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

Stopped early · Not applicable

Conditions studied: Sleep Initiation and Maintenance Disorders, Suicidal Ideation

In brief

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.

Key facts

Study ID

NCT04986007

Run by

MICHAEL A GRANDNER

People needed

23

Starts

2021-09-01

Expected to finish

2025-07-22

Last updated by the study team

2025-08-06

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals 55 and older
• English speaking
• Male or female
• Current insomnia (Insomnia Severity Index score ≥ 8 during the baseline period).
• Recent suicidal ideation (endorsement of Items 1 or 2 of the Columbia Suicide Severity Rating Scale - Suicidal Ideation subscale within the past month).
• All participants must consent to a release of information between the research team and their treatment provider (either their prescribing psychiatrist, their masters-level non-trainee therapist, or their doctoral-level psychologist).

You may not qualify if…

• Diagnosis of bipolar disorder, any psychotic disorder, or other serious mental illness deemed a contraindication for dCBT-I.
• If a subject is taking psychotropic medication(s) (e.g., antidepressants, hypnotics), they should not have changed the dose within the past 6 weeks and should agree to not change the dose during the trial.
• If a subject is not taking psychotropic medication(s), they should be medication free for at least 6 weeks and should agree to not start a new medication for the duration of the trial.
• Suspicion or evidence of untreated sleep apnea, restless legs syndrome, or other untreated sleep disorder requiring treatment by a physician.
• Uncontrolled or unstable chronic medical conditions
• Life expectancy of less than 1 year as determined by record review and intake interview.
• Cognitive impairment sufficient to impair delivery or retention of dCBT-I as indicated by the Short Blessed Test.
• Are currently or are planning to work evening/overnight shifts.
• Lack of access to internet or technology necessary to engage in digital therapy.
• Participants who have been hospitalized for a suicide attempt or severe suicidal ideation, or who endorse any intent to commit suicide in the last 3 months must receive assent/approval from their treatment provider to participate, in addition to providing a release of information for the research team to communicate with the treatment team.

Where it is running

• Banner Whole Health Clinic — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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