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

Abstract

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.

Figure 1.

CONSORT Diagram for IMPAACT 2002

Figure 2.

Site Mean QIDS-SR by Treatment and Week. Summary statistics are based on observations representing the mean of the individual QIDS-SR scores for each site. Shaded boxes represent COMB-R sites. Unshaded boxes represent ESC sites. Box plots represent medians (bar), 25^th percentile (lower limit of box) and 75^th percentile (upper limit of box). The mean of the site means are shown by a small square. Whiskers are drawn to the maximum (minimum) observation below (above) the upper (lower) fence, which is 1.5*Interquartile range (IQR) above (below) the 75^th (25^th) percentiles. A horizontal line drawn at the value of 5 represents QIDS-SR remission, which is a score of 5 or less.

Figure 3.

Site Percent with QIDS-SR Response by Treatment and Week. Summary statistics are based on observations representing the percent of individuals at each site with a QIDS-SR response, which is a decrease of over 50% from study entry to week 24. Shaded boxes represent COMB-R sites. Unshaded boxes represent ESC sites. Box plots represent medians (bar), 25^th percentile (lower limit of box) and 75^th percentile (upper limit of box). The mean of the site percentages are shown by a small square. Whiskers are drawn to the maximum (minimum) observation below (above) the upper (lower) fence, which is 1.5*Interquartile range (IQR) above (below) the 75^th (25^th) percentiles.