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Behavioral Intervention

Web-Based Cognitive Behavioral Therapy for Caregiver Insomnia (NiteCAPP Trial)

N/A
Recruiting
Led By Christina McCrae
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

NiteCAPP Trial Summary

This trial will examine whether web-based CBT-I is efficacious in reducing insomnia and improving mood in caregivers of persons with dementia.

Who is the study for?
This trial is for dementia caregivers over 18, living with the person they care for. They must have insomnia lasting 6+ months, affecting their daily life, and understand English. Participants should not be on new sleep meds or have unstable medication use in the past 6 weeks.Check my eligibility
What is being tested?
The study tests a web-based Cognitive Behavioral Therapy program (WebCBT-I) called NiteCAPP designed to help dementia caregivers manage insomnia. It aims to improve sleep quality and reduce related health issues like fatigue and mood disorders.See study design
What are the potential side effects?
Since WebCBT-I is a non-medical therapy focusing on behavior changes and coping strategies, it typically doesn't cause physical side effects but may initially increase awareness of sleeping patterns or stress.

NiteCAPP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Daily Electronic Sleep and Pain Diaries - Medication Consumption
Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness
Daily Electronic Sleep and Pain Diaries - Sleep Efficiency
+8 more
Secondary outcome measures
Beck Depression Inventory Second Edition (BDI- II)
Caregiver Functional Unit Scale
Cognitive Failures Questionnaire
+9 more

NiteCAPP Trial Design

1Treatment groups
Experimental Treatment
Group I: NiteCAPP: Online Cognitive Behavioral Therapy for InsomniaExperimental Treatment1 Intervention
This is a pilot trial with one treatment condition (CBT-I).

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor
412 Previous Clinical Trials
186,999 Total Patients Enrolled
University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
628,054 Total Patients Enrolled
Christina McCraePrincipal Investigator - University of Missouri-Columbia
University of Missouri-Columbia

Media Library

Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04632628 — N/A
Chronic Insomnia Research Study Groups: NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia
Chronic Insomnia Clinical Trial 2023: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) Highlights & Side Effects. Trial Name: NCT04632628 — N/A
Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04632628 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment have open vacancies for participants?

"According to clinicaltrials.gov, this scientific investigation is actively recruiting participants since its inception on January 1st 2022 and most recently modified April 26th 2021."

Answered by AI

What is the desired outcome of this investigation?

"This 6-week trial aims to assess Objective Daily Sleep Actiwatch-2 - Sleep Efficiency as its primary objective. As secondary objectives, the study looks at three other metrics: Beck Depression Inventory Second Edition (BDI-II), Perceived Stress Scale (PSS) and Kingston Caregiver Stress Scale. The BDI II measures depressive symptoms on a scale of 0 to 63; the PSS gauges perceived stress from 0 to 40, while the KCSS evaluates caregiver stress from 10 to 50 with higher scores correlating with greater levels of both depression and stress."

Answered by AI

How many test subjects are currently enrolled in this experiment?

"Indeed, the clinicaltrials.gov website affirms that this medical trial is currently recruiting participants; it was initially published on January 1st 2022 and edited most recently April 26th 2021. The investigation requires 60 subjects to be enrolled at a single site."

Answered by AI
Recent research and studies
~28 spots leftby Mar 2026