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Managed problem solving for antiretroviral therapy adherence: a randomized trial.

ABSTRACT: Adherence to antiretroviral therapy is critical to successful treatment of human immunodeficiency virus (HIV). Few interventions have been demonstrated to improve both adherence and virologic outcomes. We sought to determine whether an intervention derived from problem solving theory, Managed Problem Solving (MAPS), would improve antiretroviral outcomes.We conducted a randomized investigator blind trial of MAPS compared with usual care in HIV-1 infected individuals at 3 HIV clinics in Philadelphia, Pennsylvania. Eligible patients had plasma HIV-1 viral loads greater than 1000 copies/mL and were initiating or changing therapy. Managed Problem Solving consists of 4 in-person and 12 telephone-based meetings with a trained interventionist, then monthly follow-up calls for a year. Primary outcome was medication adherence measured using electronic monitors, summarized as fraction of doses taken quarterly over 1 year. Secondary outcome was undetectable HIV viral load over 1 year. We assessed 218 for eligibility, with 190 eligible and 180 enrolled, 91 randomized to MAPS and 89 to usual care. Fifty-six participants were lost to follow-up: 33 in the MAPS group and 23 in usual care group.In primary intention-to-treat analyses, the odds of being in a higher adherence category was 1.78 (95% CI,1.07-2.96) times greater for MAPS than usual care. In secondary analyses, the odds of an undetectable viral load was 1.48 (95% CI, 0.94-2.31) times greater for MAPS than usual care. In as-treated analyses, the effect of MAPS was stronger for both outcomes. There was neither a difference by prior treatment status nor change in effect over time.Managed Problem Solving is an effective antiretroviral adherence intervention over the first year with a new regimen. It was equally effective at improving adherence in treatment experienced and naïve patients and did not lose effect over time. Implementation of MAPS should be strongly considered where resources are available.clinicaltrials.gov Identifier: NCT00130273.

SUBMITTER: Gross R

PROVIDER: S-EPMC5053821 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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Managed problem solving for antiretroviral therapy adherence: a randomized trial.

Gross Robert R Bellamy Scarlett L SL Chapman Jennifer J Han Xiaoyan X O'Duor Jacqueline J Palmer Steven C SC Houts Peter S PS Coyne James C JC Strom Brian L BL

JAMA internal medicine 20130201 4

<h4>Background</h4>Adherence to antiretroviral therapy is critical to successful treatment of human immunodeficiency virus (HIV). Few interventions have been demonstrated to improve both adherence and virologic outcomes. We sought to determine whether an intervention derived from problem solving theory, Managed Problem Solving (MAPS), would improve antiretroviral outcomes.<h4>Methods</h4>We conducted a randomized investigator blind trial of MAPS compared with usual care in HIV-1 infected individ ...[more]

PMID: 23358784

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Project description:ContextDepression occurs in more than half of patients who have experienced a stroke. Poststroke depression has been shown in numerous studies to be associated with both impaired recovery in activities of daily living and increased mortality. Prevention of depression thus represents a potentially important goal.ObjectiveTo determine whether treatment with escitalopram or problem-solving therapy over the first year following acute stroke will decrease the number of depression cases that develop compared with placebo medication.Design, setting, and participantsA multisite randomized controlled trial for prevention of depression among 176 nondepressed patients was conducted within 3 months following acute stroke from July 9, 2003, to October 1, 2007. The 12-month trial included 3 groups: a double-blind placebo-controlled comparison of escitalopram (n = 59) with placebo (n = 58), and a nonblinded problem-solving therapy group (n = 59).Main outcome measuresThe main outcome measure was the development of major or minor poststroke depression based on symptoms elicited by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) and the diagnostic criteria from DSM-IV for depression due to stroke with major depressive-like episode or minor depression (ie, research criteria).ResultsPatients who received placebo were significantly more likely to develop depression than individuals who received escitalopram (11 major and 2 minor cases of depression [22.4%] vs 3 major and 2 minor cases of depression [8.5%], adjusted hazard ratio [HR], 4.5; 95% confidence interval [CI], 2.4-8.2; P < .001) and also more likely than individuals who received problem-solving therapy (5 major and 2 minor cases of depression [11.9%], adjusted HR, 2.2; 95% CI, 1.4-3.5; P < .001). These results were adjusted for history of mood disorders and remained significant after considering possible confounders such as age, sex, treatment site, and severity of impairment in the model. Using an intention-to-treat conservative method of analyzing the data, which assumed that all 27 patients who did not start randomized treatment would have developed depression, and controlling for prior history of mood disorders, escitalopram was superior to placebo (23.1% vs 34.5%; adjusted HR, 2.2; 95% CI, 1.2-3.9; P = .007), while problem-solving therapy was not significantly better than placebo (30.5% vs 34.5%; adjusted HR, 1.1; 95% CI, 0.8-1.5; P = .51). Adverse events, including all-cause hospitalizations, nausea, and adverse effects associated with escitalopram were not significantly different between the 3 groups.ConclusionsIn this study of nondepressed patients with recent stroke, the use of escitalopram or problem-solving therapy resulted in a significantly lower incidence of depression over 12 months of treatment compared with placebo, but problem-solving therapy did not achieve significant results over placebo using the intention-to-treat conservative method of analysis.Trial registrationclinicaltrials.gov Identifier: NCT00071643.

Project description:IntroductionTo end the HIV epidemic in Philadelphia, implementation of evidence-based practices (EBP) to increase viral suppression and retention in HIV care is critical. Managed problem solving (MAPS), an EBP for antiretroviral therapy adherence, follows a problem-solving approach to empower people living with HIV (PWH) to manage their health. To overcome barriers to care experienced by PWH in Philadelphia, the EBP was adapted to include a focus on care retention and delivery by community health workers (CHWs). The adapted intervention is MAPS+. To maximise the clinical impact and reach of the intervention, evaluation of the effectiveness and implementation of MAPS+ is necessary.Methods and analysisThis manuscript describes the protocol for a stepped-wedge cluster-randomised type 2 hybrid effectiveness-implementation trial in 10 clinics in Philadelphia. This research incorporates innovative approaches to accomplish three objectives: (1) to evaluate the effectiveness of the CHW-led MAPS+ intervention to improve viral suppression and retention in care 1 year after the individual implementation period (N=390 participants), (2) to examine the effect of the menu of implementation strategies on reach and implementation cost and (3) to examine processes, mechanisms, and sustainment of the implementation strategies for MAPS+ (N=56 participants). Due to various factors (eg, COVID-19), protocol modifications have occurred.Ethics and disseminationThe institutional review board (IRB) at the city of Philadelphia serves as the primary IRB; initial approval was granted on 21 December 2020. The University of Pennsylvania and Northwestern University executed reliance agreements. A safety monitoring committee comprised experts in implementation science, biostatistics and infectious diseases oversee this study. This research will offer insights into achieving the goals to end the HIV epidemic in Philadelphia as well as implementation efforts of MAPS+ and other behavioural interventions aimed at increasing medication adherence and retention in care. Dissemination will include deliverables (eg, peer-reviewed manuscripts and lay publications) to reach multiple constituents.Trial registration numberNCT04560621.

Project description:OBJECTIVES:Family caregivers of hospice patients have multiple needs as they try to cope during a stressful time. Translatable interventions effective in improving caregiver outcomes are greatly needed. Our objective was to assess the impact of a problem-solving intervention (called Problem-Solving Intervention to Support Caregivers in End-of-Life Care Settings [PISCES]) to support hospice caregivers on caregiver quality of life and anxiety, and compare its effectiveness delivered face to face and via videoconferencing. DESIGN:In this 4-year randomized clinical trial, caregivers were randomly assigned to a group receiving standard care with added "friendly calls" (attention control [AC] group), a group receiving standard care and PISCES delivered face to face (F2F), or a group receiving standard care and PISCES delivered via videoconferencing (VC). SETTING:Home hospice. PARTICIPANTS:A total of 514 caregivers participated (172 in AC, 171 in F2F, and 171 in VC). Caregivers were predominantly female (75%); mean age was 60.3 years. INTERVENTION:PISCES includes a structured curriculum delivered in three sessions and motivates caregivers to adopt a positive attitude, define problems by obtaining facts, set goals, and generate and evaluate solutions. MEASUREMENTS:Quality of life was measured by the Caregiver Quality of Life Index-Revised; anxiety was measured by the Generalized Anxiety Disorder 7-Item. Other measures included the Caregiver Reaction Assessment scale, demographic data, and an exit interview. RESULTS:Compared with AC, caregivers in the F2F condition had postintervention reduced anxiety (-1.31 [95% confidence interval [CI]?=?-2.11 to .50]; p?=?.004) and improved social (.57 [95% CI?=?.19-.95]; p?=?.01), financial (.57 [95% CI?=?.21-.93]; p?=?.004), and physical quality of life (.53 [95% CI?=?.19-.87]; p?=?.01). There were no differences in caregivers in the VC condition compared with the AC condition. CONCLUSION:The PISCES intervention improves caregiver outcomes and is effective when delivered in person. How to integrate technology to reduce the intervention delivery cost warrants further investigation.

Project description:PURPOSE:Breast cancer (BC) is a risk factor for major depressive disorder (MDD), yet little research has tested the efficacy of different psychotherapies for depressed women with BC. This study, the largest to date, compared outcomes of three evidence-based, 12-week therapies in treating major depressive disorder among women with breast cancer. METHODS:This randomized trial compared interpersonal psychotherapy (IPT), problem solving therapy (PST), and brief supportive psychotherapy (BSP). Conducted at the outpatient clinic of the New York State Psychiatric Institute/Columbia University, the trial offered bilingual treatment by treatment-specific psychotherapists supervised by treatment experts. The primary outcome was change in the Hamilton Depression Rating Scale (HAM-D) at 12 weeks. Secondary outcomes included other validated patient-reported outcomes for depression and quality of life. RESULTS:Of 179 women with breast cancer screening positive for depression at the Columbia Cancer Center, 134 eligible patients signed informed treatment consent. Half of patients were Hispanic and economically disadvantaged. Most women had stage I (35.2%) or II (36.9%) BC; 9% had stage IV. The three brief psychotherapies showed similar improvements on the HAM-D, with large pre-post effect sizes (d?~?1.0); a priori defined response rates were 35% for IPT, 50% for PST and 31% for BSP, and remission rates 25%, 30% and 27%, respectively. The three treatments also showed similar improvements in the Quality of Life Enjoyment and Satisfaction Questionnaire. Dropout was high, ranging from 37 to 52% across treatments. Predictors of dropout included having?<?16 years of education and annual family income <?$20,000. CONCLUSIONS:Among patients who completed treatment, all three psychotherapies were associated with similar, meaningful improvements in depression. Physical distance between the oncology and psychiatric treatment sites might have contributed to high dropout. This study suggests various psychotherapy approaches may benefit patients with breast cancer and major depression.

Project description:BACKGROUND:Individuals with diabetes mellitus have difficulty solving problems in meaningful occupations and have similar difficulties with self-care regimens. We examined the effects of an occupation-based intervention supported with problem-solving therapy in individuals with type 2 diabetes mellitus on participation in and satisfaction with meaningful occupations, diabetes-related psychosocial self-efficacy, preferred coping strategies and individual well-being. METHODS:This study was planned as a single-blind, randomised controlled study with a 3-month follow-up involving 67 adults with type 2 diabetes. The Canadian Occupational Performance Measure, Diabetes Empowerment Scale, Brief COPE and five-item World Health Organisation Well-Being Index were used. This programme included evaluations, diabetes education, and problem-solving therapy. The intervention was conducted for 6 weeks, and each weekly session lasted approximately 60?min. Differences between groups were analysed using the Mann-Whitney U test, and the Friedman test was used to calculate group-time interaction differences (i.e., baseline, after 6 weeks and after 3 months). RESULTS:All participants identified the most significant occupational performance problems in self-care as personal care. Significant improvement was reported in the intervention group compared to the control group regarding participation in meaningful occupation, satisfaction with performance, psychosocial self-efficacy, and well-being results (p?<?0.001) after the programme and 3 months of follow-up. Participant use of effective coping strategies, active coping and acceptance strategies, and self-efficacy, as revealed by the results, suggested improvement in favour of the intervention group (p?<?0.05). CONCLUSIONS:Occupation-based problem-solving therapy encourages participation in meaningful occupations and improves psychosocial self-efficacy, effective coping styles, and well-being in patients with type 2 diabetes mellitus. Problem-solving therapies that incorporate individuals' priorities via meaningful occupation can be used to lead to a meaningful and quality life for individuals with type 2 diabetes mellitus. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03783598 . Retrospectively Registered. First Posted-December 21, 2018, Last Update Posted-February 18, 2020.

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Managed problem solving for antiretroviral therapy adherence: a randomized trial.

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Managed problem solving for antiretroviral therapy adherence: a randomized trial.

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