TERMINATED

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

Conditions

Sleep Initiation and Maintenance Disorders Suicidal Ideation Randomized Clinical Trial digital Cognitive Behavioral Therapy for Insomnia Older Adults Insomnia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-09-01

Study Completion:2025-07-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04986007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Principal Investigator

Michael A Grandner, PhD

PRINCIPAL_INVESTIGATOR

University of Arizona

Study Locations (Sites)

Banner Whole Health Clinic

Tucson, Arizona, 85711

United States

Collaborators and Investigators

Sponsor: MICHAEL A GRANDNER

Michael A Grandner, PhD, PRINCIPAL_INVESTIGATOR, University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-01

Study Completion Date2025-07-22

Study Record Updates

Study Start Date2021-09-01

Study Completion Date2025-07-22

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Sleep Initiation and Maintenance Disorders
Suicidal Ideation