Digital therapy for insomnia and suicidal thoughts in older adults
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
This study is testing a digital therapy for insomnia to see if it can help older adults who are struggling with sleep issues and suicidal thoughts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT04986007 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to assess the feasibility and safety of digital cognitive behavioral therapy for insomnia (dCBT-I) in older adults experiencing insomnia and suicidal ideation. Participants aged 65 and older will be randomly assigned to receive either 12 weeks of dCBT-I or be placed on a waitlist control. After the initial treatment phase, those in the waitlist group will crossover to receive dCBT-I. The study will evaluate treatment adherence, safety, and potential efficacy, as well as the role of cognitive functioning in treatment response over a follow-up period of 6 to 12 months.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 and older who are experiencing insomnia and have had recent suicidal ideation.
Not a fit: Patients with serious mental illnesses such as bipolar disorder or psychotic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce suicidal thoughts and improve sleep quality in older adults.
How similar studies have performed: While there is limited evidence specifically in older adults, other studies have shown promise in using digital cognitive behavioral therapy for insomnia in various populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). 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.
Where this trial is running
Tucson, Arizona
- Banner Whole Health Clinic — Tucson, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Michael A Grandner, PhD — University of Arizona
- Study coordinator: Andrew S Tubbs, PhD
- Email: atubbs@arizona.edu
- Phone: (520) 626-6346
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.