Substantial numbers of depressed adolescents either decline antidepressant medication or quickly discontinue such medications before benefits are expected. Recent controversies regarding the safety of SSRI anti-depressants are likely to increase medication refusal. More than half of depressed adolescents identified in primary care prefer psychosocial treatments, compared to.20% who prefer medication. Among the psychotherapy alternatives to medication, CBT has the strongest research support. We have already developed a collaborative care CBT model that we evaluated in a previous primary care trial. However, this previous trial did not specifically examined its effects in the absence of medication treatment. Therefore, we propose to conduct a two-arm, randomized, efficacy-effectiveness trial in a Health Maintenance Organization (HMO), comparing a treatment as usual (TAD) control condition to TAU plus brief, individual, collaborative care CBT. We will enroll 240 youth ages 12 to 18 who, during this depressive episode, have either declined anti-depressant medication or who received a single dispense of anti-depressant medication but quickly discontinued. All enrolled cases will be reassessed periodically throughout a 24-month follow-up period. The primary clinical outcome is recovery from the index episode of major depression, assessed via LIFE/K-SADS diagnosis. Secondary outcomes include continuous depression symptomatology;depression response;rates of new, recurrent episodes of major depression in the follow-up period;improvements in psychosocial function;clinical improvement;reduction in depressionrelated dysfunction;parent/youth attitudes regarding treatment. We will also examine incremental costeffectiveness of CBT compared to TAU from the HMO, family, and societal perspectives. We will conduct exploratory analyses of mediation and moderation of depression treatment outcomes, and employ data from the TAU control condition to estimate the usual outcomes for depressed youth who refuse/discontinue antidepressant medication. Finally, we will examine how provider, parent and youth barriers, attitudes and beliefs moderate outcomes, as well as possibly change over time as a function of participation in this program. The validation of a primary care model for brief CC-CBT may prove to be a significant benefit to the sizeable numbers of depressed youth identified in primary care, and who elect not to try antidepressant medication or quickly discontinue an initial trial.
|Clarke, Gregory; DeBar, Lynn L; Pearson, John A et al. (2016) Cognitive Behavioral Therapy in Primary Care for Youth Declining Antidepressants: A Randomized Trial. Pediatrics 137:|