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

Launched by MICHAEL A GRANDNER · Jul 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a specific type of online therapy called digital cognitive behavioral therapy for insomnia (dCBT-I) can help reduce suicidal thoughts in older adults who have trouble sleeping. We know that insomnia, or difficulty falling and staying asleep, can increase the risk of suicidal thoughts, especially in people aged 55 and older. The researchers want to see if treating insomnia with this online therapy can make a difference in how these patients feel.

To participate in the trial, individuals must be at least 55 years old, speak English, and currently experience insomnia along with recent thoughts of suicide. Participants will need to agree to allow the research team to communicate with their healthcare provider. However, those with certain serious mental illnesses, unstable health conditions, or specific sleep disorders may not be eligible. Participants can expect to engage in online therapy sessions that aim to improve their sleep and potentially reduce their suicidal thoughts. This study is an important step in understanding how digital therapy can help older adults facing these challenges.

Gender

ALL

Eligibility 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.