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

NCT04986007 | Terminated

• 1 other identifier: ANSWERS-OA
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Sleep Initiation and Maintenance Disorders; Suicidal Ideation

Keywords

Randomized Clinical Trial; digital Cognitive Behavioral Therapy for Insomnia; Older Adults; Suicidal Ideation; Insomnia

Outcome Measures

Primary Outcomes (3)

• Aim 1a: Evaluate whether dCBT-I is a feasible intervention for older adults with insomnia and suicidal ideation.

  Sub-aim 1a: Determine participant engagement with 10 weeks of dCBT-I. Metric: Percent of subjects enrolled who complete the 10 week treatment period

  Up to 24 weeks.

• Aim 1b: Evaluate whether dCBT-I is a feasible intervention for older adults with insomnia and suicidal ideation.

  Sub-aim 1b: Measure participant adherence to dCBT-I treatment. Metric: Percent of subjects who complete 4 out of 6 treatment modules.

  Up to 24 weeks.

• Aim 2: Investigate whether dCBT-I is safe for older adults with suicidal ideation.

  Metric: The frequency of self-reported side effects as measured by the Side Effect Rating Scale - Patient Self-Report (SERS-Pat) form. The SERS-Pat assesses 11 common side effects (with options for the patient to list others) by asking about their frequency ("Not at all", "A little more than usual", "More than usual", "Much more than usual") and their perceived relationship to treatment ("Not at all related", "Possibly related", "Probably related").

  Up to 24 weeks.

Secondary Outcomes (1)

• Aim 3: Explore whether dCBT-I can reduce suicidal ideation in older adults.

  Through study completion, an average of 1 year.

Study Arms (2)

digital Cognitive Behavioral Therapy for Insomnia

EXPERIMENTAL

Following baseline evaluation, participants in this group will receive 8 weeks of digital Cognitive Behavioral Therapy for Insomnia delivered using Sleep Healthy Using the Internet (SHUTi). After the interim assessment, participants will then crossover to 8 weeks of active monitoring.

Behavioral: Digital Cognitive Behavioral Therapy for Insomnia

Waitlist Control

NO INTERVENTION

Following baseline evaluation, participants in this group will undergo weekly monitoring of insomnia and suicidal ideation for 8 weeks. Participants will continue whatever treatments they are currently receiving, but will receive no specific instructions or behavioral interventions for insomnia. After the interim assessment, participants will then crossover to receive digital Cognitive Behavioral Therapy for Insomnia.

Interventions

Digital Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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.

Also known as: dCBT-I, SHUTi, Sleep Health Using the Internet

digital Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• MICHAEL A GRANDNER: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Banner Whole Health Clinic

Tucson, Arizona, 85711, United States

Location

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Suicidal Ideation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Michael A Grandner, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: A randomized parallel clinical trial of digital cognitive behavioral therapy for insomnia versus waitlist control with subsequent crossover to digital cognitive behavioral therapy for insomnia.

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: August 2, 2021
• Study Start: September 1, 2021
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

US (1)