A Pragmatic Randomized Controlled Trial of Stepped Care Cognitive-Behavioral Therapy (CBT) for Internalizing Distress and Emotion Regulation in Adults in Indiana

Introduction: Transdiagnostic self-help cognitive behavioral therapy (CBT) approaches may help ease the burden of untreated symptoms of internalizing distress, especially in geographic areas with relatively small numbers of mental health providers. Methods: Over the course of 12 months, we conducted a six-week randomized controlled trial (N = 275) across Indiana, a state with high unmet need for mental health care. All participants were given immediate access to a single-session intervention (SSI) followed by randomization to either guided or unguided CBT-based bibliotherapy. We used mixed models to model change over time in distress, well-being, and emotion regulation as a piecewise function of study week. Results: The sample was in their early 30s (M= 34.10, SD=11.68), mostly female (75.64%, n=208) and, consistent with the demographics of the state, mostly Non-Hispanic White (80.36%, n=221). Less than half of participants accessed the SSI (39.27%, n=108). There was no evidence that completing the SSI was associated with improved outcomes, though it improved study engagement. Participants randomized to the guided (vs. unguided) condition experienced greater overall improvements in internalizing distress (SMD=-0.44, 95% CI: -0.74, -0.13) and cognitive reappraisal (SMD=0.32, 95% CI: 0.06, 0.58). The differences between groups in improvements in well-being (SMD=0.25, 95% CI: -0.13, 0.63) and expressive suppression (SMD=-0.24, 95% CI: -0.55, 0.07) were smaller and not statistically significant. Virtually all participants expressed some interest in more therapy via telehealth (89.74%, n=140). Findings were sensitive to multiple imputation using random forests as well as propensity score matching. Discussion: Self-help approaches are scalable interventions for individuals in under-served states. As in previous work, guided self-help was more effective than unguided self-help. More work should focus on adding additional treatment steps past self-help.