Effect of Computer-Assisted Cognitive Behavior Therapy vs Usual Care on Depression Among Adults in Primary Care: A Randomized Clinical Trial.
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SUBMITTER: Wright JH
PROVIDER: S-EPMC8832170 | biostudies-literature | 2022 Feb
REPOSITORIES: biostudies-literature
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Effect of Computer-Assisted Cognitive Behavior Therapy vs Usual Care on Depression Among Adults in Primary Care: A Randomized Clinical Trial.
Wright Jesse H JH Owen Jesse J Eells Tracy D TD Antle Becky B Bishop Laura B LB Girdler Renee R Harris Lesley M LM Wright R Brent RB Wells Michael J MJ Gopalraj Rangaraj R Pendleton Michael E ME Ali Shehzad S
JAMA network open 20220201 2
<h4>Importance</h4>Depression is a common disorder that may go untreated or receive suboptimal care in primary care settings. Computer-assisted cognitive behavior therapy (CCBT) has been proposed as a method for improving access to effective psychotherapy, reducing cost, and increasing the convenience and efficiency of treatment for depression.<h4>Objectives</h4>To evaluate whether clinician-supported CCBT is more effective than treatment as usual (TAU) in primary care patients with depression a ...[more]
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Project description:ImportanceApproximately 1 in 5 adults are diagnosed with depression in their lifetime. However, less than half receive help from a health professional, with the treatment gap being worse for individuals with socioeconomic disadvantage. Computer-assisted cognitive behavioral therapy (CCBT) is an effective and convenient strategy to treat depression; however, its cost-effectiveness in a sociodemographically diverse population remains unknown.ObjectiveTo evaluate the cost-effectiveness of clinician-supported CCBT compared with treatment as usual (TAU) in a primary care population with a substantial number of patients with low income, limited computer or internet access, and lack of college education.Design, setting, and participantsThis economic evaluation was a randomized clinical trial-based cost-effectiveness analysis. The trial was conducted at the Departments of Family and Geriatric Medicine and Internal Medicine at the University of Louisville. Enrollment occurred from June 24, 2016, to May 13, 2019. Participants had mild to moderate depression and were followed up for 6 months after treatment completion. The last follow-up assessment was conducted on January 30, 2020. Statistical analysis was performed from August 2023 to August 2024.ExposureCCBT intervention was provided for 12 weeks and included 9 modules ranging from behavioral activation and cognitive restructuring to relapse prevention strategies, supported by telephonic sessions with a clinician, in addition to TAU, which included standard clinical management in primary care.Main outcomes and measuresThe primary health outcome was quality-adjusted life years (QALYs), estimated using the Short-Form 12 questionnaire (SF-12). The secondary outcome was treatment response, defined as at least 50% improvement in the Patient Health Questionnaire. The intervention cost included sessions with mental health clinicians and the cost of the CCBT software, plus the cost of loaner computer and internet data plan for low-resource households. An incremental cost-effectiveness ratio (ICER) was computed, while adjusting for baseline scores, age, and sex. The cost-effectiveness acceptability curve presented the probability of CCBT being cost-effective for a range of willingness-to-pay values.ResultsAmong the 175 primary care patients included in this study, 148 (84.5%) were female; 48 (27.4%) were African American, 2 (1.2%) were American Indian or Alaska Native, 4 (2.5%) were Hispanic, 106 (60.5%) were White, and 15 (8.6%) were multiracial; and the mean (SD) age was 47.03 (13.15) years. CCBT was associated with better quality of life and higher chance of treatment response at the posttreatment and 6-month time points, compared with the TAU group. The ICER for CCBT was $37 295 (95% CI, $22 724-$66 546) per QALY, with a probability of 89.4% of being cost-effective at a willingness-to-pay threshold of $50 000/QALY. The ICER per case of treatment response was $3623 (95% CI, $2617-$5377).Conclusions and relevanceIn this trial-based economic evaluation, CCBT was found to be cost-effective, compared with TAU, in primary care patients with depression. As this study included individuals with low income and with limited internet access who are underrepresented in cost-effectiveness studies, it has important policy implications for addressing unmet needs in sociodemographically diverse populations.
| S-EPMC11565263 | biostudies-literature
Project description:ImportancePostpartum depression (PPD) affects as many as 20% of mothers, yet just 1 in 10 of these women receives evidence-based treatment. The COVID-19 pandemic has increased PPD risk, reduced treatment access, and shifted preferences toward virtual care.ObjectiveTo determine whether an online 1-day cognitive behavioral therapy (CBT)-based workshop added to treatment as usual improves PPD, anxiety, social support, mother-infant relationship quality, and infant temperament more than treatment as usual alone.Design, setting, and participantsThis randomized clinical trial included 403 women with PPD who were recruited across Ontario, Canada, during the COVID-19 pandemic (April 20 to October 4, 2020). Women with Edinburgh Postnatal Depression Scale (EPDS) scores of at least 10 who were 18 years or older and had an infant younger than 12 months were eligible.InterventionsWomen were randomly assigned to receive a live, interactive online 1-day CBT-based workshop delivered by a registered psychotherapist, psychiatrist, or clinical psychology graduate student in addition to treatment as usual (n = 202) or to receive treatment as usual and wait-listed to receive the workshop 12 weeks later (n = 201).Main outcomes and measuresThe primary outcome was change in PPD (EPDS scores) in experimental and wait list control groups 12 weeks after baseline. Secondary outcomes included maternal anxiety (7-item Generalized Anxiety Disorder Questionnaire [GAD-7]), social support (Social Provisions Scale), quality of the mother-infant relationship (Postpartum Bonding Questionnaire), and infant temperament (Infant Behavior Questionnaire-Revised Very Short Form).ResultsParticipants all identified as women with a mean (SD) age of 31.8 (4.4) years. The workshop led to significant mean (SD) reductions in EPDS scores (from 16.47 [4.41] to 11.65 [4.83]; B = -4.82; P < .001) and was associated with a higher odds of exhibiting a clinically significant decrease in EPDS scores (odds ratio, 4.15; 95% CI, 2.66-6.46). The mean (SD) GAD-7 scores decreased from 12.41 (5.12) to 7.97 (5.54) after the workshop (B = -4.44; 95% CI, -5.47 to -3.38; P < .001) and participants were more likely to experience a clinically significant change (odds ratio, 3.09; 95% CI, 1.99-4.81). Mothers also reported improvements in bonding (B = -3.22; 95% CI, -4.72 to -1.71; P < .001), infant-focused anxiety (B = -1.64; 95% CI, -2.25 to 1.00; P < .001), social support (B = 3.31; 95% CI, 1.04 to 5.57; P < .001), and positive affectivity/surgency in infants (B = 0.31; 95% CI, 0.05 to 0.56; P < .001).Conclusions and relevanceIn this randomized clinical trial, an online 1-day CBT-based workshop for PPD provides an effective, brief option for mothers, reducing PPD and anxiety as well as improving social support, the mother-infant relationship, and positive affectivity/surgency in offspring.Trial registrationClinicalTrials.gov Identifier: NCT04485000.
| S-EPMC8427485 | biostudies-literature
Project description:Introduction: Evidence from developed countries shows the efficacy of computer-assisted cognitive-behavioral therapy (cCBT) in addressing adolescent depression in home and/or school settings. This paper presents the results of a randomized controlled trial (RCT) of a brief therapist-guided cCBT intervention for adolescent depression in resource-constrained primary health care (PHC) settings. Material and methods: A multicenter, two-arm parallel-group, individually RCT with a 1:1 allocation ratio assigned 216 depressed adolescents (aged 15-19) attending four PHC centers in a low-income municipality of Santiago, Chile, to receive eight weekly face-to-face therapist-guided cCBT sessions by study therapists (N = 108), or to receive an enhanced usual care (EUC) intervention by trained PHC psychologists, encouraged to adhere to the national clinical guidelines for the management of depression (N = 108). Both groups received pharmacotherapy concordant with these guidelines. The primary outcome was the Beck Depression Inventory (BDI) at 4 months post-randomization, to assess depressive symptoms. BDI at 6 months post-randomization was a secondary outcome. Additional measures included patients' compliance, and satisfaction with different treatment components, at 6 months post-randomization. Main Results: The adjusted difference in mean BDI score between groups was -3.75 (95% CI -6.23 to -1.28; p = 0.003) at 4 months post-randomization. At 6 months post-randomization, the adjusted difference in mean BDI score between groups was -2.31 (95% CI -4.89 to 0.27; p = 0.078). The effect size was small-to-medium at 4 months post-randomization, d = 0.39 (0.12 to 0.67), and small and non-significant at 6 months post-randomization d = 0.29 (-0.00 to 0.59). Adolescents in the experimental treatment group were significantly more satisfied with treatment, with the PHC centers' facilities, with the psychological care received, and with non-professional staff than those in the comparator treatment group. Discussion: A brief therapist-guided cCBT eight-session intervention improves the response of depressed adolescents attending PHC centers at 4 months post-randomization. At 6 months post-randomization, the differences of between groups were not significant. Future research may focus on exploring strategies to sustain and increase response. Clinical trial registration: www.ClinicalTrials.gov, identifier NCT01862913 and URL: https://clinicaltrials.gov/ct2/show/NCT01862913.
| S-EPMC6682617 | biostudies-literature
Project description:BackgroundGoals 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.MethodsVeterans 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.ResultsGEM 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.ConclusionsWe 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 registrationNCT03006328 Retrospectively registered on December 30, 2016.
| S-EPMC6360675 | biostudies-literature
Project description:BackgroundIndividuals with dementia or mild cognitive impairment frequently have multiple chronic conditions (defined as ≥2 chronic medical conditions) and take multiple medications, increasing their risk for adverse outcomes. Deprescribing (reducing or stopping medications for which potential harms outweigh potential benefits) may decrease their risk of adverse outcomes.ObjectiveTo examine the effectiveness of increasing patient and clinician awareness about the potential to deprescribe unnecessary or risky medications among patients with dementia or mild cognitive impairment.Design, setting, and participantsThis pragmatic, patient-centered, 12-month cluster randomized clinical trial was conducted from April 1, 2019, to March 31, 2020, at 18 primary care clinics in a not-for-profit integrated health care delivery system. The study included 3012 adults aged 65 years or older with dementia or mild cognitive impairment who had 1 or more additional chronic medical conditions and were taking 5 or more long-term medications.InterventionsAn educational brochure and a questionnaire on attitudes toward deprescribing were mailed to patients prior to a primary care visit, clinicians were notified about the mailing, and deprescribing tip sheets were distributed to clinicians at monthly clinic meetings.Main outcomes and measuresThe number of prescribed long-term medications and the percentage of individuals prescribed 1 or more potentially inappropriate medications (PIMs). Analysis was performed on an intention-to-treat basis.ResultsThis study comprised 1433 individuals (806 women [56.2%]; mean [SD] age, 80.1 [7.2] years) in 9 intervention clinics and 1579 individuals (874 women [55.4%]; mean [SD] age, 79.9 [7.5] years) in 9 control clinics who met the eligibility criteria. At baseline, both groups were prescribed a similar mean (SD) number of long-term medications (7.0 [2.1] in the intervention group and 7.0 [2.2] in the control group), and a similar proportion of individuals in both groups were taking 1 or more PIMs (437 of 1433 individuals [30.5%] in the intervention group and 467 of 1579 individuals [29.6%] in the control group). At 6 months, the adjusted mean number of long-term medications was similar in the intervention and control groups (6.4 [95% CI, 6.3-6.5] vs 6.5 [95% CI, 6.4-6.6]; P = .14). The estimated percentages of patients in the intervention and control groups taking 1 or more PIMs were similar (17.8% [95% CI, 15.4%-20.5%] vs 20.9% [95% CI, 18.4%-23.6%]; P = .08). In preplanned subgroup analyses, adjusted differences between the intervention and control groups were -0.16 (95% CI, -0.34 to 0.01) for individuals prescribed 7 or more long-term medications at baseline (n = 1434) and -0.03 (95% CI, -0.20 to 0.13) for those prescribed 5 to 6 medications (n = 1578) (P = .28 for interaction; P = .19 for subgroup interaction for PIMs).Conclusions and relevanceThis large-scale educational deprescribing intervention for older adults with cognitive impairment taking 5 or more long-term medications and their primary care clinicians demonstrated small effect sizes and did not significantly reduce the number of long-term medications and PIMs. Such interventions should target older adults taking relatively more medications.Trial registrationClinicalTrials.gov Identifier: NCT03984396.
| S-EPMC8961395 | biostudies-literature
Project description:Depression is a common and disabling condition. In Chile, assistance is guaranteed by law through a national program for depression in primary care services, and there is evidence of effective treatment for depressed women. However, there is a shortage of evidence-based treatments for depression in adolescents. The incorporation of technology to expand therapeutic options is becoming more common. This proposal aims to compare the efficacy of therapy that enhances traditional face-to-face cognitive-behavioral therapy (CBT) with a computer-based program versus usual care to treat depression in adolescents in primary care clinics in Santiago, Chile.This is a two-arm, single-blind, randomized controlled trial with a target enrollment of 216 depressed adolescents between 15 and 19 years of age, attending four primary care clinics in Santiago, Chile. In the active arm, depressed adolescents will receive eight sessions of computer-assisted CBT, led by trained psychologists on a weekly basis. In the control arm, depressed adolescents will receive treatment as usual from the primary care centers. Mean depression scores and indicators of dysfunctional thoughts, problem-solving strategies, and health-related quality of life will be measured at baseline and four and six months after randomization.As far as we know, this is the first randomized controlled trial of a computer-assisted CBT intervention for depressed adolescents in a Latin American country.Clinical Trials: NCT01862913.
| S-EPMC4132907 | biostudies-literature
Project description:ObjectiveThe goal of this study was to explore the feasibility and potential efficacy of providing computer-assisted cognitive behavior therapy (CCBT) after an index course of electroconvulsive therapy (ECT) to prevent relapse.MethodsIn an open-label trial, subjects with major depressive episode who achieved response or remission after an acute treatment with ECT were recruited to enroll in a 9-module CCBT course. Subjects completed the CCBT modules in their own home at their own pace, but were asked to do at least 1 lesson per week, such that all 9 lessons would be completed in the first 2 months. Depression severity and relapse were monitored during the 6 months after ECT.ResultsFifteen subjects (10 responders and 5 remitters) enrolled in the study and logged onto the CCBT course. The mean (SD) number of online lessons completed was 7.6 (1.7) or 84% of the total lessons and the mean (SD) time spent working online was 8.4 (3.9) hours. During the first 2 months (the prescribed time period), the mean (SD) number of lessons completed was 6.5 (1.8), or 72% and the mean (SD) time spent working online was 6.8 (3.2) hours. Of the entire sample of responders and remitters (n = 15), 5 (33%) relapsed at 6 months. Of the 5 remitters, none relapsed during this time period.ConclusionsOur results provide preliminary evidence that CCBT is feasible following ECT. Large controlled trials are needed to definitively assess whether this strategy is efficacious in preventing relapse.
| S-EPMC5315599 | biostudies-literature
Project description:ImportanceAnnual preventive health visits provide an opportunity to screen youths for unhealthy substance use and intervene before serious harm results.ObjectivesTo assess the feasibility and acceptability and estimate the efficacy of a primary care computer-facilitated screening and practitioner-delivered brief intervention (CSBI) system compared with usual care (UC) for youth substance use and associated risk of riding with an impaired driver.Design, setting, and participantsAn intent-to-treat pilot randomized clinical trial compared CSBI with UC among 965 youths aged 12 to 18 years at 5 pediatric primary care offices and 54 practitioners. Patients were randomized to CSBI (n = 628) or usual care (n = 243) groups within practitioner with 12 months of follow-up. Data were collected from February 1, 2015, to December 31, 2017. Data analysis was performed January 1, 2018, to March 30, 2019.InterventionsPatients self-administered a computer-facilitated substance use screening questionnaire before their annual preventive health visits. Immediately after completing the screening, they received their score and level of risk and viewed 10 pages of scientific information and true-life vignettes illustrating health risks associated with substance use. Trained practitioners received the screening results, patients' risk levels, talking points designed to prompt brief counseling, and recommended follow-up plans.Main outcomes and measuresFeasibility and acceptability were assessed using adolescents' postvisit ratings. Days of alcohol use, cannabis use, and heavy episodic drinking were assessed at baseline and 3-, 6-, 9-, and 12-month follow-ups using Timeline Followback, and riding in the past 3 months with a driver who was impaired by use of alcohol or other drugs was assessed using 2 self-report items. The primary outcome was the intervention effect among at-risk youths who reported using alcohol or other drugs in the past 12 months or riding with an impaired driver in the past 3 months at baseline. The secondary outcome was the prevention effect among those with no prior use or risk.ResultsAmong 871 youths screened, 869 completed the baseline assessment; 211 of the 869 reported alcohol or cannabis use in the past 12 months at baseline (mean [SD] age, 16.4 [1.3] years; 114 [54.1%] female; 105 [49.8%] non-Hispanic white). Of the 211 youths, 148 (70.1%) were assigned to the CSBI group and 63 (29.9%) were assigned to the UC group. Among youths in the CSBI group, 105 (70.9%) reported receiving counseling about alcohol, 122 (82.4%) reported receiving counseling about cannabis, and 129 (87.2%) reported receiving counseling about not riding with an impaired driver. Adjusted hazard ratios for time to first postvisit use of alcohol or other drugs for CSBI vs UC were as follows: alcohol use, 0.69 (95% CI, 0.47-1.02); heavy episodic drinking, 0.66 (95% CI, 0.40-1.10); and cannabis use, 0.62 (95% CI, 0.41-0.94). At 12-month follow-ups among 99 youths who reported having ridden in the past 3 months at baseline with an impaired driver (64 in the CSBI group; 35 in the UC group), adjusted relative risk ratio of riding in the past 3 months with an impaired driver for CSBI vs UC groups was 0.58 (95% CI, 0.37-0.91). No intervention effect was observed among youths who reported no prior use of alcohol or other drugs (n = 658) or not having ridden with an impaired driver (n = 769) at baseline.Conclusions and relevanceThe CSBI system is a feasible and acceptable option for screening youths in primary care practice for use of alcohol and other drugs and for risk of riding with an impaired driver, and the estimated efficacy in this sample warrants further testing in larger samples.Trial registrationClinicalTrials.gov identifier: NCT00227877.
| S-EPMC6593643 | biostudies-literature
Project description:BACKGROUND: Early detection of cognitive impairment is a goal of high-quality geriatric medical care, but new approaches are needed to reduce rates of missed cases. OBJECTIVE: To evaluate whether adding routine cognitive screening to primary care visits for older adults increases rates of dementia diagnosis, specialist referral, or prescribing of antidementia medications. SETTING: Four primary care clinics in a university-affiliated primary care network. DESIGN: A quality improvement screening project and quasiexperimental comparison of 2 intervention clinics and 2 control clinics. The Mini-Cog was administered by medical assistants to intervention clinic patients aged 65+ years. Rates of dementia diagnoses, referrals, and medication prescribing were tracked over time using computerized administrative data. RESULTS: Twenty-six medical assistants successfully screened 70% (n = 524) of all eligible patients who made at least 1 clinic visit during the intervention period; 18% screened positive. There were no complaints about workflow interruption. Relative to baseline rates and control clinics, Mini-Cog screening was associated with increased dementia diagnoses, specialist referrals, and prescribing of cognitive enhancing medications. Patients without previous dementia indicators who had a positive Mini-Cog were more likely than all other patients to receive a new dementia diagnosis, specialty referral, or cognitive enhancing medication. However, relevant physician action occurred in only 17% of screen-positive patients. Responses were most related to the lowest Mini-Cog score level (0/5) and advanced age. CONCLUSION: Mini-Cog screening by office staff is feasible in primary care practice and has measurable effects on physician behavior. However, new physician action relevant to dementia was likely to occur only when impairment was severe, and additional efforts are needed to help primary care physicians follow up appropriately on information suggesting cognitive impairment in older patients.
| S-EPMC2219855 | biostudies-other
Project description:ImportanceWhile statin therapy for primary cardiovascular prevention has been associated with reductions in cardiovascular morbidity, the effect on all-cause mortality has been variable. There is little evidence to guide the use of statins for primary prevention in adults 75 years and older.ObjectivesTo examine statin treatment among adults aged 65 to 74 years and 75 years and older when used for primary prevention in the Lipid-Lowering Trial (LLT) component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT).Design, setting, and participantsPost hoc secondary data analyses were conducted of participants 65 years and older without evidence of atherosclerotic cardiovascular disease; 2867 ambulatory adults with hypertension and without baseline atherosclerotic cardiovascular disease were included. The ALLHAT-LLT was conducted from February 1994 to March 2002 at 513 clinical sites.InterventionsPravastatin sodium (40 mg/d) vs usual care (UC).Main outcomes and measuresThe primary outcome in the ALLHAT-LLT was all-cause mortality. Secondary outcomes included cause-specific mortality and nonfatal myocardial infarction or fatal coronary heart disease combined (coronary heart disease events).ResultsThere were 1467 participants (mean [SD] age, 71.3 [5.2] years) in the pravastatin group (48.0% [n = 704] female) and 1400 participants (mean [SD] age, 71.2 [5.2] years) in the UC group (50.8% [n = 711] female). The baseline mean (SD) low-density lipoprotein cholesterol levels were 147.7 (19.8) mg/dL in the pravastatin group and 147.6 (19.4) mg/dL in the UC group; by year 6, the mean (SD) low-density lipoprotein cholesterol levels were 109.1 (35.4) mg/dL in the pravastatin group and 128.8 (27.5) mg/dL in the UC group. At year 6, of the participants assigned to pravastatin, 42 of 253 (16.6%) were not taking any statin; 71.0% in the UC group were not taking any statin. The hazard ratios for all-cause mortality in the pravastatin group vs the UC group were 1.18 (95% CI, 0.97-1.42; P = .09) for all adults 65 years and older, 1.08 (95% CI, 0.85-1.37; P = .55) for adults aged 65 to 74 years, and 1.34 (95% CI, 0.98-1.84; P = .07) for adults 75 years and older. Coronary heart disease event rates were not significantly different among the groups. In multivariable regression, the results remained nonsignificant, and there was no significant interaction between treatment group and age.Conclusions and relevanceNo benefit was found when pravastatin was given for primary prevention to older adults with moderate hyperlipidemia and hypertension, and a nonsignificant direction toward increased all-cause mortality with pravastatin was observed among adults 75 years and older.Trial registrationclinicaltrials.gov Identifier: NCT00000542.
| S-EPMC5543335 | biostudies-literature