Insomnia ChronicNiteCAPPNCT04632628
Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
A study testing Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) in people with Insomnia Chronic and Dementia, run by University of South Florida at 1 site in United States.
Trial summary
Over the next 30 years, more than 10 million persons living with dementia in the United States will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers and persons with dementia alike, but increases the caregiver's risk of insomnia and related negative health… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia Chronic, Dementia
- What is being tested?
- Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2023to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18+ yrs
- Dementia caregiver living with person with dementia
- willing to be randomized, 4. read/understand English
- insomnia diagnosis
- no prescribed or over-the-counter sleep meds or stabilized 6+ weeks.
- Insomnia:
Show all 16Show fewer
- complaints for 6+ mos
- adequate opportunity and circumstances for sleep
- 1+ of the following: difficulty falling asleep, staying asleep, or waking too early
- daytime dysfunction (mood, cognitive, social, occupational) due to insomnia
- Screening interview indicates Insomnia Severity Index score ≥11 or Insomnia Severity Index score 9-10
- baseline diaries indicate >30 mins of sleep onset latency or wake after sleep onset on 3+ nts.
- 18+ yrs
- Persons with dementia living with caregiver
- Have an eligible caregiver
- willing to be randomized
Who cannot join
- unable to consent
- cognitive impairment [Telephone Interview for Cognitive Status (TICS) <25 or Mini Mental State Examination (MMSE) <26]
- sleep disorder other than insomnia [i.e., sleep apnea (apnea/hypopnea index, AHI >15)]
- bipolar or seizure disorder
- other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychosis)
- severe untreated psychiatric comorbidity
Show all 10Show fewer
- psychotropic or other medications (e.g., beta-blockers) that alter sleep
- non-pharmacological tx for sleep or mood outside current trial.
- PERSONS WITH DEMENTIA
- Person with dementia or legally authorized representative is unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri
Columbia, Missouri, 65212
Christina McCrae
Riley Stephens
About this study
Over the next 30 years, more than 10 million persons living with dementia in the United States will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers and persons with dementia alike, but increases the caregiver's risk of insomnia and related negative health outcomes, including depression, anxiety, cognitive disturbances and poor quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is a highly effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research by our group and others suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol specifically adapted for dementia caregivers (CBT-I) and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia symptoms and improves mood (moderate to large effects). Given demands on caregivers' time and limited availability of trained CBT-I providers, a web-based version of CBT-I (WebCBT-I; the online treatment will be called NiteCAPP) is needed to increase the accessibility of this efficacious treatment. WebCBT-I will allow for flexible at home scheduling, and the skills needed to monitor caregiver treatment progress can be quickly and efficiently taught to healthcare providers. The overarching goal of this project is to develop and test WebCBT-I in caregivers of persons with dementia.
Objectives
- To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia.
- To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue.
- To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.
- To examine the mechanistic variables, including arousal (heart rate variability, HRV).
- Conditions
- Insomnia Chronic, Dementia
- Being tested
- Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)
- Keywords
- Dementia Caregiver, Sleep, Behavioral Interventions, Online Behavioral Intervention, Insomnia, Dementia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)Behavioural
Participants will complete 4 web-based CBT- I sessions. Lesson 1: Sleep Hygiene and Stimulus Control Lesson 2: Sleep Restriction and Relaxation Strategies Lesson 3: Identifying and Restructuring Dysfunction Thoughts Lesson 4: Practical Recommendations, Review, and Maintenance of Change
| Study group | Role | What they receive |
|---|---|---|
| NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia | Experimental | This is a pilot trial with one treatment condition (CBT-I). Receives: Behavioral: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency
Subjective sleep onset latency (time to fall asleep)
Measured: 6 weeks
Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset
Subjective time awake after sleep onset
Measured: 6 weeks
Daily Electronic Sleep and Pain Diaries - Total Sleep Time
Subjective total sleep time
Measured: 6 weeks
Daily Electronic Sleep and Pain Diaries - Sleep Efficiency
Subjective sleep efficiency
Measured: 6 weeks
Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness
Pain Intensity \& Unpleasantness
Measured: 6 weeks
Daily Electronic Sleep and Pain Diaries - Medication Consumption
Sleep and pain medication consumption
Measured: 6 weeks
Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency
Objective sleep onset latency (time to fall asleep)
Measured: 6 weeks
Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset
Objective time awake after sleep onset
Measured: 6 weeks
Objective Daily Sleep Actiwatch-2 - Total Sleep Time
Objective total sleep time
Measured: 6 weeks
Objective Daily Sleep Actiwatch-2 - Sleep Efficiency
Objective sleep efficiency
Measured: 6 weeks
Insomnia Severity Index
Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity
Measured: 6 weeks
Secondary outcomes (12)
State Trait Anxiety Inventory (STAI-Y1)
Assessment of anxiety symptoms - min: 0 max:60; higher score means higher anxiety
Measured: 6 weeks
Beck Depression Inventory Second Edition (BDI- II)
Depressive symptom assessment - min: 0 max: 63; Higher score means higher severity of depression
Measured: 6 weeks
Perceived Stress Scale (PSS)
Perception of stress - min: 0; max:40 - higher scores indicate higher perceived stress
Measured: 6 weeks
Kingston Caregiver Stress Scale
Caregiver stress measurement - min:10 max:50 - higher score indicates higher caregiver stress
Measured: 6 weeks
Dysfunctional Attitudes/Beliefs about Sleep (DBAS)
evaluates sleep-related beliefs, expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues - higher scores indicates more dysfunctional beliefs and attitudes
Measured: 6 weeks
Caregiver Functional Unit Scale
Assessment of the stability of the patient-caregiver dyad - higher score indicates lower stability
Measured: 6 weeks
Online Cognitive Assessment - Stroop
Determine level of cognitive functioning
Measured: 6 weeks
Online Cognitive Assessment - Sternberg
Determine level of cognitive functioning
Measured: 6 weeks
Online Cognitive Assessment - Wisconsin Card Sorting Task
Determine level of cognitive functioning
Measured: 6 weeks
Cognitive Failures Questionnaire
Self-reported failures in perception, memory, and motor function - min:0 max: 100 - higher score indicates greater cognitive failure
Measured: 6 weeks
Dementia Patient's Caregiver Quality of Life Scale
Assessment of caregiver quality of life - min: 0 max:100 - higher score indicates good quality of life
Measured: 6 weeks
Zarit Burden Scale
Caregiver burden measurement - min: 0 max: 48 - higher score indicated higher caregiver burden
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start14 Nov 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina McCrae, University of South Florida
- Investigators
- Christina McCrae, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632628
- Sponsor's protocol ID
- 2017125
- Acronym
- NiteCAPP
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2020
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rowe MA, McCrae CS, Campbell JM, Benito AP, Cheng J. Sleep pattern differences between older adult dementia caregivers and older adult noncaregivers using objective and subjective measures. J Clin Sleep Med. 2008 Aug 15;4(4):362-9.
PubMed 18763429Fonareva I, Amen AM, Zajdel DP, Ellingson RM, Oken BS. Assessing sleep architecture in dementia caregivers at home using an ambulatory polysomnographic system. J Geriatr Psychiatry Neurol. 2011 Mar;24(1):50-9. doi: 10.1177/0891988710397548.
PubMed 21320949Beaudreau SA, Spira AP, Gray HL, Depp CA, Long J, Rothkopf M, Gallagher-Thompson D. The relationship between objectively measured sleep disturbance and dementia family caregiver distress and burden. J Geriatr Psychiatry Neurol. 2008 Sep;21(3):159-65. doi: 10.1177/0891988708316857. Epub 2008 May 23.
PubMed 18503035Creese J, Bedard M, Brazil K, Chambers L. Sleep disturbances in spousal caregivers of individuals with Alzheimer's disease. Int Psychogeriatr. 2008 Feb;20(1):149-61. doi: 10.1017/S1041610207005339. Epub 2007 Apr 30.
PubMed 17466086McCurry SM, Logsdon RG, Teri L, Vitiello MV. Sleep disturbances in caregivers of persons with dementia: contributing factors and treatment implications. Sleep Med Rev. 2007 Apr;11(2):143-53. doi: 10.1016/j.smrv.2006.09.002. Epub 2007 Feb 6.
PubMed 17287134McCrae CS, Wilson NM, Lichstein KL, Durrence HH, Taylor DJ, Bush AJ, Riedel BW. 'Young old' and 'old old' poor sleepers with and without insomnia complaints. J Psychosom Res. 2003 Jan;54(1):11-9. doi: 10.1016/s0022-3999(02)00543-3.
PubMed 12505551Mahoney DF. Vigilance. Evolution and definition for caregivers of family members with Alzheimer's disease. J Gerontol Nurs. 2003 Aug;29(8):24-30. doi: 10.3928/0098-9134-20030801-07.
PubMed 13677157McCrae CS, Curtis AF, Williams JM, Dautovich ND, McNamara JPH, Stripling A, Dzierzewski JM, Chan WS, Berry RB, McCoy KJM, Marsiske M. Efficacy of brief behavioral treatment for insomnia in older adults: examination of sleep, mood, and cognitive outcomes. Sleep Med. 2018 Nov;51:153-166. doi: 10.1016/j.sleep.2018.05.018. Epub 2018 Jun 2.
PubMed 30195661Edinger JD, Wohlgemuth WK, Krystal AD, Rice JR. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. Arch Intern Med. 2005 Nov 28;165(21):2527-35. doi: 10.1001/archinte.165.21.2527.
PubMed 16314551McCrae CS, McGovern R, Lukefahr R, Stripling AM. Research Evaluating Brief Behavioral Sleep Treatments for Rural Elderly (RESTORE): a preliminary examination of effectiveness. Am J Geriatr Psychiatry. 2007 Nov;15(11):979-82. doi: 10.1097/JGP.0b013e31813547e6.
PubMed 17974868Glass J, Lanctot KL, Herrmann N, Sproule BA, Busto UE. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ. 2005 Nov 19;331(7526):1169. doi: 10.1136/bmj.38623.768588.47. Epub 2005 Nov 11.
PubMed 16284208Allain H, Bentue-Ferrer D, Polard E, Akwa Y, Patat A. Postural instability and consequent falls and hip fractures associated with use of hypnotics in the elderly: a comparative review. Drugs Aging. 2005;22(9):749-65. doi: 10.2165/00002512-200522090-00004.
PubMed 16156679Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841.
PubMed 26054060Bertisch SM, Herzig SJ, Winkelman JW, Buettner C. National use of prescription medications for insomnia: NHANES 1999-2010. Sleep. 2014 Feb 1;37(2):343-9. doi: 10.5665/sleep.3410.
PubMed 24497662Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2):125-33. doi: 10.7326/M15-2175. Epub 2016 May 3.
PubMed 27136449
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
- ClinicalTrials.gov ID
- NCT04632628
- Acronym / sponsor ID
- NiteCAPP / 2017125
- Conditions
- Insomnia Chronic, Dementia
- Keywords
- Dementia Caregiver, Sleep, Behavioral Interventions, Online Behavioral Intervention, Insomnia, Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 17 Nov 2020 (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.
Over the next 30 years, more than 10 million persons living with dementia in the United States will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers and persons with dementia alike, but increases the caregiver's risk of insomnia and related negative health outcomes, including depression, anxiety, cognitive disturbances and poor quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is a highly effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research by our group and others suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol specifically adapted for dementia caregivers (CBT-I) and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia symptoms and improves mood (moderate to large effects). Given demands on caregivers' time and limited availability of trained CBT-I providers, a web-based version of CBT-I (WebCBT-I; the online treatment will be called NiteCAPP) is needed to increase the accessibility of this efficacious treatment. WebCBT-I will allow for flexible at home scheduling, and the skills needed to monitor caregiver treatment progress can be quickly and efficiently taught to healthcare providers. The overarching goal of this project is to develop and test WebCBT-I in caregivers of persons with dementia.
Objectives
- To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia.
- To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue.
- To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.
- To examine the mechanistic variables, including arousal (heart rate variability, HRV).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia | Experimental | Behavioral: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)This is a pilot trial with one treatment condition (CBT-I). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 18+ yrs
- Dementia caregiver living with person with dementia
- willing to be randomized, 4. read/understand English
- insomnia diagnosis
- no prescribed or over-the-counter sleep meds or stabilized 6+ weeks.
Key exclusion criteria (10 listed)
- unable to consent
- cognitive impairment [Telephone Interview for Cognitive Status (TICS) <25 or Mini Mental State Examination (MMSE) <26]
- sleep disorder other than insomnia [i.e., sleep apnea (apnea/hypopnea index, AHI >15)]
- bipolar or seizure disorder
- other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychosis)
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 |
|---|---|---|
| Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)Participants will complete 4 web-based CBT- I sessions. Lesson 1: Sleep Hygiene and Stimulus Control Lesson 2: Sleep Restriction and Relaxation Strategies Lesson 3: Identifying and Restructuring Dysfunction Thoughts Lesson 4: Practical Recommendations, Review, and Maintenance of Change | Behavioural | NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia |
Primary outcome
Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency
Time frame: 6 weeks
Subjective sleep onset latency (time to fall asleep)
Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset
Time frame: 6 weeks
Subjective time awake after sleep onset
Daily Electronic Sleep and Pain Diaries - Total Sleep Time
Time frame: 6 weeks
Subjective total sleep time
Daily Electronic Sleep and Pain Diaries - Sleep Efficiency
Time frame: 6 weeks
Subjective sleep efficiency
Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness
Time frame: 6 weeks
Pain Intensity \& Unpleasantness
Daily Electronic Sleep and Pain Diaries - Medication Consumption
Time frame: 6 weeks
Sleep and pain medication consumption
Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency
Time frame: 6 weeks
Objective sleep onset latency (time to fall asleep)
Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset
Time frame: 6 weeks
Objective time awake after sleep onset
Objective Daily Sleep Actiwatch-2 - Total Sleep Time
Time frame: 6 weeks
Objective total sleep time
Objective Daily Sleep Actiwatch-2 - Sleep Efficiency
Time frame: 6 weeks
Objective sleep efficiency
Insomnia Severity Index
Time frame: 6 weeks
Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity
12 secondary outcomes
State Trait Anxiety Inventory (STAI-Y1)
Time frame: 6 weeks
Beck Depression Inventory Second Edition (BDI- II)
Time frame: 6 weeks
Perceived Stress Scale (PSS)
Time frame: 6 weeks
Kingston Caregiver Stress Scale
Time frame: 6 weeks
Dysfunctional Attitudes/Beliefs about Sleep (DBAS)
Time frame: 6 weeks
Caregiver Functional Unit Scale
Time frame: 6 weeks
Online Cognitive Assessment - Stroop
Time frame: 6 weeks
Online Cognitive Assessment - Sternberg
Time frame: 6 weeks
Online Cognitive Assessment - Wisconsin Card Sorting Task
Time frame: 6 weeks
Cognitive Failures Questionnaire
Time frame: 6 weeks
Dementia Patient's Caregiver Quality of Life Scale
Time frame: 6 weeks
Zarit Burden Scale
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 18763429Rowe MA, McCrae CS, Campbell JM, Benito AP, Cheng J. Sleep pattern differences between older adult dementia caregivers and older adult noncaregivers using objective and subjective measures. J Clin Sleep Med. 2008 Aug 15;4(4):362-9.
- Background: PubMed 21320949Fonareva I, Amen AM, Zajdel DP, Ellingson RM, Oken BS. Assessing sleep architecture in dementia caregivers at home using an ambulatory polysomnographic system. J Geriatr Psychiatry Neurol. 2011 Mar;24(1):50-9. doi: 10.1177/0891988710397548.
- Background: PubMed 18503035Beaudreau SA, Spira AP, Gray HL, Depp CA, Long J, Rothkopf M, Gallagher-Thompson D. The relationship between objectively measured sleep disturbance and dementia family caregiver distress and burden. J Geriatr Psychiatry Neurol. 2008 Sep;21(3):159-65. doi: 10.1177/0891988708316857. Epub 2008 May 23.
- Background: PubMed 17466086Creese J, Bedard M, Brazil K, Chambers L. Sleep disturbances in spousal caregivers of individuals with Alzheimer's disease. Int Psychogeriatr. 2008 Feb;20(1):149-61. doi: 10.1017/S1041610207005339. Epub 2007 Apr 30.
- Background: PubMed 17287134McCurry SM, Logsdon RG, Teri L, Vitiello MV. Sleep disturbances in caregivers of persons with dementia: contributing factors and treatment implications. Sleep Med Rev. 2007 Apr;11(2):143-53. doi: 10.1016/j.smrv.2006.09.002. Epub 2007 Feb 6.
- Background: PubMed 12505551McCrae CS, Wilson NM, Lichstein KL, Durrence HH, Taylor DJ, Bush AJ, Riedel BW. 'Young old' and 'old old' poor sleepers with and without insomnia complaints. J Psychosom Res. 2003 Jan;54(1):11-9. doi: 10.1016/s0022-3999(02)00543-3.
- Background: PubMed 13677157Mahoney DF. Vigilance. Evolution and definition for caregivers of family members with Alzheimer's disease. J Gerontol Nurs. 2003 Aug;29(8):24-30. doi: 10.3928/0098-9134-20030801-07.
- Background: PubMed 30195661McCrae CS, Curtis AF, Williams JM, Dautovich ND, McNamara JPH, Stripling A, Dzierzewski JM, Chan WS, Berry RB, McCoy KJM, Marsiske M. Efficacy of brief behavioral treatment for insomnia in older adults: examination of sleep, mood, and cognitive outcomes. Sleep Med. 2018 Nov;51:153-166. doi: 10.1016/j.sleep.2018.05.018. Epub 2018 Jun 2.
- Background: PubMed 16314551Edinger JD, Wohlgemuth WK, Krystal AD, Rice JR. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. Arch Intern Med. 2005 Nov 28;165(21):2527-35. doi: 10.1001/archinte.165.21.2527.
- Background: PubMed 17974868McCrae CS, McGovern R, Lukefahr R, Stripling AM. Research Evaluating Brief Behavioral Sleep Treatments for Rural Elderly (RESTORE): a preliminary examination of effectiveness. Am J Geriatr Psychiatry. 2007 Nov;15(11):979-82. doi: 10.1097/JGP.0b013e31813547e6.
- Background: PubMed 16284208Glass J, Lanctot KL, Herrmann N, Sproule BA, Busto UE. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ. 2005 Nov 19;331(7526):1169. doi: 10.1136/bmj.38623.768588.47. Epub 2005 Nov 11.
- Background: PubMed 16156679Allain H, Bentue-Ferrer D, Polard E, Akwa Y, Patat A. Postural instability and consequent falls and hip fractures associated with use of hypnotics in the elderly: a comparative review. Drugs Aging. 2005;22(9):749-65. doi: 10.2165/00002512-200522090-00004.
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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.
Christina McCrae principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) in people with Insomnia Chronic and Dementia, run by University of South Florida 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 16 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina S McCrae (573-882-0982, mccraec@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency (time frame: 6 weeks). The study lists 11 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 NCT04632628, which also lists 47 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 15 Jun 2026.