacy were partitioned into marginal and lower literacy groups and randomly allocated to 1 of 3 adherence-counseling conditions: (1) pictograph-guided adherence counseling, (2) standard adherence counseling, or (3) general health improvement counseling. Participants were followed for 9 months postintervention with unannounced pill count adherence and blood plasma viral load as primary end points. RESULTS:Preliminary analyses demonstrated the integrity of the trial and >90% of participants were retained. Generalized estimating equations showed significant interactions between counseling conditions and levels of participant health literacy across outcomes. Participants with marginal health literacy in the pictograph-guided and standard-counseling conditions demonstrated greater adherence and undetectable HIV viral loads compared with general health counseling. In contrast and contrary to hypotheses, participants with lower health literacy skills in the general health improvement counseling demonstrated greater adherence compared with the 2 adherence counseling conditions. CONCLUSIONS:Patients with marginal literacy skills benefit from adherence counseling regardless of pictographic tailoring, and patients with lower literacy skills may require more intensive or provider-directed interventions.
| S-EPMC4279917 | biostudies-literature
Project description:Human immunodeficiency virus (HIV)-positive rural individuals carry a 1.3-times greater risk of a depressive diagnosis than their urban counterparts. This randomized clinical trial tested whether telephone-administered interpersonal psychotherapy (tele-IPT) acutely relieved depressive symptoms in 132 HIV-infected rural persons from 28 states diagnosed with Diagnostic and Statistical Manual of Mental Disorders-IV major depressive disorder (MDD), partially remitted MDD, or dysthymic disorder. Patients were randomized to either 9 sessions of one-on-one tele-IPT (n = 70) or standard care (SC; n = 62). A series of intent-to-treat (ITT), therapy completer, and sensitivity analyses assessed changes in depressive symptoms, interpersonal problems, and social support from pre- to postintervention. Across all analyses, tele-IPT patients reported significantly lower depressive symptoms and interpersonal problems than SC controls; 22% of tele-IPT patients were categorized as a priori "responders" who reported 50% or higher reductions in depressive symptoms compared to only 4% of SC controls in ITT analyses. Brief tele-IPT acutely decreased depressive symptoms and interpersonal problems in depressed rural people living with HIV.
| S-EPMC6201290 | biostudies-literature
Project description:BackgroundFew interventions have been shown to improve retention in human immunodeficiency virus (HIV) care, and none have targeted the hospitalized patient. Peer mentoring has not been rigorously tested.MethodsWe conducted a randomized, controlled clinical trial of a peer mentoring intervention. Eligible adults were hospitalized and were either newly diagnosed with HIV infection or out of care. The intervention included 2 in-person sessions with a volunteer peer mentor while hospitalized, followed by 5 phone calls in the 10 weeks after discharge. The control intervention provided didactic sessions on avoiding HIV transmission on the same schedule. The primary outcome was a composite of retention in care (completed HIV primary care visits within 30 days and between 31 and 180 days after discharge) and viral load (VL) improvement (≥1 log10 decline) 6 months after discharge.ResultsWe enrolled 460 participants in 3 years; 417 were in the modified intent-to-treat analysis. The median age was 42 years; 74% were male; and 67% were non-Hispanic black. Baseline characteristics did not differ between the randomized groups. Twenty-eight percent of the participants in both arms met the primary outcome (P = .94). There were no differences in prespecified secondary outcomes, including retention in care and VL change. Post hoc analyses indicated interactions between the intervention and length of hospitalization and between the intervention and receipt of linkage services before discharge.ConclusionsPeer mentoring did not increase reengagement in outpatient HIV care among hospitalized, out-of-care persons. More intense and system-focused interventions warrant further study.Clinical trials registrationNCT01103856.
| S-EPMC4981755 | biostudies-literature
Project description:BackgroundOf the approximately 1 million people living with multiple sclerosis in the United States, more than half receive informal, unpaid care or support from family or friends (caregivers). These caregivers report high levels of stress, anxiety, and negative emotions. Few researchers have conducted psychoeducational interventions for these caregivers.ObjectiveThis paper presents a protocol for a randomized clinical trial that aims to test the efficacy of two interventions for improving stress, anxiety, depression, and negative emotions for caregivers of persons with multiple sclerosis.MethodsParticipants included any self-identified family or friend caregiver of a person with multiple sclerosis. Data collection began in April 2021 and is expected to continue until November 2021. Participants will be randomized to receive either a website-only or a website-coaching intervention delivered for 6 weeks. Data will be collected at baseline, 6 weeks after baseline (after delivery of intervention), and 6 weeks later.ResultsThe protocol was approved by the institutional review board of the Case Western Reserve University on January 21, 2021 (protocol 20201484). As of May 2021, 66 participants were enrolled.ConclusionsOur findings will have implications for identifying the efficacy of two types of interventions developed for caregivers of persons with multiple sclerosis to reduce negative psychological outcomes associated with caregiving.Trial registrationClinicalTrials.gov NCT04662008; http://clinicaltrials.gov/ct2/show/NCT04662008.International registered report identifier (irrid)DERR1-10.2196/30617.
| S-EPMC8430872 | biostudies-literature
Project description:AimsPersons living with HIV (PLWH) have increased cardiovascular mortality, which may in part be due to differences in the management of acute coronary syndromes (ACS). The purpose of this study was to compare the in-hospital and post-discharge management and outcomes of ACS among persons with and without HIV.Methods and resultsThis was a retrospective cohort study using data from Symphony Health, a data warehouse. All patients admitted between 1 January 2014 and 31 December 2016 with ACS were identified by International Classification of Diseases billing codes. Multivariate logistic regression models were used to examine in-hospital, 30-day and 12-month event rates between groups. A total of 1 125 126 individuals were included, 6612 (0.59%) with HIV. Persons living with HIV were younger (57.4 ± 10.5 vs. 67.4 ± 12.9 years, P< 0.0001) and had more medical comorbidities. Acute coronary syndrome type did not differ significantly with HIV status. Persons living with HIV were less likely to undergo coronary angiography (35.2% vs. 37.2%, adjusted OR 0.87, 95% CI 0.83-0.92, P < 0.0001), and those with both HIV and STEMI underwent fewer drug-eluting stents (60.1% vs. 68.5%, adjusted OR 0.81, 95% CI 0.68-0.96, P = 0.016). Persons living with HIV had higher adjusted rates of inpatient mortality (OR 1.29, 95% CI 1.15-1.44; P < 0.0001), 30-day readmission (OR 1.18, 95% CI 1.09-1.27; P < 0.0001) and 12-month mortality (OR 1.32, 95% CI 1.22-1.44; P < 0.0001). Twelve months following discharge, PLWH filled cardiac medications at lower rates.ConclusionIn a contemporary cohort of persons hospitalized for ACS, PLWH received less guideline-supported interventional and medical therapies and had worse clinical outcomes. Strategies to optimize care are warranted in this unique population.
| S-EPMC8092989 | biostudies-literature