Recruiting

Web-based Interventions

Sponsor:

University of South Florida

Code:

NCT04896775

Conditions

Insomnia

Dementia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NiteCAPP CARES

NiteCAPP SHARES

Study Details

Brief summary:

The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.

Conditions

Insomnia

Dementia

Study ID

NCT04896775

Start date

Feb 2, 2022

Status verified date

Apr, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion:

Caregiver Eligibility. Inclusion criteria: 1. 18+ yrs, 2. CG living with PWD, 3. willing to be randomized, 4. read/understand English, 5. insomnia diagnosis, 6. no prescribed or over the counter sleep meds for 1+ mo, or stabilized 6+ mos.

  • Insomnia: 1. complaints for 6+ mos, 2. adequate opportunity and circumstances for sleep, 3. 1+ of the following: difficulty falling asleep, staying asleep or waking too early, 4. daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, 5. baseline diaries indicate >30 mins of sleep onset latency or wake after sleep onset on 3+ nts.

PWD Eligibility. 1. probable/possible Alzheimer's Disease (self-report or primary care provider written confirm), 2. 1+ problem on Nighttime Behavior Inv. 3+ nts/wk, 3. tolerate actigraphy, 4. no sleep meds 1+ mo or stabilized 6+ mos, 5. untreated sleep disorder for which CBT-I is not recommended (e.g., apnea), 6. scoring <32 on Sleep Apnea scale, Sleep Disorders Ques.

Exclusion:

CG Exclusion criteria: 1. unable to consent, 2. cognitive impairment \[Telephone Interview for Cognitive Status (TICS) <25\], 3. sleep disorder other than insomnia \[i.e., apnea (apnea/hypopnea index-AHI >15)\], 4. bipolar or seizure disorder, 5. other major psychopathology except depression or anxiety (e.g., suicidal, psychotic), 6. severe untreated psychiatric comorbidity, 7. psychotropic or other medications (e.g., beta-blockers) that alter sleep, 8. non-pharmacological tx for sleep or mood outside current trial.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NiteCAPP CARES

Cognitive Behavioral Treatment-Insomnia. Web-based intervention that will include 4 weekly sessions and 4 bimonthly boosters. Each session is to be completed individually by CG (with PWD to extent able) in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed. Session 1 focuses on sleep education, sleep hygiene, and stimulus control. Session 2 focuses on sleep compression, relaxation, and problem solving. Session 3 focuses on coping and stress management and cognitive therapy. Session 4 focuses on a review of skills and plan for maintenance of behavior change.

experimental: NiteCAPP SHARES

Sleep Hygiene and Related Education. Web-based intervention that will include 4 weekly sessions and 4 bimonthly boosters. Each session is to be completed individually by CG (with PWD to extent able) in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed. Session 1 focuses on expanded sleep education and sleep hygiene. Session 2 focuses insomnia education and sleep hygiene support. Session 3 focuses on targeted sleep education and sleep in dementia. Session 4 focuses on a review of skills and plan for maintenance of behavior change. Boosters review skills, encourage practice, and troubleshoot issues.

Interventions

NiteCAPP CARES

Web-based intervention that will include 4 weekly sessions and 4 bimonthly boosters. Each session is to be completed individually by CG (with PWD to extent able) in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed. Session 1 focuses on sleep education, sleep hygiene, and stimulus control. Session 2 focuses on sleep compression, relaxation, and problem solving. Session 3 focuses on coping and stress management and cognitive therapy. Session 4 focuses on a review of skills and plan for maintenance of behavior change.

NiteCAPP SHARES

Web-based intervention that will include 4 weekly sessions and 4 bimonthly boosters. Each session is to be completed individually by CG (with PWD to extent able) in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed. Session 1 focuses on expanded sleep education and sleep hygiene. Session 2 focuses insomnia education and sleep hygiene support. Session 3 focuses on targeted sleep education and sleep in dementia. Session 4 focuses on a review of skills and plan for maintenance of behavior change. Boosters review skills, encourage practice, and troubleshoot issues.

Primary outcome measure

  • Completion [ Time Frame: Single administration at 8 weeks ]
  • Adherence [ Time Frame: Single administration at 8 weeks ]
  • Internet Intervention Utility Questionnaire [ Time Frame: Single administration at 8 weeks ]
  • Satisfaction Survey [ Time Frame: Single administration at 8 weeks ]
  • Insomnia Severity Index [ Time Frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up ]
  • Daily Electronic Sleep Diaries [ Time Frame: Daily at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Pain Intensity - Daily Electronic Sleep Diaries [ Time Frame: Daily at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Pain Unpleasantness - Daily Electronic Sleep Diaries [ Time Frame: Daily at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries [ Time Frame: Daily at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Sleep Onset Latency- Daily Electronic Sleep Diaries [ Time Frame: Daily at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Sleep Efficiency- Daily Electronic Sleep Diaries [ Time Frame: Daily at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Fatigue - Daily Electronic Sleep Diaries [ Time Frame: Daily at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries [ Time Frame: Daily at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Perceived Stress Scale [ Time Frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Kingston Caregiver Stress Scale (KCSS) [ Time Frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Dysfunctional Beliefs About Sleep (DBAS) [ Time Frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Peripheral Arousal [ Time Frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Inflammation [ Time Frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Blood-based Biomarker Interleukin 6 IL-6) [ Time Frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Blood-based Biomarker AβB42 [ Time Frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up ]
  • Change in Blood-based Biomarker Tau [ Time Frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up ]

Central Contacts and Locations

Central contacts

Christina S McCrae

813-974-1804christinamccrae@usf.edu

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Christina McCrae

813-974-1804christinamccrae@usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • Dementia Caregiver

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-04-30.