Feasibility of an Internet-based positive psychological intervention for hemodialysis patients with symptoms of depression.
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ABSTRACT:
SUBMITTER: Hernandez R
PROVIDER: S-EPMC7282478 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Positive psychological interventions (PPIs), programs that specifically target positive emotions, cognitions, and behaviors, have been shown to reduce depression and improve other aspects of psychological well-being. However, potential pathways linking PPIs to better outcomes have been under-explored. In this paper, we report the results of a randomized trial of a self-guided online delivered PPI called MARIGOLD (Mobile Affect Regulation Intervention with the Goal of Lowering Depression). Participants with elevated depression were randomized to receive MARIGOLD (n = 539) or an emotion reporting control condition (n = 63). In addition to testing direct effects of the intervention on depressive symptoms, we explored whether positive or negative emotion-operationalized as past day, past week, reactivity, or flexibility-mediated the intervention impact on depression. Results demonstrated that participants in the MARIGOLD condition had reduced depressive symptoms compared to controls and, although the effect did not reach statistical significance, reductions in past day negative emotion appeared to mediate this effect. Contrary to hypotheses, the intervention did not increase positive emotion compared to the control condition. Discussion focuses on the need for future studies to continue investigating the mechanisms of action for PPIs with emphasis on theoretically-based measurement and operationalization of emotion and other potential mediators to maximize the ultimate impact of PPIs on psychological well-being. Clinical Trials registration #NCT02861755.
| S-EPMC10104977 | biostudies-literature
Project description:BackgroundDepression is highly prevalent in individuals on hemodialysis, but it is infrequently identified and remains undertreated. In this paper, we present details of the methodology of a randomized controlled trial (RCT) aimed at testing the feasibility and preliminary efficacy of a 5-week positive psychological intervention in individuals on hemodialysis with comorbid depression delivered using immersive virtual reality (VR) technology.ObjectiveWe aim to describe the protocol and design of the Joviality trial whose main objectives are 2-fold: determine the feasibility of the Joviality VR software through metrics capturing rates of recruitment, refusal, retention, noncompliance, and adherence, as well as end-user feedback; and assess preliminary efficacy for outcomes measures of depressive symptoms, psychological well-being and distress, quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalizations.MethodsThis 2-arm RCT is scheduled to enroll 84 individuals on hemodialysis with comorbid depression from multiple outpatient centers in Chicago, Illinois, United States. Enrollees will be randomized to the following groups: VR-based Joviality positive psychological intervention or sham VR (2D wildlife footage and nature-based settings with inert music presented using a head-mounted display). To be eligible, individuals must be on hemodialysis for at least 3 months, have Beck Depression Inventory-II scores of ≥11 (ie, indicative of mild-to-severe depressive symptoms), be aged ≥21 years, and be fluent in English or Spanish. The Joviality VR software was built using agile design principles and incorporates fully immersive content, digital avatars, and multiplex features of interactability. Targeted skills of the intervention include noticing positive events, positive reappraisal, gratitude, acts of kindness, and mindful or nonjudgmental awareness. The primary outcomes include metrics of feasibility and acceptability, along with preliminary efficacy focused on decreasing symptoms of depression. The secondary and tertiary outcomes include quality of life, treatment adherence, clinical biomarkers, and all-cause hospitalization rates. There are 4 assessment time points: baseline, immediately after the intervention, 3 months after the intervention, and 6 months after the intervention. We hypothesize that depressive symptoms and hemodialysis-related markers of disease will substantially improve in participants randomized to the VR-based Joviality positive psychology treatment arm compared with those in the attention control condition.ResultsThis RCT is funded by the National Institute of Diabetes and Digestive and Kidney Diseases and is scheduled to commence participant recruitment in June 2023.ConclusionsThis trial will be the first to test custom-built VR software to deliver a positive psychological intervention, chairside, in individuals on hemodialysis to reduce symptoms of depression. Within the context of an RCT using an active control arm, if proven effective, VR technology may become a potent tool to deliver mental health programming in clinical populations during their outpatient treatment sessions.Trial registrationClinicalTrials.gov NCT05642364; https://clinicaltrials.gov/ct2/show/NCT05642364.International registered report identifier (irrid)PRR1-10.2196/45100.
| S-EPMC10337327 | biostudies-literature
Project description:Up to 50% of patients undergoing hemodialysis suffer from symptoms of depression and/or anxiety. Access to traditional pharmacotherapies and psychotherapies for depression or anxiety in this patient population has been inadequate. The objective of this study was to investigate the feasibility and effectiveness of brief mindfulness meditation intervention for patients on hemodialysis with depression and anxiety symptoms.This study was a randomized, controlled, assessor-blinded trial conducted in an urban hemodialysis unit. Forty-one patients were randomly assigned to intervention (n=21) and treatment-as-usual (n=20) groups. The intervention group received an 8-week individual chairside meditation intervention lasting 10-15 minutes, three times a week during hemodialysis. Feasibility outcomes were primarily assessed: enrollment rates, intervention completion rates, and intervention tolerability. Symptoms of depression and anxiety were measured using the Patient Health Questionnaire (PHQ-9) and the General Anxiety Disorder-7 (GAD-7).Of those deemed eligible for the study, 67% enrolled (41 of 61). Of the participants randomized to the intervention group, 71% completed the study, with meditation being well tolerated (median rating of 8 of 10 in a Likert scale; interquartile range=10-5 of 10). Barriers to intervention delivery included frequent hemodialysis shift changes, interruptions by staff or alarms, space constraints, fluctuating participant medical status, and participant fatigue. Meditation was associated with subjective benefits but no statistically significant effect on depression scores (change in PHQ-9, -3.0±3.9 in the intervention group versus -2.0±4.7 in controls; P=0.45) or anxiety scores (change in GAD-7, -0.9±4.6 versus -0.8±4.8; P=0.91).On the basis of the results of this study, mindfulness meditation appears to be feasible and well tolerated in patients on hemodialysis with anxiety and depression symptoms. The study did not reveal significant effects of the interventions on depression and anxiety scores.This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2017_10_12_CJASNPodcast_17_12_.mp3.
| S-EPMC5718270 | biostudies-literature
Project description:Positive psychological attributes (eg, optimism) have been associated with a healthier lifestyle and superior medical outcomes in patients with type 2 diabetes; however, there has been minimal study of behavioral interventions that target positive psychological constructs in this population. Accordingly, we developed a novel, telephone-based, 12-week positive psychology intervention and assessed its feasibility and short-term impact in adults with type 2 diabetes and suboptimal health behavior adherence. This was a pilot and feasibility study in adult inpatients and outpatients at an urban academic medical center recruited between December 2013 and December 2014. Adult patients with (1) type 2 diabetes (meeting American Diabetes Association criteria, eg, glycated hemoglobin A1c [HbA1c] > 6.5% or fasting glucose > 126 mg/dL) and (2) suboptimal adherence (score < 15/18 on the Medical Outcomes Study Specific Adherence Scale items for medication, diet, and exercise) were eligible. Participants received a positive psychology manual, completed exercises (eg, writing a gratitude letter, performing acts of kindness), and reviewed these activities by phone with a study trainer over the 12-week study period. Feasibility and acceptability were assessed via exercise completion rates and postexercise ratings of ease/utility on 0-10 Likert scales. Longer-term efficacy was explored by examining changes in psychological states and health behaviors from baseline to 12 weeks using random-effects regression models and estimates of effect size. A total of 15 participants enrolled; 12 participants provided complete baseline and follow-up data and were included in the analyses. Over 90% of these participants completed at least 2 exercises, and 75% completed a majority of the exercises. Participants rated the exercises as helpful (mean = 7.8/10) and easy to complete (mean = 7.1/10), and they reported improvements in optimism, gratitude, depression, anxiety, physical function, self-care, and health behaviors (Cohen d = 0.28-1.00). A positive psychology intervention for suboptimally adherent patients with type 2 diabetes was feasible, acceptable, and associated with broad pre-post psychological and health behavior improvement in a small initial study. Further testing of this promising intervention is warranted. ClinicalTrials.gov identifier: NCT02736084.
| S-EPMC5035810 | biostudies-literature
Project description:BackgroundDepression is a heterogeneous collection of symptoms. Prior meta-analyses using symptom sum scores have shown the Internet intervention, Deprexis, to be an efficacious treatment for depression. However, no prior research has investigated how Deprexis (or any other Internet intervention for depression) impacts specific symptoms of depression. The current study utilizes symptom-level analyses to examine which symptoms are directly, indirectly, or minimally influenced by treatment.MethodsNetwork analysis and mean-level approaches examined which symptoms, assessed by the Quick Inventory of Depression Symptoms, were affected by an 8-week course of Deprexis compared with a waitlist in a nationally recruited sample from the United States (N = 295).ResultsDeprexis directly improved the symptoms of sadness and indecision. Changes in these symptoms, in turn, was associated with a change in early insomnia, middle insomnia, self-dislike, fatigue, anhedonia, suicidality, slowness, and agitation. All of these symptoms (except for agitation and early insomnia) show decreases with Deprexis compared with a waitlist after correcting for multiple comparisons. Six additional symptoms, particularly the somatic symptoms, were not impacted by Deprexis compared with a waitlist.ConclusionsIn this sample, the efficacy of Deprexis was due to its direct impact on sadness and indecision. Examining the treatment-related change in specific symptoms may facilitate a more nuanced understanding of how a treatment works compared with examining symptom sum scores. Symptom-level approaches may also identify symptoms that do not improve and provide important direction for future treatment development.
| S-EPMC6992506 | biostudies-literature
Project description:BACKGROUND:Development of psychosocial group interventions for ovarian cancer survivors has been limited. Drawing from elements of cognitive-behavioral stress management (CBSM), mindfulness-based stress reduction (MBSR), and acceptance and commitment therapy (ACT), we developed and conducted preliminary testing of an Internet-based group intervention tailored specifically to meet the needs of ovarian cancer survivors. The Internet-based platform facilitated home delivery of the psychosocial intervention to a group of cancer survivors for whom attending face-to-face programs could be difficult given their physical limitations and the small number of ovarian cancer survivors at any one treatment site. OBJECTIVE:The aim of this study was to develop, optimize, and assess the usability, acceptability, feasibility, and preliminary intended effects of an Internet-based group stress management intervention for ovarian cancer survivors delivered via a tablet or laptop. METHODS:In total, 9 ovarian cancer survivors provided feedback during usability testing. Subsequently, 19 survivors participated in 5 waves of field testing of the 10-week group intervention led by 2 psychologists. The group met weekly for 2 hours via an Internet-based videoconference platform. Structured interviews and weekly evaluations were used to elicit feedback on the website and intervention content. Before and after the intervention, measures of mood, quality of life (QOL), perceived stress, sleep, and social support were administered. Paired t tests were used to examine changes in psychosocial measures over time. RESULTS:Usability results indicated that participants (n=9) performed basic tablet functions quickly with no errors and performed website functions easily with a low frequency of errors. In the field trial (n=19), across 5 groups, the 10-week intervention was well attended. Perceived stress (P=.03) and ovarian cancer-specific QOL (P=.01) both improved significantly during the course of the intervention. Trends toward decreased distress (P=.18) and greater physical (P=.05) and functional well-being (P=.06) were also observed. Qualitative interviews revealed that the most common obstacles participants experienced were technical issues and the time commitment for practicing the techniques taught in the program. Participants reported that the intervention helped them to overcome a sense of isolation and that they appreciated the ability to participate at home. CONCLUSIONS:An Internet-based group intervention tailored specifically for ovarian cancer survivors is highly usable and acceptable with moderate levels of feasibility. Preliminary psychosocial outcomes indicate decreases in perceived stress and improvements in ovarian cancer-specific QOL following the intervention. A randomized clinical trial is needed to demonstrate the efficacy of this promising intervention for ovarian cancer survivors.
| S-EPMC5789163 | biostudies-literature
Project description:Despite high levels of distress, family caregivers of patients with cancer rarely seek psychosocial support and Internet-based interventions (IBIs) are a promising approach to reduce some access barriers. Therefore, we developed a self-guided IBI for family caregivers of patients with cancer (OAse), which, in addition to patients' spouses, also addresses other family members (e.g., adult children, parents). This study aimed to determine the feasibility of OAse (recruitment, dropout, adherence, participant satisfaction). Secondary outcomes were caregivers' self-efficacy, emotional state, and supportive care needs. N = 41 family caregivers participated in the study (female: 65%), mostly spouses (71%), followed by children (20%), parents (7%), and friends (2%). Recruitment (47%), retention (68%), and adherence rates (76% completed at least 4 of 6 lessons) support the feasibility of OAse. Overall, the results showed a high degree of overall participant satisfaction (96%). There were no significant pre-post differences in secondary outcome criteria, but a trend toward improvement in managing difficult interactions/emotions (p = .06) and depression/anxiety (p = .06). Although the efficacy of the intervention remains to be investigated, our results suggest that OAse can be well implemented in caregivers' daily lives and has the potential to improve family caregivers' coping strategies.
| S-EPMC9537301 | biostudies-literature
Project description:As both of peripheral arterial disease (PAD) and depression carried a poor prognosis in patients on maintenance hemodialysis (MHD), we investigated the correlation between the ankle-brachial index (ABI), an indicator of subclinical PAD, and symptoms of depression in patients on MHD.One hundred and twenty-nine patients on MHD (75 males and 54 females, mean age 64.8 ± 12 years) were enrolled in this cross-sectional study, which aimed at evaluating the relationship between symptoms of depression and ABI. Demographic as well as clinical and laboratory variables including status of diabetes, chronic hepatitis C infection, dialysis duration, Charlson comorbidity index (CCI), plasma levels of albumin, C-peptide, insulin, high-sensitive C-reactive protein (hsCRP), interleukin-6 (IL-6), adiponectin, and lipid profile were obtained. The self-administered beck depression inventory (BDI) was used to determine the presence or absence of symptoms of depression, and depression was defined as a BDI score ≧14. Multivariable-adjusted linear regression models were constructed to confirm the independent association of biologic parameters of symptoms of depression. Significance was defined as P < 0.05. Statistical analyses were performed using SPSS/Windows software (SPSS Science, v. 15.0, Chicago, IL).The mode of multivariate analysis showed that diabetes (β = 3.594; P = 0.040), hepatitis C infection (β = 4.057; P = 0.008), levels of serum albumin (β = -5.656; P = 0.024), C-peptide (β = -0.292; P = 0.002), ABI (β = -9.041; P = 0.031), and Ln-transformed hsCRP were significantly associated with BDI.Hepatitis C infection, serum levels of albumin, C-peptide, and ABI levels were found to be correlated with BDI (P < 0.05).
| S-EPMC5522508 | biostudies-other
Project description:Relapse rates following a depressive episode are high, with limited treatments available aimed at reducing such risk. Acceptance and commitment therapy (ACT) is a cognitive-behavioral approach that has gained increased empirical support in treatment of depression, and thus represents an alternative in relapse prevention. Psychological flexibility (PF) plays an important role in mental health according to the model on which ACT is based. This study aimed to investigate the role of PF and its subprocesses in reducing residual symptoms of depression and in improving positive mental health following an 8-week group-based ACT treatment. Adult participants (75.7% female) with a history of depression, but currently exhibiting residual symptoms (N = 106) completed measures before and after intervention, and at 6 and 12-month follow-up. A growth curve model showed that positive mental health increased over 12-months. Multilevel mediation modeling revealed that PF significantly mediated these changes as well as the reduction of depressive symptoms, and that processes of acceptance, cognitive defusion, values and committed action, in turn, mediated increased PF.
| S-EPMC7119364 | biostudies-literature
Project description:Postpartum depression (PPD)-the most common complication of childbirth-is a significant and prevalent public health problem that severely disrupts family interactions and can result in serious lasting consequences to the health of women and the healthy development of infants. These consequences increase in severity when left untreated; most women with PPD do not obtain help due to a range of logistical and attitudinal barriers.This pilot study was designed to test the feasibility, acceptability, and potential efficacy of an innovative and interactive guided Web-based intervention for postpartum depression, MomMoodBooster (MMB).A sample of 53 women who satisfied eligibility criteria (<9 months postpartum, ?18 years of age, home Internet access and use of personal email, Edinburgh Postnatal Depression Survey score of 12-20 or Patient Health Questionnaire score from 10-19) were invited to use the MMB program. Assessments occurred at screening/pretest, posttest (3 months following enrollment), and at 6 months follow-up.All six sessions of the program were completed by 87% (46/53) of participants. Participants were engaged with the program: visit days (mean 15.2, SD 8.7), number of visits (mean 20.1, SD 12.2), total duration of visits in hours (mean 5.1, SD 1.3), and number of sessions viewed out of six (mean 5.6, SD 1.3) all support high usage. Posttest data were collected from 89% of participants (47/53) and 6-month follow-up data were collected from 87% of participants (46/53). At pretest, 55% (29/53) of participants met PHQ-9 criteria for minor or major depression. At posttest, 90% (26/29) no longer met criteria.These findings support the expanded use and additional testing of the MMB program, including its implementation in a range of clinical and public health settings.
| S-EPMC3841354 | biostudies-literature