Comparative Effectiveness of Psychotherapy vs Antidepressants for Depression in Heart Failure: A Randomized Clinical Trial.

Importance: Heart failure (HF) affects more than 6 million adults in the US and more than 64 million adults worldwide, with 50% prevalence of depression. Patients and clinicians lack information on which interventions are more effective for depression in HF. Objective: To compare the effectiveness of behavioral activation psychotherapy (BA) vs antidepressant medication management (MEDS) on patient-centered outcomes inpatients with HF and depression. Design, Setting, and Participants: This pragmatic randomized comparative effectiveness trial was conducted from 2018 to 2022, including 1-year follow-up, at a not-for-profit academic health system serving more than 2 million people from diverse demographic, socioeconomic, cultural, and geographic backgrounds. Participant included inpatients and outpatients diagnosed with HF and depression, and data were analyzed as intention-to-treat. Data were analyzed from 2022 to 2023. Interventions: BA is an evidence-based manualized treatment for depression, promoting engagement in personalized pleasurable activities selected by patients. MEDS involves the use of an evidence-based collaborative care model with care managers providing coordination with patients, psychiatrists, and primary care physicians to only administer medications. Main Outcomes and Measures: The primary outcome was depressive symptom severity at 6 months, measured using the Patient Health Questionnaire 9-Item (PHQ-9). Secondary outcomes included physical and mental health-related quality of life (HRQOL), measured using the Short-Form 12-Item version 2 (SF-12); heart failure-specific HRQOL, measured using the Kansas City Cardiomyopathy Questionnaire; caregiver burden, measured with the Caregiver Burden Questionnaire for Heart Failure; emergency department visits; readmissions; days hospitalized; and mortality at 3, 6, and 12 months. Results: A total of 416 patients (mean [SD] age, 60.71 [15.61] years; 243 [58.41%] male) were enrolled, with 208 patients randomized to BA and 208 patients randomized to MEDS. At baseline, mean (SD) PHQ-9 scores were 14.54 (3.45) in the BA group and 14.31 (3.60) in the MEDS group; both BA and MEDS recipients experienced nearly 50% reduction in depressive symptoms at 3, 6, and 12 months (eg, mean [SD] score at 12 months: BA, 7.62 (5.73); P < .001; MEDS, 7.98 (6.06); P < .001; between-group P = .55). There was no statistically significant difference between BA and MEDS in the primary outcome of PHQ-9 at 6 months (mean [SD] score, 7.53 [5.74] vs 8.09 [6.06]; P = .88). BA recipients, compared with MEDS recipients, experienced small improvement in physical HRQOL at 6 months (mean [SD] SF-12 physical score: 38.82 [11.09] vs 37.12 [10.99]; P = .04), had fewer ED visits (3 months: 38% [95% CI, 14%-55%] reduction; P = .005; 6 months: 30% [95% CI, 14%-40%] reduction; P = .008; 12 months: 27% [95% CI, 15%-38%] reduction; P = .001), and spent fewer days hospitalized (3 months: 17% [95% CI, 8%-25%] reduction; P = .002; 6 months: 19% [95% CI, 13%-25%] reduction; P = .005; 12 months: 36% [95% CI, 32%-40%] reduction; P = .001). Conclusions and Relevance: In this comparative effectiveness trial of BA and MEDS in patients with HF experiencing depression, both treatments significantly reduced depressive symptoms by nearly 50% with no statistically significant differences between treatments. BA recipients experienced better physical HRQOL, fewer ED visits, and fewer days hospitalized. The study findings suggested that patients with HF could be given the choice between BA or MEDS to ameliorate depression. Trial Registration: ClinicalTrials.gov Identifier: NCT03688100.

Pilot randomized controlled trial of a hospital-based substance use treatment and recovery team (START) to improve initiation of medication for alcohol or opioid use disorder and linkage to follow-up care.

OBJECTIVES: We conducted a pilot randomized controlled trial (RCT) to explore whether a hospital inpatient addiction consult team (Substance Use Treatment and Recovery Team [START]) based on collaborative care was feasible, acceptable to patients, and whether it could improve uptake of medication in the hospital and linkage to care after discharge, as well as reduce substance use and hospital readmission. The START consisted of an addiction medicine specialist and care manager who implemented a motivational and discharge planning intervention. METHODS: We randomized inpatients age ≥ 18 with a probable alcohol or opioid use disorder to receive START or usual care. We assessed feasibility and acceptability of START and the RCT, and we conducted an intent-to-treat analysis on data from the electronic medical record and patient interviews at baseline and 1-month postdischarge. The study compared RCT outcomes (medication for alcohol or opioid use disorder, linkage to follow-up care after discharge, substance use, hospital readmission) between arms by fitting logistic and linear regression models. FINDINGS: Of 38 START patients, 97 % met with the addiction medicine specialist and care manager; 89 % received ≥8 of 10 intervention components. All patients receiving START found it to be somewhat or very acceptable. START patients had higher odds of initiating medication during the inpatient stay (OR 6.26, 95 % CI = 2.38-16.48, p < .001) and being linked to follow-up care (OR 5.76, 95 % CI = 1.86-17.86, p < .01) compared to usual care patients (N = 50). The study found no significant differences between groups in drinking or opioid use; patients in both groups reported using fewer substances at the 1-month follow-up. CONCLUSIONS: Pilot data suggest START and RCT implementation are feasible and acceptable and that START may facilitate medication initiation and linkage to follow-up for inpatients with an alcohol or opioid use disorder. A larger trial should assess effectiveness, covariates, and moderators of intervention effects.