A Novel Approach for Developing and Interpreting Treatment Moderator Profiles in Randomized Clinical Trials

IMPORTANCE Identifying treatment moderators may help mental health practitioners arrive at more precise treatment selection for individual patients and can focus clinical research on subpopulations that differ in treatment response. OBJECTIVE To demonstrate a novel exploratory approach to moderation analysis in randomized clinical trials. DESIGN, SETTING, AND PARTICIPANTS A total of 291 adults from a randomized clinical trial that compared an empirically supported psychotherapy with selective serotonin reuptake inhibitor (SSRI) pharmacotherapy as treatments for depression. MAIN OUTCOMES AND MEASURES We selected 8 relatively independent individual moderators out of 32 possible variables. A combined moderator, M*, was developed as a weighted combination of the 8 selected individual moderators. M* was then used to identify individuals for whom psychotherapy may be preferred to SSRI pharmacotherapy or vice versa. RESULTS Among individual moderators, psychomotor activation had the largest moderator effect size (0.12; 95% CI,