Columbia, MONCT04632628Now EnrollingIRB Ready

Insomnia Chronic Clinical Trial in Columbia, MO

Access cutting-edge insomnia chronic treatment through this clinical trial at a research site in Columbia. Study-provided care at no cost to qualified participants.

Sponsored by University of South Florida

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Expert Care in Columbia

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related insomnia chronic treatment provided free

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Check if you qualify for this insomnia chronic clinical trial in Columbia, MO

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Columbia

    Convenient for MO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Columbia site if eligible
  4. 4Begin participation

About This Insomnia Chronic Study in Columbia

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 1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia. 2. To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue. 3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health. 4. To examine the mechanistic variables, including arousal (heart rate variability, HRV).

Sponsor: University of South Florida

Who Can Participate

Inclusion Criteria

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:
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.

Exclusion Criteria

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
psychotropic or other medications (e.g., beta-blockers) that alter sleep
non-pharmacological tx for sleep or mood outside current trial. PERSONS WITH DEMENTIA Inclusion Criteria:
Persons with dementia living with caregiver
Have an eligible caregiver
willing to be randomized Exclusion Criteria: • Person with dementia or legally authorized representative is unable to consent

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Columbia?

Yes, this clinical trial (NCT04632628) has an active research site in Columbia, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Insomnia Chronic Treatment Options in Columbia, MO

If you're searching for insomnia chronic treatment options in Columbia, MO, this clinical trial (NCT04632628) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Columbia research site is actively enrolling participants for this clinical trial. You'll receive care from experienced insomnia chronic specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all insomnia chronic clinical trials near you to find additional studies recruiting in your area.

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