Problem adaptation therapy for older adults with major depression and cognitive impairment: a randomized clinical trial.
ABSTRACT: IMPORTANCE:Problem adaptation therapy (PATH) is a treatment for older adults with major depression, cognitive impairment (from mild cognitive deficits to moderate dementia), and disability. Antidepressants have limited efficacy in this population and psychosocial interventions are inadequately investigated. OBJECTIVE:To test the efficacy of 12-week PATH vs supportive therapy for cognitively impaired patients (ST-CI) in reducing depression and disability in 74 older adults with major depression, cognitive impairment, and disability. DESIGN, SETTING, AND PARTICIPANTS:A randomized clinical trial at the Weill Cornell Institute of Geriatric Psychiatry from April 1, 2006, to September 31, 2011. Interventions were administered at the participants' homes. Participants included 74 older individuals (age ? 65 years) with major depression and cognitive impairment to the level of moderate dementia. They were recruited through collaborating community agencies of Weill Cornell Institute of Geriatric Psychiatry and were randomly assigned to 12 weekly sessions of PATH or ST-CI (14.8% attrition rate). INTERVENTIONS:Home-delivered PATH vs home-delivered ST-CI. Problem adaptation therapy integrates a problem-solving approach with compensatory strategies, environmental adaptations, and caregiver participation to improve patients' emotion regulation. Supportive therapy for cognitively impaired patients focuses on expression of affect, understanding, and empathy. MAIN OUTCOMES AND MEASURES:Mixed-effects models for longitudinal data compared the efficacy of PATH with that of ST-CI in reducing depression (Montgomery-Asberg Depression Rating Scale) and disability (World Health Organization Disability Assessment Schedule II) during 12 weeks of treatment. RESULTS:Participants in PATH had significantly greater reduction in depression (Cohen d, 0.60; 95% CI, 0.13-1.06; treatment × time, F(1,179) = 8.03; P =?.005) and disability (Cohen d, 0.67; 95% CI, 0.20-1.14; treatment × time, F(1,169) = 14.86; P =?.001) than ST-CI participants during the 12-week period (primary outcomes). Furthermore, PATH participants had significantly greater depression remission rates than ST-CI participants (37.84% vs 13.51%; ?(2) = 5.74; P =?.02; number needed to treat = 4.11) (secondary outcome). CONCLUSIONS AND RELEVANCE:Problem adaptation therapy was more efficacious than ST-CI in reducing depression and disability. Problem adaptation therapy may provide relief to a large group of depressed and cognitively impaired older adults who have few treatment options. TRIALS REGISTRATION:Clinicaltrials.gov Identifier: NCT00368940.
Project description:OBJECTIVES:Antidepressants have limited efficacy in older adults with depression and cognitive impairment, and psychosocial interventions for this population have been inadequately investigated. Problem Adaptation Therapy (PATH) is a psychosocial intervention for older adults with major depression, cognitive impairment, and disability. DESIGN:This study tests the efficacy of PATH versus Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in reducing depression (Montgamery Asberg Depression Rating Scale [MADRS]) and disability (World Health Organization Disability Assessments Schedule-II [WHODAS-II]) and improving cognitive outcomes (Mini Mental State Examination [MMSE]) over 24 weeks (12 weeks of treatment and 12-week post-treatment follow-up). SETTING:Participants were recruited through collaborating community agencies of Weill Cornell Institute of Geriatric Psychiatry. Both interventions and all research assessments were conducted at home. PARTICIPANTS:Thirty-five older adults (age ? 65 years) with major depression and cognitive impairment no dementia (CIND). INTERVENTIONS:PATH aims to increase emotion regulation by incorporating a problem-solving approach, teaching compensatory strategies, and inviting caregiver participation. Supportive Therapy aims to facilitate the expression of affect, as well as promote empathy. MEASUREMENTS:Depression was measured using the MADRS, disability using the WHODAS-II, and cognition using the MMSE. RESULTS:PATH participants showed significantly greater reduction in MADRS total score (7.04 points at 24 weeks, treatment group by time interaction: F[1,24.4] = 7.61, p = 0.0108), greater improvement in MMSE total score (2.30 points at 24 weeks, treatment group by time interaction: F[1,39.8] = 13.31, p = 0.0008), and greater improvement in WHODAS-II total score (2.95 points at 24 weeks, treatment group by time interaction: F[1,89] = 4.93, p = 0.0290) than ST-CI participants over the 24-week period. CONCLUSIONS:PATH participants had better depression, cognitive, and disability outcomes than ST-CI participants over 6 months. PATH may provide relief to depressed older adults with CIND who currently have limited treatment options.
Project description:OBJECTIVE:To examine the relationship of negative emotions with suicidal ideation during 12 weeks of Problem Adaptation Therapy (PATH) versus Supportive Therapy of Cognitively Impaired Older Adults (ST-CI), hypothesizing that improved negative emotions are associated with reduced suicidal ideation, PATH improves negative emotions more than ST-CI, and improved negative emotions, rather than other depression symptoms, predict reduction in suicidal ideation. METHODS:In a randomized controlled trial of two home-delivered psychosocial interventions, 74 older participants (65-95 years old) with major depressive disorder and cognitive impairment were recruited in collaboration with community agencies. The sample reported less intense feelings than suicidal intention. Interventions and assessments were conducted in participants' homes. PATH focuses on improving emotion regulation, whereas ST-CI focuses on nonspecific therapeutic factors, such as understanding and empathy. Improved negative emotions were measured as improvement in Montgomery Asberg's Depression Rating Scales' (MADRS) observer ratings of sadness, anxiety, guilt, hopelessness, and anhedonia. Suicidal ideation was assessed with the MADRS Suicide Item. RESULTS:MADRS Negative Emotions scores were significantly associated with suicidal ideation during the course of treatment (F[1,165]?=?12.73, p?=?0.0005). PATH participants had significantly greater improvement in MADRS emotions than ST-CI participants (treatment group by time: F[1,63.2]?=?7.02, p?=?0.0102). Finally, improved negative emotions, between lagged and follow-up interview, significantly predicted reduction in suicidal ideation at follow-up interview (F[1, 96]?=?9.95, p?=?0.0022). CONCLUSION:Findings thatimprovement in negative emotions mediates reduction in suicidal ideation may guide the development of psychosocial interventions for reduction of suicidal ideation (clinicaltrials.gov; NCT00368940).
Project description:CONTEXT:Older patients with depression and executive dysfunction represent a population with significant disability and a high likelihood of failing pharmacotherapy. OBJECTIVES:To examine whether problem-solving therapy (PST) reduces disability more than does supportive therapy (ST) in older patients with depression and executive dysfunction and whether this effect is mediated by improvement in depressive symptoms. DESIGN:Randomized controlled trial. SETTING:Weill Cornell Medical College and University of California at San Francisco. PARTICIPANTS:Adults (aged >59 years) with major depression and executive dysfunction recruited between December 2002 and November 2007 and followed up for 36 weeks. Intervention Twelve sessions of PST modified for older depressed adults with executive impairment or ST. Main Outcome Measure Disability as quantified using the 12-item World Health Organization Disability Assessment Schedule II. RESULTS:Of 653 individuals referred to this study, 221 met the inclusion criteria and were randomized to receive PST or ST. Both PST and ST led to comparable improvement in disability in the first 6 weeks of treatment, but a more prominent reduction was noted in PST participants at weeks 9 and 12. The difference between PST and ST was greater in patients with greater cognitive impairment and more previous episodes. Reduction in disability paralleled reduction in depressive symptoms. The therapeutic advantage of PST over ST in reducing depression was, in part, due to greater reduction in disability by PST. Although disability increased during the 24 weeks after the end of treatment, the advantage of PST over ST was retained. CONCLUSIONS:These results suggest that PST is more effective than ST in reducing disability in older patients with major depression and executive dysfunction, and its benefits were retained after the end of treatment. The clinical value of this finding is that PST may be a treatment alternative in an older patient population likely to be resistant to pharmacotherapy. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00052091.
Project description:OBJECTIVE:The study examines the relationship of negative emotions with: 1) non-emotional symptoms (e.g., vegetative and physical symptoms) and 2) the course of depression in suicidal older adults with Major Depressive Disorder (MDD) and cognitive impairment treated with psychotherapy. DESIGN:The authors identified a subgroup of participants (N?=?26) who expressed suicidal ideation at Baseline or Week 12 from a randomized controlled trial (RCT) of two psychosocial interventions, Problem Adaptation Therapy (PATH) and Supportive Therapy for Cognitively Impaired. The authors assessed negative emotions, non-emotional symptoms of depression, depression severity, and suicidal ideation at entry, week 4, week 8, and week 12. PARTICIPANTS:Participants were 65 years and older and had a diagnosis of unipolar depression, varying degrees of cognitive impairment (up to moderate dementia) and suicidal ideation. SETTING:The study was conducted in the Outpatient Department of New York Presbyterian/Weill Cornell Medicine in Westchester, NY. MEASUREMENTS:Negative emotions and non-emotional items were identified with the 24-item Hamilton Depression Rating Scale (Ham-D). RESULTS:Among participants with suicidal ideation, the reduction in negative emotions from baseline to week 4, week 4 to week 8, and week 8 to week 12 was significantly associated with the reduction in non-emotional symptoms of depression at weeks 4, 8, and 12 (F<sub>(1, 35)</sub>?=?6.20, p?=?0.02) and with the reduction in overall depression severity at weeks 4, 8, and 12 (F<sub>(1, 35)</sub>?=?26.63, p <0.0001) after controlling for depression severity at baseline (HAM-D total score) and time trends. CONCLUSION:Our findings may guide the treatment of older patients with depression and suicidal ideation to help reduce depression and suicide risk.
Project description:<h4>Importance</h4>Although problem solving has been an important component of successful depression prevention and treatment interventions, evidence to support problem solving's mechanism of action is sparse.<h4>Objective</h4>To understand the mechanism of an efficacious depression prevention intervention, problem-solving education (PSE).<h4>Design, setting, and participants</h4>A multivariate path analysis was embedded within a randomized efficacy trial (February 15, 2011, to May 9, 2016). Participants were mothers with depressed mood, anhedonia, or depression history (but not in current major depressive episode) at 1 of 6 Head Start agencies. Participants were followed up for 12 months with serial assessments of potential intervention mediators and depressive symptoms.<h4>Interventions</h4>Problem-solving education (n = 111) and usual Head Start services (n = 119).<h4>Main outcomes and measures</h4>Primary outcomes were depressive symptom elevations, which were measured bimonthly. Eight plausible intervention mediators were assessed: problem-solving ability; mastery; self-esteem; perceived stress; behavioral activation; and avoidant, problem-focused, and social coping.<h4>Results</h4>Among 230 participants, 152 (66.1%) were Hispanic; mean (SD) age was 31.4 (7.3) years. Based on associations with either PSE participation or depressive symptom outcomes, problem-solving ability, perceived stress, behavioral activation, and problem-focused coping were included in a parsimonious, multivariate path model. In this model, only perceived stress was associated with both PSE participation and depressive symptoms. Participants in the PSE group had adjusted standardized perceived stress change scores that were 11% lower than controls (95% CI, -0.19 to -0.03), and improvement in perceived stress generated an adjusted rate ratio (aRR) of 0.42 (95% CI, 0.33-0.53) for depressive symptom elevations. Participants in the intervention group also had standardized behavioral activation change scores 15% greater than controls (95% CI, 0.01-0.30) and problem-focused coping change scores 17% greater than controls (95% CI, 0.03-0.31); however, changes in these constructs were not associated with a differential rate of depressive symptom elevations. The direct effect of PSE on depressive symptom elevations (aRR, 0.72; 95% CI, 0.52-0.97) was greater than the mediated effect explained by improvement in perceived stress (aRR, 0.91; 95% CI, 0.85-0.98).<h4>Conclusions and relevance</h4>Problem-solving education is efficacious in preventing depressive symptoms and appears to work by decreasing perceived stress; however, the mechanism for much of PSE's impact on depression remains unexplained. These results can be used to simplify the intervention model in preparation for effectiveness testing.<h4>Trial registration</h4>ClinicalTrials.gov Identifier: NCT01298804.
Project description:<h4>Introduction</h4>An integrated collaborative care intervention was successful for treating comorbid obesity and depression. The effect of the integrated intervention on secondary outcomes of quality of life and psychosocial functioning were examined, as well as whether improvements in these secondary outcomes were correlated with improvements in the primary outcomes of weight and depressive symptoms.<h4>Study design</h4>This RCT compared an integrated collaborative care intervention for obesity and depression to usual care. Data were analyzed in 2018.<h4>Setting/participants</h4>Adult primary care patients (n=409) with a BMI ≥30 (≥27 if Asian) and 9-Item Patient Health Questionnaire score ≥10 were recruited from September 30, 2014 to January 12, 2017 from primary care clinics in Northern California.<h4>Intervention</h4>The 12-month intervention integrated a behavioral weight loss program and problem-solving therapy with as-needed antidepressant medications for depression.<h4>Main outcome measures</h4>A priori secondary outcomes included health-related quality of life (Short Form-8 Health Survey), obesity-specific quality of life (Obesity-Related Problems Scale), sleep disturbance and sleep-related impairment (Patient-Reported Outcomes Measurement Information System), and functional disability (Sheehan Disability Scale) at baseline and 6 and 12 months.<h4>Results</h4>Participants randomized to the intervention experienced significantly greater improvements in obesity-specific problems, mental health-related quality of life, sleep disturbance, sleep-related impairment, and functional disability at 6 months but not 12 months. Improvements in obesity-related problems (β=0.01, 95% CI=0.01, 0.02) and sleep disturbance (β= -0.02, 95% CI= -0.04, 0) were associated with lower BMI. Improvements in the physical (β= -0.01, 95% CI= -0.01, 0) and mental health components (β= -0.02, 95% CI= -0.03, -0.02) of the Short Form-8 Health Survey as well as sleep disturbance (β=0.01, 95% CI=0.01, 0.02) and sleep-related impairment (β=0.01, 95% CI=0, 0.01) were associated with fewer depressive symptoms.<h4>Conclusions</h4>An integrated collaborative care intervention for obesity and depression that was shown previously to improve weight and depressive symptoms may also confer benefits for quality of life and psychosocial functioning over 6 months.<h4>Trial registration</h4>This study is registered at clinicaltrials.gov NCT02246413.
Project description:<h4>Importance</h4>Preventing depression in older adults living in low- and middle-income countries is important because of the scarcity of treatment resources and the risk of disability, suicide, and dementia.<h4>Objective</h4>To assess whether an intervention for depression prevention provided by lay counselors is effective in older adults from low- and middle-income countries.<h4>Design, setting, and participants</h4>This parallel-group randomized clinical trial with masked outcome assessment was performed in 181 older adults (≥60 years) with subsyndromal depressive symptoms at rural and urban primary care clinics in Goa, India. The first participant entered the trial on March 31, 2015, and the last exited on June 2, 2017. Data analysis used the intention-to-treat approach.<h4>Interventions</h4>Lay counselors provided problem-solving therapy, brief behavioral treatment for insomnia, education in self-care of common medical disorders such as diabetes, and assistance in accessing medical and social programs.<h4>Main outcomes and measures</h4>The main outcome was incidence of major depressive episodes. The study also assessed symptom change during 12 months (12-item General Health Questionnaire [GHQ-12]; score range of 0 to 12, with higher scores indicating greater symptoms of depression and anxiety), functional status (World Health Organization Disability Assessment Schedule 2.0; score range of 12 to 60, with higher scores indicating greater disability), cognition (Hindi Mini-Mental State Examination; score range of 0 to 30, with higher scores indicating better cognitive functioning), blood pressure, and body mass index to provide further clinical context.<h4>Results</h4>The study enrolled 181 participants (mean [SD] age, 69.6 [7.2] years; 114 [63.0%] female): 91 to the intervention arm (depression in later life [DIL] intervention) and 90 to care as usual (CAU). Incident episodes of major depression were lower in the DIL intervention than in the CAU group (4.40% vs 14.44%; log-rank P = .04; number needed to treat, 9.95; 95% CI, 5.12-182.43). The 12-month Kaplan-Meier estimates of percentage of depression-free participants were 95.1% (95% CI, 90.5%-99.9%) in the DIL group vs 87.4% (95% CI, 80.4%-95.1%) in the CAU group. The incidence of depressive symptoms (GHQ-12) was also less (12-month mean difference, -1.18; 95% CI, -2.03 to -0.31; group × time interaction P < .001). There were no changes in measures of disability or cognition. The DIL intervention was associated with a significantly greater lowering of systolic blood pressure (12-month mean difference, -6.98; 95% CI, -11.96 to -2.01; group × time interaction P < .001) and change in body mass index (12-month mean difference, 0.23; 95% CI, -0.97 to 1.43; P = .04).<h4>Conclusions and relevance</h4>The DIL intervention is effective for preventing episodes of major depression in older persons with subsyndromal symptoms. If replicated, the DIL intervention may be effective in older adults living in low- and middle-income countries.<h4>Trial registration</h4>ClinicalTrials.gov Identifier: NCT02145429.
Project description:To test the hypothesis that Problem Solving Therapy (PST) is more effective than Supportive Therapy (ST) in reducing suicidal ideation in older adults with major depression and executive dysfunction. We further explored whether patient characteristics, such as age, sex, and additional cognitive impairment load (e.g., memory impairments) were related to changes in suicidal ideation over time.Secondary data analysis using data from a randomized clinical trial allocating participants to PST or ST at 1:1 ratio. Raters were blind to patients' assignments.University medical centers.221 people aged 65 years old and older with major depression determined by Structured Clinical Interview for DSM-III-R diagnosis and executive dysfunction as defined by a score of 33 or less on the Initiation-Perseveration Score of the Mattis Dementia Rating Scale or a Stroop Interference Task score of 25 or less.12 weekly sessions of PST or ST.The suicide item of the Hamilton Depression Rating Scale.Of the 221 participants, 61% reported suicidal ideation (SI). The ST group had a lower rate of improvement in SI after 12 weeks (44.6%) than did the PST group (60.4%, Fisher's exact test p = 0.031). Logistic regression showed significantly greater reductions in SI in elders who received PST at both 12 weeks (OR: .50, Z = -2.16, p = 0.031) and 36 weeks (OR: 0.5, Z = -1.96, p = 0.05) after treatment.PST is a promising intervention for older adults who are at risk for suicide. ClinicalTrials.gov Identifier: NCT00052091.
Project description:<h4>Purpose</h4>To compare the efficacy of problem-solving therapy (PST) with supportive therapy (ST) to improve targeted vision function (TVF) in age-related macular degeneration (AMD).<h4>Design</h4>Single-masked, attention-controlled, randomized clinical trial with outcome assessments at 3 months (main trial endpoint) and 6 months (maintenance effects).<h4>Participants</h4>Patients with AMD (n = 241) attending retina practices.<h4>Interventions</h4>Whereas PST uses a structured problem-solving approach to reduce vision-related task difficulty, ST is a standardized attention-control treatment.<h4>Main outcome measures</h4>We assessed TVF, the 25-item National Eye Institute Vision Function Questionnaire plus Supplement (NEI VFQ), the Activities Inventory (AI), and vision-related quality of life (QoL).<h4>Results</h4>There were no between-group differences in TVF scores at 3 (P = 0.47) or 6 (P = 0.62) months. For PST subjects, mean ± standard deviation TVF scores improved from 2.71±0.52 at baseline to 2.18±0.88 at 3 months (P = 0.001) and were 2.18±0.95 at 6 months (change from 3 to 6 months, P = 0.74). For ST subjects, TVF scores improved from 2.73±0.52 at baseline to 2.14±0.96 at 3 months (P = 0.001) and were 2.15±0.96 at 6 months (change from 3 to 6 months, P = 0.85). Similar proportions of PST and ST subjects had less difficulty performing a TVF goal at 3 months (77.4% vs 78.6%, respectively; P = 0.83) and 6 months (76.2% vs 79.1%, respectively; P = 0.61). There were no changes in the NEI VFQ or AI. Vision-related QoL improved for PST relative to ST subjects at 3 months (F(4, 192) = 2.46; P = 0.05) and at 6 months (F(4, 178) = 2.55; P = 0.05). The PST subjects also developed more adaptive coping strategies than ST subjects.<h4>Conclusions</h4>We found that PST was not superior to ST at improving vision function in patients with AMD, but that PST improved their vision-related QoL. Despite the benefits of anti-vascular endothelial growth factor treatments, AMD remains associated with disability, depression, and diminished QoL. This clinical reality necessitates new rehabilitative interventions to improve the vision function and QoL of older persons with AMD.<h4>Financial disclosure(s)</h4>The authors have no proprietary or commercial interest in any of the materials discussed in this article.
Project description:To test the following hypotheses: (1) Clinical case management integrated with problem-solving therapy (CM-PST) is more effective than clinical case management alone (CM) in improving functional outcomes in disabled, impoverished patients and (2) improvement in depression, self-efficacy, and problem-solving skills mediates improvement of disability.Using a randomized controlled trial with a parallel design, 271 individuals were screened and 171 were randomized to 12 weekly sessions of either CM or CM-PST at 1:1 ratio. Raters were blind to patients' assignments. Participants were at least age 60 years with major depression, had at least one disability, were eligible for home-based meals services, and had income no more than 30% of their counties' median. The WHO Disability Assessment Scale was used.Both interventions resulted in improved functioning by 12 weeks (t = 4.28, df = 554, p = 0.001), which was maintained until 24 weeks. Contrary to hypothesis, CM was noninferior to CM-PST (one-sided p = 0.0003, t = -3.5, df = 558). Change in disability was not affected by baseline depression severity, cognitive function, or number of unmet social service needs. Improvements in self efficacy (t = -2.45, df = 672, p = 0.021), problem-solving skill (t = -2.44, df = 546, p = 0.015), and depression symptoms (t = 2.25, df = 672, p = .025) by week 9 predicted improvement in function across groups by week 12.CM is noninferior to CM-PST for late-life depression in low-income populations. The effect of these interventions occur early, with benefits in functional status maintained as long as 24 weeks after treatment initiation (clinicaltrials.gov; NCT00540865).