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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Sleep Initiation and Maintenance Disorders, Suicidal Ideation

Intervention / Treatment
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* Behavioral: Digital Cognitive Behavioral Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals 65 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: digital Cognitive Behavioral Therapy for Insomnia<br>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<br>* 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.<br>* Other names: Sleep Health Using the Internet;|
| No Intervention: Waitlist Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aim 1a: Evaluate whether dCBT-I is a feasible intervention for older adults with insomnia and suicidal ideation. | Subaim 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. | Subaim 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AIM 3: Explore whether dCBT-I can reduce suicidal ideation in older adults. | Measurement of changes in Columbia Suicide Severity Rating Scale (CSSRS) scores from baseline. The CSSRS measures the presence and severity of suicidal thoughts and behaviors over an individual's lifetime, prior 3 months, and since last visit/interview. Questions are either yes/no or roughly range from 0-5, with higher scores reflecting more severe symptoms. | Through study completion, an average of 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Clinical Trial, digital Cognitive Behavioral Therapy for Insomnia, Older Adults, Suicidal Ideation, Insomnia