Effect of a Mobile Monitoring System vs Usual Care on Depression Symptoms and Psychological Health: A Randomized Clinical Trial.
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PROVIDER: S-EPMC6991269 | biostudies-literature |
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Project description:BackgroundDepression and anxiety frequently coexist with chronic musculoskeletal pain and can negatively impact patients' responses to standard orthopedic treatments. Nevertheless, mental health is not routinely addressed in the orthopedic care setting. If effective, a digital mental health intervention may be a feasible and scalable method of addressing mental health in an orthopedic setting.ObjectiveWe aimed to compare 2-month changes in mental and physical health between orthopedic patients who received a digital mental health intervention in addition to usual orthopedic care, those who received usual orthopedic care only (without a specific mental health intervention), and those who received in-person care with a psychologist as part of their orthopedic treatment plan.MethodsIn this single-center retrospective cohort study involving ancillary analysis of a pilot feasibility study, 2-month self-reported health changes were compared between a cohort of orthopedic patients who received access to a digital mental health intervention (Wysa) and 2 convenience sample comparison cohorts (patients who received usual orthopedic care without a specific mental health intervention and patients who received in-person care with a psychologist as part of their orthopedic treatment plan). All patients were 18 years or older and reported elevated symptoms of depression or anxiety at an orthopedic clinic visit (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression or Anxiety score ≥55). The digital intervention was a multi-component mobile app that used chatbot technology and text-based access to human counselors to provide cognitive behavioral therapy, mindfulness training, and sleep tools, among other features, with an emphasis on behavioral activation and pain acceptance. Outcomes of interest were between-cohort differences in the 2-month longitudinal changes in PROMIS Depression and Anxiety scores (primary outcomes) and PROMIS Pain Interference and Physical Function scores (secondary outcomes).ResultsAmong 153 patients (mean age 55, SD 15 years; 128 [83.7%] female; 51 patients per cohort), patients who received the digital mental health intervention showed clinically meaningful improvements at the 2-month follow-up for all PROMIS measures (mean longitudinal improvement 2.8-3.7 points; P≤.02). After controlling for age and BMI, the improvements in PROMIS Depression, Pain Interference, and Physical Function were meaningfully greater than longitudinal changes shown by patients who received usual orthopedic care (mean between-group difference 2.6-4.8 points; P≤.04). Improvements in PROMIS Physical Function were also meaningfully greater than longitudinal changes shown by patients who received in-person psychological counseling (mean between-group difference 2.4 points; P=.04).ConclusionsPatients who received a digital mental health intervention as part of orthopedic care reported greater 2-month mean improvements in depression, pain interference, and physical function than patients who received usual orthopedic care. They also reported a greater mean improvement in physical function and comparable improvements in depression, anxiety, and pain interference compared with orthopedic patients who received in-person psychological counseling.
| S-EPMC9118017 | biostudies-literature
Project description:Importance:Depression symptoms are present in one-third of patients with diabetes, contributing to significant adverse consequences. Population screening of high-risk patients coupled with telephone delivery of evidence-based therapies for comorbid diabetes may address barriers to care. Objective:To evaluate the effectiveness of proactive population screening plus telephone delivery of a collaborative goal-setting intervention among high-risk patients with uncontrolled diabetes and depression. Design, Setting, and Participants:In this randomized clinical trial, 225 participants (intervention [n?=?136] and control [n?=?89]) were enrolled from a regional Veterans Healthcare System serving Southeast Texas from November 1, 2012, through June 24, 2016. Data were gathered at baseline and 6 and 12 months after intervention. Patients selected had uncontrolled diabetes (hemoglobin A1c [HbA1c] >7.5%]) and clinically significant depression (Patient Health Questionnaire-9 scores [PHQ-9] ?10) and were living more than 20 miles from the Veterans Affairs medical center. Data collection was completed on December 6, 2016, and final analyses were completed by January 25, 2018. All analyses were intent to treat. Interventions:Healthy Outcomes Through Patient Empowerment (HOPE) included 9 telephone sessions with 24 trained health care professionals using collaborative goal-setting and behavioral activation methods. The control group received enhanced usual care (EUC) and notification of high-risk status. Main Outcomes and Measures:Change in depression symptoms using PHQ-9 and glycemic control using HbA1c from baseline to 6 months and to 12 months. Secondary analyses evaluated clinically significant responses for these measures. Results:Among 225 participants, 202 (89.8%) were men, the mean (SD) age was 61.9 (8.3) years, 145 (64.4%) were married, and 156 (69.3%) had some education beyond high school. For the overall study, 38 participants (16.9%) were lost to follow-up or withdrew at 6 months and another 21 (9.3%) were lost to follow-up or withdrew at 12 months. Repeated-measures analysis with multiple imputation for missing data assessing the interaction of treatment group (HOPE vs EUC) and time (baseline, 6 months, and 12 months) found no significant improvement in PHQ-9 (?, 1.56; 95% CI, -0.68 to 3.81; P?=?.17) or HbA1c (?, -0.005; 95% CI, -0.73 to 0.72; P?=?.82). Analyses using t test for change from baseline to 12 months showed a HOPE vs EUC between-group mean difference for PHQ-9 of 2.14 (95% CI, 0.18 to 4.10; P?=?.03) and for HbA1c of -0.06% (95% CI, -0.61% to 0.50%; P?=?.83). A secondary analysis of patients experiencing a clinical response found that 52.1% of HOPE participants had clinically significant responses in PHQ-9 at 12 months vs 32.9% in EUC (difference, 0.19; 95% CI, 0.04-0.33; P?=?.01). Conclusions and Relevance:Telephone-delivered, collaborative goal setting produced clinically significant reductions in depression symptoms but not glycemic control among patients who remained engaged at 12 months compared with EUC among a population screened sample of high-risk patients with diabetes and depression. Although the intervention created some lasting effect for depression, additional strategies are needed to maintain engagement of this high-risk population within an interprofessional team approach to primary care. Trial Registration:ClinicalTrials.gov identifier: NCT01572389.
| S-EPMC6686779 | biostudies-literature
Project description:Aims:The prolonged use of benzodiazepines and opioids can lead to an increase in the incidence of withdrawal syndrome. One of the known risk factors is the lack of a sedative-weaning protocol. This study established a sedative-weaning protocol and compared this protocol with the usual care of weaning in high-risk critically ill children. Materials and methods:This was an open-label, randomized controlled trial in a tertiary-care hospital. We recruited children aged 1 month to 18 years who had received intravenous sedative or analgesic drugs for at least 5 days. The exclusion criteria were patients who had already experienced the withdrawal syndrome. We established a weaning protocol. Eligible patients were randomly divided into the protocolized (intervention) and usual care (control) groups. The primary objective was to determine the prevalence of the withdrawal syndrome compared between two groups. Results:Thirty eligible patients were enrolled (19 in the intervention and 11 in the control group). Baseline characteristics were not significantly different between both the groups. The prevalence of the withdrawal syndrome was 84% and 81% of patients in the intervention and control group, respectively. The duration of the initial weaning phase was shorter in the intervention group than in the control group (p value = 0.026). The cumulative dose of morphine solution for rescue therapy in the intervention group was statistically lower than that in the control group (p value = 0.016). Conclusion:The implementation of the sedative-weaning protocol led to a significant reduction in the percentage of withdrawal days and length of intensive care unit stay without any adverse drug reactions. External validation would be needed to validate this protocol. ClinicalTrialsgov identifier:NCT03018977. How to cite this article:Tiacharoen D, Lertbunrian R, Veawpanich J, Suppalarkbunlue N, Anantasit N. Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial. Indian J Crit Care Med 2020;24(6):451-458.
| S-EPMC7435087 | biostudies-literature
Project description:The conflicting recommendations for prostate cancer (PCa) screening and the mixed messages communicated to the public about screening effectiveness make it critical to assist men in making informed decisions.To assess the effectiveness of 2 decision aids in helping men make informed PCa screening decisions.A racially diverse group of male outpatients aged 45 to 70 years from 3 sites were interviewed by telephone at baseline, 1 month, and 13 months, from 2007 through 2011. We conducted intention-to-treat univariate analyses and multivariable linear and logistic regression analyses, adjusting for baseline outcome measures.Random assignment to print-based decision aid (n?=?628), web-based interactive decision aid (n?=?625), or usual care (UC) (n?=?626).Prostate cancer knowledge, decisional conflict, decisional satisfaction, and whether participants underwent PCa screening.Of 4794 eligible men approached, 1893 were randomized. At each follow-up assessment, univariate and multivariable analyses indicated that both decision aids resulted in significantly improved PCa knowledge and reduced decisional conflict compared with UC (all P <.001). At 1 month, the standardized mean difference (Cohen’s d) in knowledge for the web group vs UC was 0.74, and in the print group vs UC, 0.73. Decisional conflict was significantly lower for web vs UC (d?=?0.33) and print vs UC (d?=?0.36). At 13 months, these differences were smaller but remained significant. At 1 month, high satisfaction was reported by significantly more print (60.4%) than web participants (52.2%; P?=?.009) and significantly more web (P?=?.001) and print (P?=?.03) than UC participants (45.5%). At 13 months, differences in the proportion reporting high satisfaction among print (55.7%) compared with UC (49.8%; P?=?.06) and web participants (50.4%; P?=?.10) were not significant. Screening rates at 13 months did not differ significantly among groups.Both decision aids improved participants’ informed decision making about PCa screening up to 13 months later but did not affect actual screening rates. Dissemination of these decision aids may be a valuable public health tool.clinicaltrials.gov Identifier: NCT00196807.
| S-EPMC3992617 | biostudies-literature
Project description:BACKGROUND:Students in need of mental health care face many barriers including cost, location, availability, and stigma. Studies show that computer-assisted therapy and 1 conversational chatbot delivering cognitive behavioral therapy (CBT) offer a less-intensive and more cost-effective alternative for treating depression and anxiety. Although CBT is one of the most effective treatment methods, applying an integrative approach has been linked to equally effective posttreatment improvement. Integrative psychological artificial intelligence (AI) offers a scalable solution as the demand for affordable, convenient, lasting, and secure support grows. OBJECTIVE:This study aimed to assess the feasibility and efficacy of using an integrative psychological AI, Tess, to reduce self-identified symptoms of depression and anxiety in college students. METHODS:In this randomized controlled trial, 75 participants were recruited from 15 universities across the United States. All participants completed Web-based surveys, including the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Scale (GAD-7), and Positive and Negative Affect Scale (PANAS) at baseline and 2 to 4 weeks later (T2). The 2 test groups consisted of 50 participants in total and were randomized to receive unlimited access to Tess for either 2 weeks (n=24) or 4 weeks (n=26). The information-only control group participants (n=24) received an electronic link to the National Institute of Mental Health's (NIMH) eBook on depression among college students and were only granted access to Tess after completion of the study. RESULTS:A sample of 74 participants completed this study with 0% attrition from the test group and less than 1% attrition from the control group (1/24). The average age of participants was 22.9 years, with 70% of participants being female (52/74), mostly Asian (37/74, 51%), and white (32/74, 41%). Group 1 received unlimited access to Tess, with daily check-ins for 2 weeks. Group 2 received unlimited access to Tess with biweekly check-ins for 4 weeks. The information-only control group was provided with an electronic link to the NIMH's eBook. Multivariate analysis of covariance was conducted. We used an alpha level of .05 for all statistical tests. Results revealed a statistically significant difference between the control group and group 1, such that group 1 reported a significant reduction in symptoms of depression as measured by the PHQ-9 (P=.03), whereas those in the control group did not. A statistically significant difference was found between the control group and both test groups 1 and 2 for symptoms of anxiety as measured by the GAD-7. Group 1 (P=.045) and group 2 (P=.02) reported a significant reduction in symptoms of anxiety, whereas the control group did not. A statistically significant difference was found on the PANAS between the control group and group 1 (P=.03) and suggests that Tess did impact scores. CONCLUSIONS:This study offers evidence that AI can serve as a cost-effective and accessible therapeutic agent. Although not designed to appropriate the role of a trained therapist, integrative psychological AI emerges as a feasible option for delivering support. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number: ISRCTN61214172; https://doi.org/10.1186/ISRCTN61214172.
| S-EPMC6315222 | 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:Goals for Eating and Moving (GEM) is a technology-assisted health coaching intervention to improve weight management in primary care at the Veterans Health Administration (VHA) that we designed through prior rigorous formative studies. GEM is integrated within the patient-centered medical home and utilizes student health coach volunteers to counsel patients and encourage participation in VHA's intensive weight management program, MOVE!. The primary aim of this study was to determine the feasibility and acceptability of GEM when compared to Enhanced Usual Care (EUC). Our secondary aim was to test the impact of GEM on weight, diet and physical activity when compared to EUC. Methods:Veterans with a Body Mass Index ?30?kg/m2 or 25-29.9?kg/m2 with comorbidities (n?=?45) were recruited in two phases and randomized to GEM (n?=?22) or EUC (n?=?23). We collected process measures (e.g. number of coaching calls completed, number and types of lifestyle goals, counseling documentation) and qualitative feedback on quality of counseling and acceptability of call duration. We also measured weight and behavioral outcomes. Results:GEM participants reported receiving high quality counseling from health coaches and that call duration and frequency were acceptable. They received 5.9 (SD?=?3.7) of 12 coaching calls on average, and number of coaching calls completed was associated with greater weight loss at 6-months in GEM participants (Spearman Coefficient?=?0.71, p?<?0.001). Four participants from GEM and two from EUC attended the MOVE! program. PCPs completed clinical reminders in 12% of PCP visits with GEM participants. Trends show that GEM participants (n?=?21) tended to lose more weight at 3-, 6-, and 12-months as compared to EUC, but this was not statistically significant. There were no significant differences in diet or physical activity. Conclusions:We found that a technology assisted health coaching intervention delivered within primary care using student health coaches was feasible and acceptable to Veteran patients. This pilot study helped elucidate challenges such as low provider engagement, difficulties with health coach continuity, and low patient attendance in MOVE! which we have addressed and plan to test in future studies. Trial registration:NCT03006328 Retrospectively registered on December 30, 2016.
| S-EPMC6360675 | biostudies-literature
Project description:ImportanceThe incidence rate of neck pain is increasing worldwide, and the disease is associated with a high social burden. Manual therapy has been widely applied in the treatment of neck pain, but a high-quality, pragmatic randomized clinical trial for this treatment has not been conducted to date.ObjectiveThis study aimed to compare the effectiveness of Chuna manual therapy with that of usual care for patients with chronic neck pain.Design, setting, and participantsA multicenter, assessor-blinded, pragmatic, randomized clinical trial was conducted between October 18, 2017, and June 28, 2019. This intention-to-treat analysis included 108 patients with chronic neck pain persisting for at least 3 months; patients were recruited from 5 hospitals in Korea.InterventionsTen sessions (2 sessions per week for 5 weeks) of Chuna manual therapy or usual care (electrotherapy and oral medication) were conducted.Main outcomes and measuresThe main outcome was the difference in visual analog scale (VAS) score for chronic neck pain between baseline and 5 weeks after randomization.ResultsThis randomized clinical trial recruited 108 patients (mean [SD] age, 38.4 [9.3] years; 73 women [67.6%]). Fifty-four patients were allocated to the Chuna therapy group, and 54 received usual care. At 5 weeks after randomization, manual therapy showed statistically superior results compared with usual care in terms of pain (difference in chronic neck pain VAS, 16.8 mm; 95% CI, 10.1-23.5 mm), function (difference in Neck Disability Index, 8.6%; 95% CI, 4.2%-13.1%), and quality of life (difference in the European Quality of Life-5 Dimension 5 Levels (EQ-5D-5L) scores, -0.07 points; 95% CI, -0.11 to -0.02 points). Regarding the 1-year cumulative values measured using area under the curve analyses, superior outcomes were attained in the manual therapy group in terms of the numerical rating scale for chronic neck pain (1.3 points; 95% CI, 0.5-2.0 points), Neck Disability Index (6.7%; 95% CI, 2.5%-10.9%), Neck Pain Questionnaire (7.4%; 95% CI, 2.3%-12.6%), and EQ-5D-5L scores (-0.03 points; -0.07 to 0.00 points).Conclusions and relevanceIn this randomized clinical trial, for patients with chronic neck pain, Chuna manual therapy was more effective than usual care in terms of pain and functional recovery at 5 weeks and 1 year after randomization. These results support the need to consider recommending manual therapies as primary care treatments for chronic neck pain.Trial registrationClinicalTrials.gov identifier: NCT03294785.
| S-EPMC8280970 | biostudies-literature
Project description: Not available
| S-EPMC8564576 | biostudies-literature
Project description:This is a randomized clinical trial to evaluate the use of mobile devices in preventing readmission in patients undergoing major GI cancer operations.
| 2280478 | ecrin-mdr-crc