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A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial.

ABSTRACT: Health behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk.Eligible patients are adults enrolled in Veterans Affairs (VA) health care who have not experienced a cardiovascular event but are at elevated risk based on their Framingham Risk Score (FRS). Participants in this two-site study are randomized to either the intervention or care as usual, with a target of 400 participants. The study intervention, Healthy Living Problem-Solving (HELPS), consists of six group sessions conducted approximately monthly interspersed with individualized coaching calls to help participants apply problem-solving principles. The primary outcome is FRS, analyzed at the beginning and end of the study intervention (6months). Participants also complete measures of physical activity, caloric intake, self-efficacy, group cohesion, problem-solving capacities, and demographic characteristics.Results of this trial will inform behavioral interventions to change health behaviors in those at risk for cardiovascular disease and other health conditions.ClinicalTrials.gov identifier NCT01838226.

SUBMITTER: Nieuwsma JA

PROVIDER: S-EPMC5579718 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial.

Nieuwsma Jason A JA Wray Laura O LO Voils Corrine I CI Gierisch Jennifer M JM Dundon Margaret M Coffman Cynthia J CJ Jackson George L GL Merwin Rhonda R Vair Christina C Juntilla Karen K White-Clark Courtney C Jeffreys Amy S AS Harris Amy A Owings Michael M Marr Johnpatrick J Edelman David D

Contemporary clinical trials 20170623

<h4>Background</h4>Health behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk.<h4>Methods</h4>Eligible patients are adults enrolled i ...[more]

PMID: 28600161

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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: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.

Project description:BackgroundPsychosocial interventions delivered by nonspecialists can be effective at reducing common adolescent mental health problems in low-resource settings. However, there is a lack of evidence on resource-efficient methods for building capacity to deliver these interventions.ObjectiveThe objective of this study is to evaluate the effects of a digital training (DT) course, delivered in a self-guided format or with coaching, on nonspecialists' competency to deliver a problem-solving intervention intended for adolescents with common mental health problems in India.MethodsWe will conduct a pre-post study with a nested parallel, 2-arm, individually randomized controlled trial. The study aims to recruit 262 participants, randomized 1:1 to receive either a self-guided DT course or a DT course with weekly individualized coaching provided remotely by telephone. In both arms, the DT will be accessed over 4 to 6 weeks. Participants will be nonspecialists (ie, without prior practice-based training in psychological therapies) recruited from among university students and affiliates of nongovernmental organizations in Delhi and Mumbai, India.ResultsOutcomes will be assessed at baseline and 6 weeks post randomization using a knowledge-based competency measure that incorporates a multiple-choice quiz format. The primary hypothesis is that self-guided DT will lead to increased competency scores among novices with no prior experience of delivering psychotherapies. The secondary hypothesis is that digital training with coaching will have an incremental effect on competency scores compared with DT alone. The first participant was enrolled on April 4, 2022.ConclusionsThe study will address an evidence gap on the effectiveness of training methods for nonspecialist providers of adolescent mental health interventions in low-resource settings. The findings from this study will be used to support wider efforts to scale up evidence-based mental health interventions for young people.Trial registrationClinicalTrials.gov NCT05290142; https://clinicaltrials.gov/ct2/show/NCT05290142.International registered report identifier (irrid)DERR1-10.2196/41981.

Project description:BackgroundResources are spent worldwide on the development of digital platforms and their user interfaces (UIs) for digital mental health services (DMHS). However, studies investigating the potential benefits of different UIs for DMHS are currently lacking. To fill this knowledge gap, the aim of this study was to investigate differences in treatment engagement between two different UIs for DMHS.MethodsA total of 397 participants from the Swedish general public were randomized (1:1) to use a self-guided digital problem-solving intervention during one week, either with an optimized UI (N = 198), based on user experience (UX) design principles and with automated features, or a basic UI (N = 199), analogous with a UI used in Swedish regular health care comprising elementary UI features and less automation. Primary outcome measures were self-rated usability, on the System Usability Scale, and treatment credibility, on the Credibility/Expectancy Questionnaire. Secondary outcome measures included behavioral engagement with the intervention.FindingsThere were no significant differences between the UIs in ratings of usability or treatment credibility. However, participants who used the optimized UI were significantly more engaged with the intervention as measured by usage of the intervention at least once (odds ratio 2.54, 95% CI [1.67, 3.85]), total number of generated solutions (mean difference 1.41, 95% CI [0.72, 2.11]), and mean number of generated solutions per initiated problem-solving attempt (mean difference 1.45, 95% CI [1.06, 1.85]). Other findings included participants using the optimized UI rating the intervention as easier to understand, while feeling more overwhelmed, than those using the basic UI.InterpretationOur findings indicate that an optimized UI based on UX design principles, in comparison to a basic UI comprising elementary UI features, do not affect overall self-rated usability or treatment credibility but increases some measures of behavioral engagement with a digital intervention.FundingFunded by the Government of Sweden, Ministry of Health and Social Affairs.

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:ImportanceFew evidence-based treatments are available for Gulf War illness (GWI). Behavioral treatments that target factors known to maintain the disability from GWI, such as problem-solving impairment, may be beneficial. Problem-solving treatment (PST) targets problem-solving impairment and is an evidence-based treatment for other conditions.ObjectiveTo examine the efficacy of PST to reduce disability, problem-solving impairment, and physical symptoms in GWI.Design, setting, and participantsThis multicenter randomized clinical trial conducted in the US Department of Veterans Affairs compared PST with health education in a volunteer sample of 511 Gulf War veterans with GWI and disability (January 1, 2015, to September 1, 2019); outcomes were assessed at 12 weeks and 6 months. Statistical analysis was conducted between January 1, 2019, and December 31, 2020.InterventionsProblem-solving treatment taught skills to improve problem-solving. Health education provided didactic health information. Both were delivered by telephone weekly for 12 weeks.Main outcomes and measuresThe primary outcome was reduction from baseline to 12 weeks in self-report of disability (World Health Organization Disability Assessment Schedule). Secondary outcomes were reductions in self-report of problem-solving impairment and objective problem-solving. Exploratory outcomes were reductions in pain, pain disability, and fatigue.ResultsA total of 268 veterans (mean [SD] age, 52.9 [7.3] years; 88.4% male; 66.8% White) were randomized to PST (n = 135) or health education (n = 133). Most participants completed all 12 sessions of PST (114 of 135 [84.4%]) and health education (120 of 133 [90.2%]). No difference was found between groups in reductions in disability at the end of treatment. Results suggested that PST reduced problem-solving impairment (moderate effect, 0.42; P = .01) and disability at 6 months (moderate effect, 0.39; P = .06) compared with health education.Conclusions and relevanceIn this randomized clinical trial of the efficacy of PST for GWI, no difference was found between groups in reduction in disability at 12 weeks. Problem-solving treatment had high adherence and reduced problem-solving impairment and potentially reduced disability at 6 months compared with health education. These findings should be confirmed in future studies.Trial registrationClinicalTrials.gov Identifier: NCT02161133.

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A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial.

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A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial.

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