A randomized controlled trial of a close monitoring program for minor depression and distress.
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ABSTRACT:
SUBMITTER: Ross JT
PROVIDER: S-EPMC2518035 | biostudies-other | 2008 Sep
REPOSITORIES: biostudies-other
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Project description:BACKGROUND:Despite evidence on efficacious interventions, a great proportion of depressed adolescents do not receive evidence-based treatment and have no access to specialized mental health care. Remote collaborative depression care (RCDC) may help to reduce the gap between needs and specialized mental health services. OBJECTIVE:The objective of this study was to assess the feasibility, acceptability, and effectiveness of an RCDC intervention for adolescents with major depressive disorder (MDD) living in the Araucanía Region, Chile. METHODS:A cluster randomized, assessor-blind trial was carried out at 16 primary care centers in the Araucanía Region, Chile. Before randomization, all participating primary care teams were trained in clinical guidelines for the treatment of adolescent depression. Adolescents (N=143; 13-19 years) with MDD were recruited. The intervention group (RCDC, N=65) received a 3-month RCDC treatment that included continuous remote supervision by psychiatrists located in Santiago, Chile's capital city, through shared electronic health records (SEHR) and phone patient monitoring. The control group (enhanced usual care or EUC; N=78) received EUC by clinicians who were encouraged to follow clinical guidelines. Recruitment and response rates and the use of the SEHR system were registered; patient adherence and satisfaction with the treatment and clinician satisfaction with RCDC were assessed at 12-week follow-up; and depressive symptoms and health-related quality of life (HRQoL) were evaluated at baseline and 12-weeks follow-up. RESULTS:More than 60.3% (143/237) of the original estimated sample size was recruited, and a response rate of 90.9% (130/143) was achieved at 12-week follow-up. A mean (SD) of 3.5 (4.0) messages per patient were written on the SEHR system by primary care teams. A third of the patients showed an optimal adherence to psychopharmacological treatment, and adolescents in the RCDC intervention group were more satisfied with psychological assistance than those in EUC group. Primary care clinicians were satisfied with the RCDC intervention, valuing its usefulness. There were no significant differences in depressive symptoms or HRQoL between groups. Satisfaction with psychological care, in both groups, was related to a significant change in depressive symptomatology at 12-weeks follow-up (beta=-4.3, 95% CI -7.2 to -1.3). CONCLUSIONS:This is the first trial of its kind in Latin America that includes adolescents from vulnerable backgrounds, with an intervention that proved to be feasible and well accepted by both patients and primary care clinicians. Design and implementation issues may explain similar effectiveness across arms. The effectiveness of the intervention seems to be comparable with an already nationwide established treatment program that proved to be highly efficacious under controlled conditions. TRIAL REGISTRATION:ClinicalTrials.gov: NCT01860443; https://clinicaltrials.gov/ct2/show/NCT01860443 (Archived by WebCite at http://www.webcitation.org/6wafMKlTY).
| S-EPMC5812981 | biostudies-literature
Project description:BackgroundDepression is a common mental health problem with significant personal and social consequences. Studies have suggested that cognitive behavioral therapy (CBT) is an effective treatment for depression and anxiety when delivered one-to-one by an expert practitioner, but access to this talking therapy is often limited, and waiting lists can be long. However, a range of low-intensity interventions that can increase access to services are available including guided CBT self-help materials delivered via books, classes, and online packages.ObjectiveThis project aimed to pilot a randomized controlled trial (RCT) of an online CBT-based life skills course with community-based individuals experiencing depression.MethodsIndividuals with symptoms of depression were recruited directly from the community via newspaper advertisements. Participants were remotely randomized to receive either immediate access (IA) or delayed access (DA) to a research version of the Living Life to the Full online CBT-based life skills package (3rd edition) with telephone support provided by nonspecialist, charity-based workers while they used the online intervention. The primary end point was at 3 months postrandomization, at which point, the DA group were offered the intervention. Levels of depression, anxiety, social functioning, and satisfaction were assessed.ResultsThere were effective recruitment, randomization, and uptake, with 19 IA and 17 DA control participants entering the pilot study via newspaper advertisements and 13 of the 19 participants taking up the intervention. Overall, 72% (26/36) were not currently under the care of their general practitioner. The online package was acceptable to participants; the mean satisfaction score on the Client Satisfaction Questionnaire was 21 out of 32 (SD 8.89). At 3 months, data collection was achieved from 78% (28/36) of the participants. The efficacy and retention data were used for a power calculation indicating that 72 participants in total will be required for a future substantive RCT.ConclusionsThe research design successfully tested the recruitment, data collection, and intervention delivery. The pilot study has provided data for the required sample size for the full RCT.Trial registrationISRCTN registry ISRCTN12890709; https://doi.org/10.1186/ISRCTN12890709.International registered report identifier (irrid)RR2-10.1186/s13063-016-1336-y.
| S-EPMC8895278 | biostudies-literature
Project description:ObjectivesTo assess the efficacy of an acute multidisciplinary group intervention on self-perceived recovery following minor traffic-related musculoskeletal injuries.DesignOpen, randomized controlled trial.SettingA large inner-city hospital.Participants127 patients (> or = 15 y) with traffic-related acute minor musculoskeletal injuries and predicted to be at risk for delayed recovery were randomized into an intervention group (n = 65) or a control group (n = 62).InterventionFour 1 1/2-h sessions in open groups with the aim of providing information about injuries in general, calling attention to the importance of self-care and promoting physical activity. In addition, both groups received standard medical care by regular staff.Outcome measuresThe main outcome measure was self-reported recovery at 12 mo. Secondary outcome measures were ratings of functional health status (SF-36, SMFA), pain and mental distress on visual analog scales, and self-reported duration of sick leave.ResultsAt 12 mo, there was a 21.9 percentage point difference: 52.4% of the patients in the intervention group and 30.5% in the control group reported self-perceived recovery (95% confidence interval for the difference 5%-38%; p = 0.03). There were no statistically significant differences between the groups regarding the secondary outcome measures.ConclusionA simple group intervention may accelerate the self-perceived recovery in selected patients. As we did not find evidence of improvements in the secondary outcome measures, the clinical significance of the treatment benefit remains to be defined.
| S-EPMC1829405 | biostudies-literature
Project description:The stepped-care approach, where people with early symptoms of depression are stepped up from low-intensity interventions to higher-level interventions as needed, has the potential to assist many people with mild depressive symptoms. Self-monitoring techniques assist people to understand their mental health symptoms by increasing their emotional self-awareness (ESA) and can be easily distributed on mobile phones at low cost. Increasing ESA is an important first step in psychotherapy and has the potential to intervene before mild depressive symptoms progress to major depressive disorder. In this secondary analysis we examined a mobile phone self-monitoring tool used by young people experiencing mild or more depressive symptoms to investigate the relationships between self-monitoring, ESA, and depression.We tested two main hypotheses: (1) people who monitored their mood, stress, and coping strategies would have increased ESA from pretest to 6-week follow-up compared with an attention comparison group, and (2) an increase in ESA would predict a decrease in depressive symptoms.We recruited patients aged 14 to 24 years from rural and metropolitan general practices. Eligible participants were identified as having mild or more mental health concerns by their general practitioner. Participants were randomly assigned to either the intervention group (where mood, stress, and daily activities were monitored) or the attention comparison group (where only daily activities were monitored), and both groups self-monitored for 2 to 4 weeks. Randomization was carried out electronically via random seed generation, by an in-house computer programmer; therefore, general practitioners, participants, and researchers were blinded to group allocation at randomization. Participants completed pretest, posttest, and 6-week follow-up measures of the Depression Anxiety Stress Scale and the ESA Scale. We estimated a parallel process latent growth curve model (LGCM) using Mplus to test the indirect effect of the intervention on depressive symptoms via the mediator ESA, and calculated 95% bias-corrected bootstrapping confidence intervals (CIs).Of the 163 participants assessed for eligibility, 118 were randomly assigned and 114 were included in analyses (68 in the intervention group and 46 in the comparison group). A parallel process LGCM estimated the indirect effect of the intervention on depressive symptoms via ESA and was shown to be statistically significant based on the 95% bias-corrected bootstrapping CIs not containing zero (-6.366 to -0.029). The proportion of the maximum possible indirect effect estimated was ?(2 )=.54 (95% CI .426-.640).This study supported the hypothesis that self-monitoring increases ESA, which in turn decreases depressive symptoms for young people with mild or more depressive symptoms. Mobile phone self-monitoring programs are ideally suited to first-step intervention programs for depression in the stepped-care approach, particularly when ESA is targeted as a mediating factor.ClinicalTrials.gov NCT00794222; http://clinicaltrials.gov/ct2/show/NCT00794222 (Archived by WebCite at http://www.webcitation.org/65lldW34k).
| S-EPMC3414872 | biostudies-literature
Project description:BACKGROUND:The prevalence of elevated depressive symptoms among youth in most western societies is high. Yet, most adolescents who are experiencing depressive symptoms do not seek help. Low mental health literacy, high stigma, and low social support have been shown to hinder help-seeking. A small number of interventions has been developed to target mental health literacy and stigma, but few focus on actual help-seeking and first aid behavior. We have developed a game-based school program called Moving Stories that targets mental health literacy, including knowledge and behavior, and stigma among adolescents, in regard to depression specifically. OBJECTIVE:Our aim is to describe the protocol for a study that will test the effectiveness of the program Moving Stories in a Dutch adolescent sample. We hypothesize that adolescents who participate in the program Moving Stories will have better mental health literacy and less stigma regarding depression compared to adolescents in the nonintervention control group at posttest and at 3- and 6-months follow-up. We also expect a positive change in actual help-seeking and first aid behavior at 3- and 6-months follow-up. METHODS:Moving Stories has been developed by a professional game design company in collaboration with researchers and relevant stakeholders. The effectiveness of Moving Stories will be tested through a randomized controlled trial with two conditions: Moving Stories versus control. Participants will fill in questionnaires at pretest, posttest, and 3- and 6-months follow-up. Our power analysis showed a required sample size of 180 adolescents. RESULTS:Four high schools have agreed to participate with a total of 10 classes. A total of 185 adolescents filled in the pretest questionnaire. The last of the follow-up data was collected in December 2018. CONCLUSIONS:If Moving Stories proves to be effective, it could be implemented as a school-based program to target mental health literacy and stigma regarding depression; this could, in turn, improve early help-seeking in adolescents suffering from depression. TRIAL REGISTRATION:Nederlands Trial Register NTR7033; https://www.trialregister.nl/trial/6855. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11255.
| S-EPMC6437615 | biostudies-other
Project description:Noninvasive ventilation has been proven to be effective strategies for reducing the need for endotracheal ventilation in preterm infant with respiratory distress syndrome (RDS), however the best option needs to be further determined. A single center, paired design, randomized, controlled trial was conducted between Jan 2011 and July 2014. Preterm twins with RDS were included. One of a pair was randomized to NIPPV, while another to NCPAP. Surfactant was administrated as rescue treatment. The primary outcome was the need for endotracheal ventilation. The secondary outcomes were the complications. 143 pairs were randomized and 129 pairs finished the trial. The rates of endotracheal ventilation did not differ significantly between NIPPV and NCPAP groups (11.9% vs 19.6%, P = 0.080). This difference was not observed in the subgroup of infants who received surfactant therapy (11.1% vs 19.7%, P = 0.087). No secondary outcomes also differed significantly between the two groups. NIPPV did not result in a significantly lower incidence of intubation as compared with NCPAP in preterm twins with RDS.
| S-EPMC4585863 | biostudies-other
Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:In primary health care, the work environment can cause high levels of anxiety and depression, triggering relevant expert and individual change. Mindfulness-Based Stress Reduction (MBSR) programs reduce signs of anxiety and depression. The purpose of this sub-analysis of the total project, was to equate the effectiveness of the standard MBSR curriculum with the abbreviated version in minimizing anxiety and depression. This randomized controlled clinical trial enrolled 112 mentors and resident specialists from Family and Community Medicine and Nurses (FCMN), distributed across six teaching units (TU) of the Spanish National Health System (SNHS). Experimental group participants received a MBRS training (abbreviated/standard). Depression and anxiety levels were measured with the Goldberg Anxiety and Depression Scale (GADS) at three different time periods during the analysis: before (pre-test) and after (post-test) participation, as well as 3 months after the completion of intervention. Taking into account the pre-test scores as the covariate, an adjusted analysis of covariance (ANCOVA) showed significant depletion in anxiety and depression in general (F (2.91) = 4.488; p = 0.014; η2 = 0.090) and depression in particular (F (2, 91) = 6.653; p = 0.002; η2 = 0.128 at the post-test visit, maintaining their effects for 3 months (F (2.79) = 3.031; p = 0.050; η2 = 0.071-F (2.79) = 2.874; p = 0.049; η2 = 0.068, respectively), which is associated with the use of a standard training program. The abbreviated training program did not have a significant effect on the level of anxiety and depression. The standard MBSR training program had a positive effect on anxiety and depression and promotes long-lasting effects in tutors and resident practitioners. New research is needed to demonstrate the effectiveness of abbreviated versions of training programs.
| S-EPMC8708843 | biostudies-literature
Project description:ObjectiveWe sought to test our a priori hypothesis that depressed patients with diabetes in practices implementing a depression management program would have a decreased risk of mortality compared with depressed patients with diabetes in usual-care practices.Research design and methodsWe used data from the multisite, practice-randomized, controlled Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT), with patient recruitment from May 1999 to August 2001, supplemented with a search of the National Death Index. Twenty primary care practices participated from the greater metropolitan areas of New York City, New York; Philadelphia, Pennsylvania; and Pittsburgh, Pennsylvania. In all, 584 participants identified though a two-stage, age-stratified (aged 60-74 or >or=75 years) depression screening of randomly sampled patients and classified as depressed with complete information on diabetes status are included in these analyses. Of the 584 participants, 123 (21.2%) reported a history of diabetes. A depression care manager worked with primary care physicians to provide algorithm-based care. Vital status was assessed at 5 years.ResultsAfter a median follow-up of 52.0 months, 110 depressed patients had died. Depressed patients with diabetes in the intervention category were less likely to have died during the 5-year follow-up interval than depressed diabetic patients in usual care after accounting for baseline differences among patients (adjusted hazard ratio 0.49 [95% CI 0.24-0.98]).ConclusionsOlder depressed primary care patients with diabetes in practices implementing depression care management were less likely to die over the course of a 5-year interval than depressed patients with diabetes in usual-care practices.
| S-EPMC2803110 | biostudies-literature
Project description:BackgroundWEB-Based Distress Management Program for Implantable CARdioverter defibrillator Patients (WEBCARE) is a Web-based randomized controlled trial, designed to improve psychological well-being in patients with an implantable cardioverter defibrillator (ICD). As in other Web-based trials, we encountered problems with attrition and adherence.ObjectiveIn the current study, we focus on the patient characteristics, reasons, and motivation of (1) completers, (2) those who quit the intervention, and (3) those who quit the intervention and the study in the treatment arm of WEBCARE.MethodsConsecutive first-time ICD patients from six Dutch referral hospitals were approached for participation. After signing consent and filling in baseline measures, patients were randomized to either the WEBCARE group or the Usual Care group.ResultsThe treatment arm of WEBCARE contained 146 patients. Of these 146, 34 (23.3%) completed the treatment, 88 (60.3%) dropped out of treatment but completed follow-up, and 24 (16.4%) dropped out of treatment and study. Results show no systematic differences in baseline demographic, clinical, or psychological characteristics between groups. A gradual increase in dropout was observed with 83.5% (122/146) completing the first lesson, while only 23.3% (34/146) eventually completed the whole treatment. Reasons most often given by patients for dropout were technical problems with the computer, time constraints, feeling fine, and not needing additional support.ConclusionsCurrent findings underline the importance of focusing on adherence and dropout, as this remains a significant problem in behavioral Web-based trials. Examining possibilities to address barriers indicated by patients might enhance treatment engagement and improve patient outcomes.Trial registrationClinicaltrials.gov: NCT00895700; http://www.clinicaltrials.gov/ct2/show/NCT00895700 (Archived by WebCite at http://www.webcitation.org/6NCop6Htz).
| S-EPMC3961745 | biostudies-literature