Sleep Initiation and Maintenance DisordersANSWERS-OANCT04986007
Addressing Nocturnal Sleep/Wake Effects on Risk of Suicide in Older Adults
A study testing Digital Cognitive Behavioral Therapy for Insomnia in people with Sleep Initiation and Maintenance Disorders and Suicidal Ideation, run by MICHAEL A GRANDNER at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Suicidal Ideation
- What is being tested?
- Digital Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 22 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Being tested
- Digital Cognitive Behavioral Therapy for Insomnia
- Keywords
- Randomized Clinical Trial, digital Cognitive Behavioral Therapy for Insomnia, Older Adults, Suicidal Ideation, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Cognitive Behavioral Therapy for InsomniaBehavioural
Also called dCBT-I, SHUTi, Sleep Health Using the Internet
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.
| Study group | Role | What they receive |
|---|---|---|
| digital Cognitive Behavioral Therapy for Insomnia | Experimental | 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. Receives: Behavioral: Digital Cognitive Behavioral Therapy for Insomnia |
| Waitlist Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Aim 1a: Evaluate whether dCBT-I is a feasible intervention for older adults with insomnia and suicidal ideation.
Sub-aim 1a: Determine participant engagement with 10 weeks of dCBT-I. Metric: Percent of subjects enrolled who complete the 10 week treatment period
Measured: Up to 24 weeks.
Aim 1b: Evaluate whether dCBT-I is a feasible intervention for older adults with insomnia and suicidal ideation.
Sub-aim 1b: Measure participant adherence to dCBT-I treatment. Metric: Percent of subjects who complete 4 out of 6 treatment modules.
Measured: 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").
Measured: Up to 24 weeks.
Secondary outcomes (1)
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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Sep 2021
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Why it stopped: Recruitment failure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (67)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- MICHAEL A GRANDNER
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor-investigator, MICHAEL A GRANDNER, University of Arizona
- Investigators
- Michael A Grandner, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986007
- Sponsor's protocol ID
- ANSWERS-OA
- Acronym
- ANSWERS-OA
- Status last verified
- Aug 2025
- First submitted
- 24 May 2021
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pigeon WR, Pinquart M, Conner K. Meta-analysis of sleep disturbance and suicidal thoughts and behaviors. J Clin Psychiatry. 2012 Sep;73(9):e1160-7. doi: 10.4088/JCP.11r07586.
PubMed 23059158Bernert RA, Kim JS, Iwata NG, Perlis ML. Sleep disturbances as an evidence-based suicide risk factor. Curr Psychiatry Rep. 2015 Mar;17(3):554. doi: 10.1007/s11920-015-0554-4.
PubMed 25698339Harris LM, Huang X, Linthicum KP, Bryen CP, Ribeiro JD. Sleep disturbances as risk factors for suicidal thoughts and behaviours: a meta-analysis of longitudinal studies. Sci Rep. 2020 Aug 17;10(1):13888. doi: 10.1038/s41598-020-70866-6.
PubMed 32807889Liu RT, Steele SJ, Hamilton JL, Do QBP, Furbish K, Burke TA, Martinez AP, Gerlus N. Sleep and suicide: A systematic review and meta-analysis of longitudinal studies. Clin Psychol Rev. 2020 Nov;81:101895. doi: 10.1016/j.cpr.2020.101895. Epub 2020 Aug 8.
PubMed 32801085Zuromski KL, Cero I, Witte TK. Insomnia symptoms drive changes in suicide ideation: A latent difference score model of community adults over a brief interval. J Abnorm Psychol. 2017 Aug;126(6):739-749. doi: 10.1037/abn0000282. Epub 2017 May 29.
PubMed 28557509Hedstrom AK, Hossjer O, Bellocco R, Ye W, Trolle LY, Akerstedt T. Insomnia in the context of short sleep increases suicide risk. Sleep. 2021 Apr 9;44(4):zsaa245. doi: 10.1093/sleep/zsaa245.
PubMed 33216134Wang HE, Campbell-Sills L, Kessler RC, Sun X, Heeringa SG, Nock MK, Ursano RJ, Jain S, Stein MB. Pre-deployment insomnia is associated with post-deployment post-traumatic stress disorder and suicidal ideation in US Army soldiers. Sleep. 2019 Feb 1;42(2):zsy229. doi: 10.1093/sleep/zsy229.
PubMed 30508139Rossler W, Angst J, Ajdacic-Gross V, Haker H, Berrouiguet S, Ujeyl M, Glozier N, Hengartner MP. Sleep Disturbances and Suicidality-A Longitudinal Analysis From a Representative Community Study Over 30 Years. Front Psychiatry. 2018 Jul 16;9:320. doi: 10.3389/fpsyt.2018.00320. eCollection 2018.
PubMed 30061849Ferentinos P, Porichi E, Christodoulou C, Dikeos D, Papageorgiou C, Douzenis A. Sleep disturbance as a proximal predictor of suicidal intent in recently hospitalized attempters. Sleep Med. 2016 Mar;19:1-7. doi: 10.1016/j.sleep.2015.10.021. Epub 2015 Nov 24.
PubMed 27198939Li SX, Lam SP, Yu MW, Zhang J, Wing YK. Nocturnal sleep disturbances as a predictor of suicide attempts among psychiatric outpatients: a clinical, epidemiologic, prospective study. J Clin Psychiatry. 2010 Nov;71(11):1440-6. doi: 10.4088/JCP.09m05661gry.
PubMed 21114949Lin HT, Lai CH, Perng HJ, Chung CH, Wang CC, Chen WL, Chien WC. Insomnia as an independent predictor of suicide attempts: a nationwide population-based retrospective cohort study. BMC Psychiatry. 2018 May 2;18(1):117. doi: 10.1186/s12888-018-1702-2.
PubMed 29716570Fujino Y, Mizoue T, Tokui N, Yoshimura T. Prospective cohort study of stress, life satisfaction, self-rated health, insomnia, and suicide death in Japan. Suicide Life Threat Behav. 2005 Apr;35(2):227-37. doi: 10.1521/suli.35.2.227.62876.
PubMed 15843339Perlis ML, Grandner MA, Chakravorty S, Bernert RA, Brown GK, Thase ME. Suicide and sleep: Is it a bad thing to be awake when reason sleeps? Sleep Med Rev. 2016 Oct;29:101-7. doi: 10.1016/j.smrv.2015.10.003. Epub 2015 Oct 19.
PubMed 26706755Perlis ML, Grandner MA, Brown GK, Basner M, Chakravorty S, Morales KH, Gehrman PR, Chaudhary NS, Thase ME, Dinges DF. Nocturnal Wakefulness as a Previously Unrecognized Risk Factor for Suicide. J Clin Psychiatry. 2016 Jun;77(6):e726-33. doi: 10.4088/JCP.15m10131.
PubMed 27337421Tubbs AS, Perlis ML, Basner M, Chakravorty S, Khader W, Fernandez F, Grandner MA. Relationship of Nocturnal Wakefulness to Suicide Risk Across Months and Methods of Suicide. J Clin Psychiatry. 2020 Feb 25;81(2):19m12964. doi: 10.4088/JCP.19m12964.
PubMed 32097547
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04986007
- Acronym / sponsor ID
- ANSWERS-OA / ANSWERS-OA
- Keywords
- Randomized Clinical Trial, digital Cognitive Behavioral Therapy for Insomnia, Older Adults, Suicidal Ideation, Insomnia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment failure.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- MICHAEL A GRANDNERUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| digital Cognitive Behavioral Therapy for Insomnia | Experimental | Behavioral: Digital Cognitive Behavioral Therapy for InsomniaFollowing 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. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Cognitive Behavioral Therapy for InsomniaAlso: dCBT-I, SHUTi, Sleep Health Using the InternetDigital 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. | Behavioural | digital Cognitive Behavioral Therapy for Insomnia |
Primary outcome
Aim 1a: Evaluate whether dCBT-I is a feasible intervention for older adults with insomnia and suicidal ideation.
Time frame: Up to 24 weeks.
Sub-aim 1a: Determine participant engagement with 10 weeks of dCBT-I. Metric: Percent of subjects enrolled who complete the 10 week treatment period
Aim 1b: Evaluate whether dCBT-I is a feasible intervention for older adults with insomnia and suicidal ideation.
Time frame: Up to 24 weeks.
Sub-aim 1b: Measure participant adherence to dCBT-I treatment. Metric: Percent of subjects who complete 4 out of 6 treatment modules.
Aim 2: Investigate whether dCBT-I is safe for older adults with suicidal ideation.
Time frame: Up to 24 weeks.
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").
1 secondary outcome
Aim 3: Explore whether dCBT-I can reduce suicidal ideation in older adults.
Time frame: Through study completion, an average of 1 year.
Results and safety
The study was stopped early (reason given: Recruitment failure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Background: PubMed 23059158Pigeon WR, Pinquart M, Conner K. Meta-analysis of sleep disturbance and suicidal thoughts and behaviors. J Clin Psychiatry. 2012 Sep;73(9):e1160-7. doi: 10.4088/JCP.11r07586.
- Background: PubMed 25698339Bernert RA, Kim JS, Iwata NG, Perlis ML. Sleep disturbances as an evidence-based suicide risk factor. Curr Psychiatry Rep. 2015 Mar;17(3):554. doi: 10.1007/s11920-015-0554-4.
- Background: PubMed 32807889Harris LM, Huang X, Linthicum KP, Bryen CP, Ribeiro JD. Sleep disturbances as risk factors for suicidal thoughts and behaviours: a meta-analysis of longitudinal studies. Sci Rep. 2020 Aug 17;10(1):13888. doi: 10.1038/s41598-020-70866-6.
- Background: PubMed 32801085Liu RT, Steele SJ, Hamilton JL, Do QBP, Furbish K, Burke TA, Martinez AP, Gerlus N. Sleep and suicide: A systematic review and meta-analysis of longitudinal studies. Clin Psychol Rev. 2020 Nov;81:101895. doi: 10.1016/j.cpr.2020.101895. Epub 2020 Aug 8.
- Background: PubMed 28557509Zuromski KL, Cero I, Witte TK. Insomnia symptoms drive changes in suicide ideation: A latent difference score model of community adults over a brief interval. J Abnorm Psychol. 2017 Aug;126(6):739-749. doi: 10.1037/abn0000282. Epub 2017 May 29.
- Background: PubMed 33216134Hedstrom AK, Hossjer O, Bellocco R, Ye W, Trolle LY, Akerstedt T. Insomnia in the context of short sleep increases suicide risk. Sleep. 2021 Apr 9;44(4):zsaa245. doi: 10.1093/sleep/zsaa245.
- Background: PubMed 30508139Wang HE, Campbell-Sills L, Kessler RC, Sun X, Heeringa SG, Nock MK, Ursano RJ, Jain S, Stein MB. Pre-deployment insomnia is associated with post-deployment post-traumatic stress disorder and suicidal ideation in US Army soldiers. Sleep. 2019 Feb 1;42(2):zsy229. doi: 10.1093/sleep/zsy229.
- Background: PubMed 30061849Rossler W, Angst J, Ajdacic-Gross V, Haker H, Berrouiguet S, Ujeyl M, Glozier N, Hengartner MP. Sleep Disturbances and Suicidality-A Longitudinal Analysis From a Representative Community Study Over 30 Years. Front Psychiatry. 2018 Jul 16;9:320. doi: 10.3389/fpsyt.2018.00320. eCollection 2018.
- Background: PubMed 27198939Ferentinos P, Porichi E, Christodoulou C, Dikeos D, Papageorgiou C, Douzenis A. Sleep disturbance as a proximal predictor of suicidal intent in recently hospitalized attempters. Sleep Med. 2016 Mar;19:1-7. doi: 10.1016/j.sleep.2015.10.021. Epub 2015 Nov 24.
- Background: PubMed 21114949Li SX, Lam SP, Yu MW, Zhang J, Wing YK. Nocturnal sleep disturbances as a predictor of suicide attempts among psychiatric outpatients: a clinical, epidemiologic, prospective study. J Clin Psychiatry. 2010 Nov;71(11):1440-6. doi: 10.4088/JCP.09m05661gry.
- Background: PubMed 29716570Lin HT, Lai CH, Perng HJ, Chung CH, Wang CC, Chen WL, Chien WC. Insomnia as an independent predictor of suicide attempts: a nationwide population-based retrospective cohort study. BMC Psychiatry. 2018 May 2;18(1):117. doi: 10.1186/s12888-018-1702-2.
- Background: PubMed 15843339Fujino Y, Mizoue T, Tokui N, Yoshimura T. Prospective cohort study of stress, life satisfaction, self-rated health, insomnia, and suicide death in Japan. Suicide Life Threat Behav. 2005 Apr;35(2):227-37. doi: 10.1521/suli.35.2.227.62876.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Grandner, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Cognitive Behavioral Therapy for Insomnia in people with Sleep Initiation and Maintenance Disorders and Suicidal Ideation, run by MICHAEL A GRANDNER at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment failure.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1a: Evaluate whether dCBT-I is a feasible intervention for older adults with insomnia and suicidal ideation. (time frame: Up to 24 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04986007, which also lists 67 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.