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Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers (NiteCAPP)

Primary Purpose

Insomnia Chronic, Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Chronic focused on measuring Dementia Caregiver, Sleep, Behavioral Interventions, Online Behavioral Intervention, Insomnia, Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

CAREGIVER

Inclusion Criteria:

  • 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:

  • 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:

  • 18+ yrs
  • 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

Sites / Locations

  • University of MissouriRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia

Arm Description

This is a pilot trial with one treatment condition (CBT-I).

Outcomes

Primary Outcome Measures

Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency
Subjective sleep onset latency (time to fall asleep)
Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset
Subjective time awake after sleep onset
Daily Electronic Sleep and Pain Diaries - Total Sleep Time
Subjective total sleep time
Daily Electronic Sleep and Pain Diaries - Sleep Efficiency
Subjective sleep efficiency
Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness
Pain Intensity & Unpleasantness
Daily Electronic Sleep and Pain Diaries - Medication Consumption
Sleep and pain medication consumption
Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency
Objective sleep onset latency (time to fall asleep)
Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset
Objective time awake after sleep onset
Objective Daily Sleep Actiwatch-2 - Total Sleep Time
Objective total sleep time
Objective Daily Sleep Actiwatch-2 - Sleep Efficiency
Objective sleep efficiency
Insomnia Severity Index
Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity

Secondary Outcome Measures

State Trait Anxiety Inventory (STAI-Y1)
Assessment of anxiety symptoms - min: 0 max:60; higher score means higher anxiety
Beck Depression Inventory Second Edition (BDI- II)
Depressive symptom assessment - min: 0 max: 63; Higher score means higher severity of depression
Perceived Stress Scale (PSS)
Perception of stress - min: 0; max:40 - higher scores indicate higher perceived stress
Kingston Caregiver Stress Scale
Caregiver stress measurement - min:10 max:50 - higher score indicates higher caregiver stress
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
Caregiver Functional Unit Scale
Assessment of the stability of the patient-caregiver dyad - higher score indicates lower stability
Online Cognitive Assessment - Stroop
Determine level of cognitive functioning
Online Cognitive Assessment - Sternberg
Determine level of cognitive functioning
Online Cognitive Assessment - Wisconsin Card Sorting Task
Determine level of cognitive functioning
Cognitive Failures Questionnaire
Self-reported failures in perception, memory, and motor function - min:0 max: 100 - higher score indicates greater cognitive failure
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
Zarit Burden Scale
Caregiver burden measurement - min: 0 max: 48 - higher score indicated higher caregiver burden

Full Information

First Posted
November 10, 2020
Last Updated
April 26, 2021
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04632628
Brief Title
Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
Acronym
NiteCAPP
Official Title
Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Chronic, Dementia
Keywords
Dementia Caregiver, Sleep, Behavioral Interventions, Online Behavioral Intervention, Insomnia, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia
Arm Type
Experimental
Arm Description
This is a pilot trial with one treatment condition (CBT-I).
Intervention Type
Behavioral
Intervention Name(s)
Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)
Intervention Description
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
Primary Outcome Measure Information:
Title
Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency
Description
Subjective sleep onset latency (time to fall asleep)
Time Frame
6 weeks
Title
Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset
Description
Subjective time awake after sleep onset
Time Frame
6 weeks
Title
Daily Electronic Sleep and Pain Diaries - Total Sleep Time
Description
Subjective total sleep time
Time Frame
6 weeks
Title
Daily Electronic Sleep and Pain Diaries - Sleep Efficiency
Description
Subjective sleep efficiency
Time Frame
6 weeks
Title
Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness
Description
Pain Intensity & Unpleasantness
Time Frame
6 weeks
Title
Daily Electronic Sleep and Pain Diaries - Medication Consumption
Description
Sleep and pain medication consumption
Time Frame
6 weeks
Title
Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency
Description
Objective sleep onset latency (time to fall asleep)
Time Frame
6 weeks
Title
Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset
Description
Objective time awake after sleep onset
Time Frame
6 weeks
Title
Objective Daily Sleep Actiwatch-2 - Total Sleep Time
Description
Objective total sleep time
Time Frame
6 weeks
Title
Objective Daily Sleep Actiwatch-2 - Sleep Efficiency
Description
Objective sleep efficiency
Time Frame
6 weeks
Title
Insomnia Severity Index
Description
Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
State Trait Anxiety Inventory (STAI-Y1)
Description
Assessment of anxiety symptoms - min: 0 max:60; higher score means higher anxiety
Time Frame
6 weeks
Title
Beck Depression Inventory Second Edition (BDI- II)
Description
Depressive symptom assessment - min: 0 max: 63; Higher score means higher severity of depression
Time Frame
6 weeks
Title
Perceived Stress Scale (PSS)
Description
Perception of stress - min: 0; max:40 - higher scores indicate higher perceived stress
Time Frame
6 weeks
Title
Kingston Caregiver Stress Scale
Description
Caregiver stress measurement - min:10 max:50 - higher score indicates higher caregiver stress
Time Frame
6 weeks
Title
Dysfunctional Attitudes/Beliefs about Sleep (DBAS)
Description
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
Time Frame
6 weeks
Title
Caregiver Functional Unit Scale
Description
Assessment of the stability of the patient-caregiver dyad - higher score indicates lower stability
Time Frame
6 weeks
Title
Online Cognitive Assessment - Stroop
Description
Determine level of cognitive functioning
Time Frame
6 weeks
Title
Online Cognitive Assessment - Sternberg
Description
Determine level of cognitive functioning
Time Frame
6 weeks
Title
Online Cognitive Assessment - Wisconsin Card Sorting Task
Description
Determine level of cognitive functioning
Time Frame
6 weeks
Title
Cognitive Failures Questionnaire
Description
Self-reported failures in perception, memory, and motor function - min:0 max: 100 - higher score indicates greater cognitive failure
Time Frame
6 weeks
Title
Dementia Patient's Caregiver Quality of Life Scale
Description
Assessment of caregiver quality of life - min: 0 max:100 - higher score indicates good quality of life
Time Frame
6 weeks
Title
Zarit Burden Scale
Description
Caregiver burden measurement - min: 0 max: 48 - higher score indicated higher caregiver burden
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
CAREGIVER Inclusion Criteria: 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: 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: 18+ yrs 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina S McCrae
Phone
573-882-0982
Email
mccraec@health.missouri.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Riley Stephens
Phone
573-882-8881
Email
rstephens@health.missouri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina McCrae
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina McCrae
First Name & Middle Initial & Last Name & Degree
Riley Stephens

12. IPD Sharing Statement

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Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

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