Addressing Nocturnal Sleep/Wake Effects on Risk of Suicide in Older Adults — ANSWERS-OA  

Suicidal Ideation Clinical Trial

Official title: Addressing Nocturnal Sleep/Wake Effects on Risk of Suicide in Older Adults (ANSWERS-OA): A Pilot, Open-Label, Randomized Controlled Trial of Digital Cognitive Behavioral Therapy for Insomnia

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The primary goal of this pilot trial is to establish the feasibility and preliminary safety of implementing dCBT-I in older adults with insomnia and suicidal ideation. Secondary goals include estimating the potential efficacy and durability of dCBT-I for insomnia and suicidal ideation in this population, as well as evaluating neurocognitive functioning as a mediator/moderator of treatment response. To accomplish this, individuals 65 and older with insomnia and recent suicidal ideation will be recruited to either 12 weeks of treatment (dCBT-I) or waitlist control (WLC). After completion of dCBT-I, individuals in WLC will crossover to dCBT-I (WLC + dCBT-I). All participants will be re-evaluated at 6- and 12-months post-treatment.

The primary aims for this project are as follows:

Aim 1: Evaluate whether dCBT-I is a feasible intervention for older adults with insomnia and suicidal ideation. This will be assessed by subject participation and adherence to dCBT-I, evaluation of technological or cognitive barriers to accessing treatment, and by recruitment and dropout outcomes.

Aim 2: Investigate whether dCBT-I is safe for older adults with suicidal ideation. This will be measured by comparing post-treatment insomnia, depression, anxiety, and cognitive outcomes and spontaneous adverse event reports between dCBT-I and WLC, as well as post-treatment responses to the Side Effect Rating Scale - Patient Self Report (SERS-Pat) form.

The secondary aims for this project are as follows:

Aim 3: Explore whether dCBT-I can reduce suicidal ideation in older adults. While the investigators anticipate that dCBT-I will reduce suicidal ideation in older adults with insomnia, gathering preliminary data for effect size estimates will allow us to appropriately power future studies. Suicidal ideation will be measured pre-/post-treatment using the Columbia Suicide Severity Rating Scale (CSSRS) as well as weekly throughout treatment using self-report ratings of suicidal ideation severity. Comparisons will be dCBT-I vs. WLC (between groups) and WLC vs. WLC + dCBT-I (within group) using linear mixed-effects or generalized estimating equations models.

Aim 4: Assess the durability of dCBT-I treatment on suicidal ideation in older adults. Based on follow-up assessments at 6- and 12-months, the investigators will assess the potential duration of sustained improvement in suicidal ideation following dCBT-I in older adults, and how this is related to concurrent sleep continuity and quality.

Aim 5: Investigate whether changes in sleep and suicidal ideation during dCBT-I are associated with changes in neurocognition. Neurocognitive functioning will be formally assessed pre- and post-treatment using the NeuroCognitive Performance Test, a web-based neuropsychological assessment. Additionally, weekly assessment of response inhibition will occur using the Color Match task implemented as part of the same system. ;

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders
• Suicidal Ideation
• Suicide

• NCT number: NCT04986007
• Study type: Interventional
• Source: University of Arizona
• Contact: Andrew S Tubbs, PhD
• Phone: (520) 626-6346
• Email: atubbs@arizona.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Completion date: September 1, 2025