Sleep to Reduce Incident Depression Effectively (STRIDE): Study Protocol for a Randomized Controlled Trial Comparing Stepped-care Cognitive-behavioral Therapy for Insomnia Versus Sleep Education Control to Prevent Major Depression

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2022 Dec 2

PMID 36457045

Authors

Christopher L Drake

David A Kalmbach

Philip Cheng

Brian K Ahmedani

Edward L Peterson

Christine L M Joseph

Thomas Roth

Kelley M Kidwell

Chaewon Sagong

Affiliations

Soon will be listed here.

Abstract

Background: Prevention of major depressive disorder (MDD) is a public health priority. Strategies targeting individuals at elevated risk for MDD may guide effective preventive care. Insomnia is a reliable precursor to depression, preceding half of all incident and relapse cases. Thus, insomnia may serve as a useful entry point for preventing MDD. Cognitive-behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment for insomnia, but widespread implementation is limited by a shortage of trained specialists. Innovative stepped-care approaches rooted in primary care can increase access to CBT-I and reduce rates of MDD.

Methods/design: We propose a large-scale stepped-care clinical trial in the primary care setting that utilizes a sequential, multiple assignment, randomized trial (SMART) design to determine the effectiveness of dCBT-I alone and in combination with clinician-led CBT-I for insomnia and the prevention of MDD incidence and relapse. Specifically, our care model uses digital CBT-I (dCBT-I) as a first-line intervention to increase care access and reduce the need for specialist resources. Our proposal also adds clinician-led CBT-I for patients who do not remit with first-line intervention and need a more personalized approach from specialty care. We will evaluate negative repetitive thinking as a potential treatment mechanism by which dCBT-I and CBT-I benefit insomnia and depression outcomes.

Discussion: This project will test a highly scalable model of sleep care in a large primary care system to determine the potential for wide dissemination and implementation to address the high volume of population need for safe and effective insomnia treatment and associated prevention of depression.

Trial Registration: ClinicalTrials.gov NCT03322774. Registered on October 26, 2017.

Citing Articles

The Impact of Sleep Disorders on Cardiovascular Health: Mechanisms and Interventions.

Sarode R, Nikam P Cureus. 2024; 15(11):e49703.

PMID: 38161933 PMC: 10757461. DOI: 10.7759/cureus.49703.

Disseminating sleep education to graduate psychology programs online: a knowledge translation study to improve the management of insomnia.

Meaklim H, Meltzer L, Rehm I, Junge M, Monfries M, Kennedy G Sleep. 2023; 46(10).

PMID: 37327117 PMC: 10566250. DOI: 10.1093/sleep/zsad169.

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