Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) for Chronic Insomnia
Phase-Based Progress Estimates
Effectiveness
Safety
University of Missouri, Columbia, MOChronic Insomnia+1 MoreWeb-based Cognitive Behavior Therapy for Insomnia (CBT-I) - Behavioral
Study Summary
This trial will examine whether web-based CBT-I is efficacious in reducing insomnia and improving mood in caregivers of persons with dementia.
Eligible Conditions
- Chronic Insomnia
- Dementia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
11 Primary · 12 Secondary · Reporting Duration: 6 weeks
6 weeks
Beck Depression Inventory Second Edition (BDI- II)
Caregiver Functional Unit Scale
Cognitive Failures Questionnaire
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
Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency
Daily Electronic Sleep and Pain Diaries - Total Sleep Time
Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset
Dementia Patient's Caregiver Quality of Life Scale
Dysfunctional Attitudes/Beliefs about Sleep (DBAS)
Insomnia Severity Index
Kingston Caregiver Stress Scale
Objective Daily Sleep Actiwatch-2 - Sleep Efficiency
Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency
Objective Daily Sleep Actiwatch-2 - Total Sleep Time
Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset
Online Cognitive Assessment - Sternberg
Online Cognitive Assessment - Stroop
Online Cognitive Assessment - Wisconsin Card Sorting Task
Perceived Stress Scale (PSS)
State Trait Anxiety Inventory (STAI-Y1)
Zarit Burden Scale
Trial Safety
Trial Design
1 Treatment Group
NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia
1 of 1
Experimental Treatment
60 Total Participants · 1 Treatment Group
Primary Treatment: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) · No Placebo Group · N/A
NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia
Behavioral
Experimental Group · 1 Intervention: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
332 Previous Clinical Trials
600,751 Total Patients Enrolled
Christina McCraePrincipal Investigator - University of Missouri-Columbia
University of Missouri-Columbia
Eligibility Criteria
Age 18+ · All Participants · 12 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have trouble sleeping at night and it affects your mood, thinking ability, social life, and work performance during the day.
You have trouble sleeping based on a screening test with a score of 9 or higher.
You are a caregiver for someone with dementia and live with them.
You have been diagnosed with insomnia.
You have been experiencing symptoms for more than 6 months.
You have trouble sleeping, either with falling asleep, staying asleep, or waking up too early.
You cannot have taken any sleep medication, whether prescribed or bought over-the-counter, for at least six weeks before the trial.
You have enough time and the right conditions to get a good night's sleep.
References
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Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer