TY - JOUR
T1 - Site-Randomized Controlled Trial of a Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression Among Youth Living With HIV in the United States
AU - IMPAACT 2002 team
AU - Brown, Larry K.
AU - Chernoff, Miriam
AU - Kennard, Betsy D.
AU - Emslie, Graham J.
AU - Lypen, Kathryn
AU - Buisson, Sarah
AU - Weinberg, Adriana
AU - Whiteley, Laura B.
AU - Traite, Shirley
AU - Krotje, Chelsea
AU - Harriff, Lauren
AU - Townley, Ellen
AU - Bunch, Amber
AU - Purswani, Murli
AU - Shaw, Ray
AU - Spector, Stephen A.
AU - Agwu, Allison
AU - Shapiro, David E.
N1 - Funding Information:
The authors thank the patients, the investigators, and the staff at the study sites for their contributions to the study. The authors also thank Hiroaki Itoh for providing medical writing assistance and Dr Shama Buch of Cactus Communications for providing medical writing and editorial assistance (both funded by Taisho Pharmaceuticals Co. Ltd.). The authors have retained full control of the manuscript content.
Funding Information:
M. Haneda has received consulting fees, lecture fees, payment for manuscript writing, research support, or grants from Sanofi, Tanabe Mitsubishi, Takeda, Eli Lilly, Boehringer Ingelheim, Novo Nordisk, Novartis, MSD, Kyowa Hakko Kirin, Daiichi Sankyo, Astellas, Kowa, Asahi Kasei Pharma, Ajinomoto Pharma, Otsuka, Ono, Kaken, Kissei, Glaxo SmithKline, Sanwa Kagaku Kenkyusho, Shionogi, Johnson & Johnson, Sumitomo Dainippon, Chugai, Teijin Pharma, Terumo, Torii, Bayer Yakuhin, Pfizer, Bristol-Myers Squibb, Mochida, Roche Diagnostics, AstraZeneca, Taisho Toyama, and Taisho. Y. Seino has received consulting fees, lecture fees, advisor fees, moderator fees, payment for manuscript writing, or research support from Sanofi, Novo Nordisk, Eli Lilly, Glaxo SmithKline, Astellas, Takeda, Boehringer Ingelheim, Johnson & Johnson, Becton Dickinson, AstraZeneca, MSD, Ono, Kyowa Hakko Kirin, Kao, Daiichi Sankyo, Tanabe Mitsubishi, Sumitomo Dainippon, Novartis, Bristol-Myers Squibb, Kissei, Terumo, Kowa, Taisho Toyama, and Taisho. N. Inagaki has received advisory board consulting fees, lecture fees, moderator fees, grants, or research support from Takeda, Glaxo SmithKline, Tanabe Mitsubishi, MSD, Sanofi, Novartis, Sumitomo Dainippon, Kyowa Hakko Kirin, Eli Lily, Shiratori, Roche Diagnostics, Japan Diabetes Foundation, JT, Boehringer Ingelheim, Astellas, Daiichi Sankyo, Ono, AstraZeneca, Kowa, Taisho Toyama, and Taisho. K. Kaku has received advisory board consulting fees, consulting fees, lecture fees, research support, or grants from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Sumitomo Dainippon, Kowa, MSD, Novartis, Novo Nordisk, Takeda, Sanofi, Sanwa Kagaku Kenkyusho, Tanabe Mitsubishi, Taisho Toyama, and Taisho. T. Sasaki has received research fund, consulting fees, or lecture fees from Canon Inc., Sanofi, Kowa, Tanabe Mitsubishi, Novo Nordisk, MSD, LIGHT Study Group (LIGHT Study; UMIN ID 000015112), Taisho Toyama, and Taisho. A. Fukatsu has received consulting fees or lecture fees from Taisho Toyama and Taisho. H. Kakiuchi, Y. Sato, S. Sakai, and Y. Samukawa are employees of Taisho. The authors have indicated that they have no other conflicts of interest regarding the content of this article.
Publisher Copyright:
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2021/12/15
Y1 - 2021/12/15
N2 - BACKGROUND: Depression is frequent among youth living with HIV (YLWH). Studies suggest that manualized treatment guided by symptom measurement is more efficacious than usual care. SETTING: This study evaluated manualized, measurement-guided depression treatment among YLWH, aged 12-24 years at 13 US sites of the International Maternal Pediatric Adolescent AIDS Clinical Trials Network. METHODS: Using restricted randomization, sites were assigned to either a 24-week, combination cognitive behavioral therapy and medication management algorithm (COMB-R) tailored for YLWH or to enhanced standard of care, which provided standard psychotherapy and medication management. Eligibility included diagnosis of nonpsychotic depression and current depressive symptoms. Arm comparisons used t tests on site-level means. RESULTS: Thirteen sites enrolled 156 YLWH, with a median of 13 participants per site (range 2-16). At baseline, there were no significant differences between arms on demographic factors, severity of depression, or HIV status. The average site-level participant characteristics were as follows: mean age of 21 years, 45% male, 61% Black, and 53% acquired HIV through perinatal transmission. At week 24, youth at COMB-R sites, compared with enhanced standard of care sites, reported significantly fewer depressive symptoms on the Quick Inventory for Depression Symptomatology Self-Report (QIDS-SR score 6.7 vs. 10.6, P = 0.01) and a greater proportion in remission (QIDS-SR score ≤ 5; 47.9% vs. 17.0%, P = 0.01). The site mean HIV viral load and CD4 T-cell level were not significantly different between arms at week 24. CONCLUSIONS: A manualized, measurement-guided psychotherapy and medication management algorithm tailored for YLWH significantly reduced depressive symptoms compared with standard care at HIV clinics.
AB - BACKGROUND: Depression is frequent among youth living with HIV (YLWH). Studies suggest that manualized treatment guided by symptom measurement is more efficacious than usual care. SETTING: This study evaluated manualized, measurement-guided depression treatment among YLWH, aged 12-24 years at 13 US sites of the International Maternal Pediatric Adolescent AIDS Clinical Trials Network. METHODS: Using restricted randomization, sites were assigned to either a 24-week, combination cognitive behavioral therapy and medication management algorithm (COMB-R) tailored for YLWH or to enhanced standard of care, which provided standard psychotherapy and medication management. Eligibility included diagnosis of nonpsychotic depression and current depressive symptoms. Arm comparisons used t tests on site-level means. RESULTS: Thirteen sites enrolled 156 YLWH, with a median of 13 participants per site (range 2-16). At baseline, there were no significant differences between arms on demographic factors, severity of depression, or HIV status. The average site-level participant characteristics were as follows: mean age of 21 years, 45% male, 61% Black, and 53% acquired HIV through perinatal transmission. At week 24, youth at COMB-R sites, compared with enhanced standard of care sites, reported significantly fewer depressive symptoms on the Quick Inventory for Depression Symptomatology Self-Report (QIDS-SR score 6.7 vs. 10.6, P = 0.01) and a greater proportion in remission (QIDS-SR score ≤ 5; 47.9% vs. 17.0%, P = 0.01). The site mean HIV viral load and CD4 T-cell level were not significantly different between arms at week 24. CONCLUSIONS: A manualized, measurement-guided psychotherapy and medication management algorithm tailored for YLWH significantly reduced depressive symptoms compared with standard care at HIV clinics.
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U2 - 10.1097/QAI.0000000000002790
DO - 10.1097/QAI.0000000000002790
M3 - Article
C2 - 34483297
AN - SCOPUS:85123879032
VL - 88
SP - 497
EP - 505
JO - Journal of Acquired Immune Deficiency Syndromes
JF - Journal of Acquired Immune Deficiency Syndromes
SN - 1525-4135
IS - 5
ER -