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A Pragmatic Randomized Controlled Trial of Stepped Care Cognitive-behavioral Therapy for Internalizing Distress in Adults

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Abstract

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.

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Funding

This research was funded by: the Indiana University Center for Rural Engagement, the National Institute of Mental Health grant T32 MH103213-06 which provided support for Peipert, De Jesús-Romero, Buss, and Starvaggi) and grant numbers KL2TR002530 and UL1TR002529 (A. Shekhar, PI) from the National Institutes of Health, National Center for Advancing Translational Sciences, Clinical and Translational Sciences Award which provided support for Prof. Lorenzo-Luaces.

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Conceptualization: LL-L, JH. Data curation: LL-L. Formal Analysis: LL-L. Funding acquisition: LL-L. Investigation: LL-L, JH, RDJ-R, AP, JB, CL, IS. Methodology: LL-L. Project administration: LL-L, JH, CD. Resources: LL-L. Software: LL-L. Supervision: LL-L. Validation: LL-L. Visualization: LL-L. Writing ? original draft: LL-L. Writing review & editing: LL-L, JH, RDJ-R, AP, JB, CL, IS, RF, CD, SA, IR.

Corresponding author

Correspondence to Lorenzo Lorenzo-Luaces.

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Conflicts of Interest

Prof. Lorenzo-Luaces and Robert Fite have received consulting fees from Syra Health, inc. who had no role in the current research. The other authors declare no conflict of interest.

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Informed consent was obtained from all individual participants included in the study.

Research Involving Human Participants and/or Animals

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Indiana University IRB.

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Lorenzo-Luaces, L., Dierckman, C., Lind, C. et al. A Pragmatic Randomized Controlled Trial of Stepped Care Cognitive-behavioral Therapy for Internalizing Distress in Adults. Cogn Ther Res (2024). https://doi.org/10.1007/s10608-024-10489-7

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