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Addressing Nocturnal Sleep/Wake Effects on Risk of Suicide in Older Adults

NCT04986007 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-08-06

No results posted yet for this study

Summary

Suicide is a leading cause of death in the US, and insomnia is a risk factor for suicidal thoughts and behaviors. In older adults, suicide is associated with impaired cognitive functioning, and insomnia, which is more prevalent in older adults, is also linked to disrupted cognition. However, there is limited evidence on whether treatment of insomnia can improve suicidal ideation (with or without improving cognition), and no evidence specifically in older adults. Additionally, no studies have investigated digital cognitive behavioral therapy for insomnia (dCBT-I) in this populations. Consequently, this study will help inform future study designs and provide preliminary data on whether dCBT-I is effective for suicidal thinking in older adults.

Conditions

Interventions

BEHAVIORAL

Digital Cognitive Behavioral Therapy for Insomnia

Digital cognitive behavioral therapy for insomnia is an automated, internet-based delivery system for the core components of cognitive behavioral therapy for insomnia (CBT-I). For this trial, dCBT-I will be delivered using Sleep Healthy Using the Internet (SHUTi), which delivers the core content of CBT-I in 6 interactive lessons called Cores: Getting Ready; Sleep Scheduling; Sleep Practices; Thinking Differently; Sleep Hygiene; and Moving On. The primary therapeutic approaches deployed through these cores are stimulus control and sleep restriction. The minimum acceptable dose for this study is completion of 4 out of 6 cores; completion of fewer than 4 cores will be considered a dropout.

Sponsors & Collaborators

Principal Investigators

  • Michael A Grandner, PhD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2025-07-22
Completion
2025-07-22

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04986007 on ClinicalTrials.gov