TY - JOUR
T1 - Comparative efficacy of therapies for treatment of depression for patients undergoing maintenance hemodialysis
AU - Mehrotra, Rajnish
AU - Cukor, Daniel
AU - Unruh, Mark
AU - Rue, Tessa
AU - Heagerty, Patrick
AU - Cohen, Scott D.
AU - Dember, Laura M.
AU - Diaz-Linhart, Yaminette
AU - Dubovsky, Amelia
AU - Greene, Tom
AU - Grote, Nancy
AU - Kutner, Nancy
AU - Trivedi, Madhukar H.
AU - Quinn, Davin K.
AU - Halen, Nishaver
AU - Weisbord, Steven D.
AU - Young, Bessie A.
AU - Kimmel, Paul L.
AU - Hedayati, S. Susan
N1 - Funding Information:
Financial Support: This trial was funded by contract CER-1310-07253 from the Patient-Centered Outcomes Research Institute. Additional support was provided by Dialysis Clinic Inc. (Nashville, Tennessee); the Kidney Research Institute at the University of Washington, Seattle; and grant R01DK085512 from the National Institute of Diabetes and Digestive and Kidney Diseases (to Dr. Hedayati). Dr. Young is supported in part by funding from the Veterans Affairs Puget Sound Healthcare System.
Funding Information:
Disclosures: Ms. Diaz-Linhart reports personal fees from the University of Washington during the conduct of the study. Dr. Greene reports grants from the National Institutes of Health during the conduct of the study and personal fees from Jans-sen Pharmaceuticals, Durect Corporation, and Pfizer and grants from AstraZeneca outside the submitted work. Dr. Trivedi reports personal fees from AcademyHealth, Acadia Pharmaceuticals, Alkermes, Akili Interactive, Allergan, Ax-some Therapeutics, Boehringer Ingelheim, Healthcare Global Village, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Lun-dbeck Research USA, Medscape, Navitor, Otsuka America Pharmaceutical, Oxford Pharmagenesis, and Sage Therapeutics, and grants from the National Institute of Mental Health, National Institute on Drug Abuse, Cancer Prevention Research Institute of Texas, and Janssen Pharmaceuticals, outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www .acponline.org/authors/icmje/ConflictOfInterestForms.do?ms Num=M18-2229.
PY - 2019
Y1 - 2019
N2 - Background: Although depression is common among patients receiving maintenance hemodialysis, data on their acceptance of treatment and on the comparative efficacy of various therapies are limited. Objective: To determine the effect of an engagement interview on treatment acceptance (phase 1) and to compare the efficacy of cognitive behavioral therapy (CBT) versus sertraline (phase 2) for treating depression in patients receiving hemodialysis. Design: Multicenter, parallel-group, open-label, randomized controlled trial. (ClinicalTrials.gov: NCT02358343) Setting: 41 dialysis facilities in 3 U.S. metropolitan areas. Participants: Patients who had been receiving hemodialysis for at least 3 months and had a Beck Depression Inventory-II score of 15 or greater; 184 patients participated in phase 1, and 120 subsequently participated in phase 2. Intervention: Engagement interview versus control visit (phase 1) and 12 weeks of CBT delivered in the dialysis facility versus sertraline treatment (phase 2). Measurements: The primary outcome for phase 1 was the proportion of participants who started depression treatment within 28 days. For phase 2, the primary outcome was depressive symptoms measured by the Quick Inventory of Depressive Symptoms Clinician-Rated (QIDS-C) at 12 weeks. Results: The proportion of participants who initiated treatment after the engagement or control visit did not differ (66% vs. 64%, respectively; P = 0.77; estimated risk difference, 2.1 [95% CI, _12.1 to 16.4]). Compared with CBT, sertraline treatment resulted in lower QIDS-C depression scores at 12 weeks (effect estimate, _1.84 [CI, _3.54 to _0.13]; P = 0.035). Adverse events were more frequent in the sertraline than the CBT group. Limitation: No randomized comparison was made with no treatment, and persistence of treatment effect was not assessed. Conclusion: An engagement interview with patients receiving maintenance hemodialysis had no effect on their acceptance of treatment for depression. After 12 weeks of treatment, depression scores were modestly better with sertraline treatment than with CBT. Primary Funding Source: Patient-Centered Outcomes Research Institute, Dialysis Clinic, Kidney Research Institute, and National Institute of Diabetes and Digestive and Kidney Diseases.
AB - Background: Although depression is common among patients receiving maintenance hemodialysis, data on their acceptance of treatment and on the comparative efficacy of various therapies are limited. Objective: To determine the effect of an engagement interview on treatment acceptance (phase 1) and to compare the efficacy of cognitive behavioral therapy (CBT) versus sertraline (phase 2) for treating depression in patients receiving hemodialysis. Design: Multicenter, parallel-group, open-label, randomized controlled trial. (ClinicalTrials.gov: NCT02358343) Setting: 41 dialysis facilities in 3 U.S. metropolitan areas. Participants: Patients who had been receiving hemodialysis for at least 3 months and had a Beck Depression Inventory-II score of 15 or greater; 184 patients participated in phase 1, and 120 subsequently participated in phase 2. Intervention: Engagement interview versus control visit (phase 1) and 12 weeks of CBT delivered in the dialysis facility versus sertraline treatment (phase 2). Measurements: The primary outcome for phase 1 was the proportion of participants who started depression treatment within 28 days. For phase 2, the primary outcome was depressive symptoms measured by the Quick Inventory of Depressive Symptoms Clinician-Rated (QIDS-C) at 12 weeks. Results: The proportion of participants who initiated treatment after the engagement or control visit did not differ (66% vs. 64%, respectively; P = 0.77; estimated risk difference, 2.1 [95% CI, _12.1 to 16.4]). Compared with CBT, sertraline treatment resulted in lower QIDS-C depression scores at 12 weeks (effect estimate, _1.84 [CI, _3.54 to _0.13]; P = 0.035). Adverse events were more frequent in the sertraline than the CBT group. Limitation: No randomized comparison was made with no treatment, and persistence of treatment effect was not assessed. Conclusion: An engagement interview with patients receiving maintenance hemodialysis had no effect on their acceptance of treatment for depression. After 12 weeks of treatment, depression scores were modestly better with sertraline treatment than with CBT. Primary Funding Source: Patient-Centered Outcomes Research Institute, Dialysis Clinic, Kidney Research Institute, and National Institute of Diabetes and Digestive and Kidney Diseases.
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M3 - Article
C2 - 22273670
AN - SCOPUS:85063918614
VL - 170
SP - 369
EP - 379
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
SN - 0003-4819
IS - 6
ER -