Web-based Interventions for Insomnia in Rural Dementia Caregivers

This study is testing two web-based programs, NiteCAPP CARES and NiteCAPP SHARES, to see if they can help rural dementia caregivers (CGs) with insomnia. These programs are designed to be completed online in short weekly sessions. The study aims to enroll 100 caregiver and person with dementia (PWD) pairs. To join, you must be 18 or older, live with a person with dementia, be willing to be randomly assigned to a program, read English, and have been diagnosed with insomnia for at least six months. The researchers will measure how many people complete the programs, how well they stick to the programs, and how useful they find the online tools after 8 weeks.

Study design
This interventional study plans to enroll 100 participants. Participants will be randomly assigned to one of two web-based intervention groups.
What's involved
Participants will complete 4 weekly online sessions and 4 bimonthly booster sessions. Each session should take less than 45 minutes to complete individually.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the short-term effects of the intervention after 8 weeks, and also long-term effects at 6 and 12 months.

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NCT04896775

NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers

Recruiting
NAAges 18+InterventionalTreatment
University of South Florida
~100 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:NiteCAPP CARESNiteCAPP SHARES

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Completion
Measured over Single administration at 8 weeks
+20 more outcomes measured
Insomnia
Dementia
1 sites across 1 states
Florida1
  • Christina S McCrae · PRINCIPAL_INVESTIGATOR · University of South Florida

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Eligibility criteria

Inclusion

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.
  • CompletionSingle administration at 8 weeks

    Percentage of sessions completed out of the 4 sessions/modules included in NiteCAPP and WebSHE.

  • AdherenceSingle administration at 8 weeks

    Percentage of the intervention instructions followed as indicated on the treatment adherence logs completed each day during treatment.

  • Internet Intervention Utility QuestionnaireSingle administration at 8 weeks

    Questionnaire with 15 items, including two open-ended questions, that assesses the usability, like-ability, and usefulness of online interventions using a 5-point Likert scale from 1-not at all to 5-very. The two open-ended questions ask the participant to list the most and least helpful parts of the program

  • Satisfaction SurveySingle administration at 8 weeks

    Survey that assesses the patient's experience and satisfaction with treatment.

  • Insomnia Severity IndexSingle administration at baseline, 8 weeks, 6 month and 12 follow up

    Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used as an outcome assessment in insomnia treatment research.

  • Daily Electronic Sleep DiariesDaily at baseline, 8 weeks, 6 month and 12 follow up

    Completed each morning (\~5 mins) during each assessment period. Electronic daily diaries collecting self-reported information on caregiver sleep onset latency (time to fall asleep), wake after sleep onset (time awake after sleep onset to last awakening), and sleep efficiency (total sleep time divided by time in bed and multiplied by 100). We developed and tested these electronic diaries.

  • Change in Pain Intensity - Daily Electronic Sleep DiariesDaily at baseline, 8 weeks, 6 month and 12 follow up

    Daily electronic dairies will record pain intensity; range: 0-100 (no pain- most intense)

  • Change in Pain Unpleasantness - Daily Electronic Sleep DiariesDaily at baseline, 8 weeks, 6 month and 12 follow up

    Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)

  • Change in Wake After Sleep Onset - Daily Electronic Sleep DiariesDaily at baseline, 8 weeks, 6 month and 12 follow up

    Daily electronic dairies will record wake after sleep onset (number of minutes)

  • Change in Sleep Onset Latency- Daily Electronic Sleep DiariesDaily at baseline, 8 weeks, 6 month and 12 follow up

    Daily electronic dairies will record sleep onset latency (number of minutes)

  • Change in Sleep Efficiency- Daily Electronic Sleep DiariesDaily at baseline, 8 weeks, 6 month and 12 follow up

    Daily electronic dairies will record sleep efficiency

  • Change in Fatigue - Daily Electronic Sleep DiariesDaily at baseline, 8 weeks, 6 month and 12 follow up

    Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)

  • Change in Sleep and Pain Medication - Daily Electronic Sleep DiariesDaily at baseline, 8 weeks, 6 month and 12 follow up

    Daily electronic dairies will record daily medication consumption

  • Change in Perceived Stress ScaleSingle administration at baseline, 8 weeks, 6 month and 12 follow up

    Perceived Stress Scale is a self-report measure of how life situations are perceived as stressful. The scale consists of 15 items corresponding to everyday situation and participants are asked to rate on a Likert scale from 0 (never) to 4 (very often) how

  • Change in Kingston Caregiver Stress Scale (KCSS)Single administration at baseline, 8 weeks, 6 month and 12 follow up

    A 10-item scale that asks caregivers to rate on a scale from 1 (no stress) to 5 (extreme stress) how much stress they experience related to various aspects of caregiving.

  • Change in Dysfunctional Beliefs About Sleep (DBAS)Single administration at baseline, 8 weeks, 6 month and 12 follow up

    A self-report measure of sleep-related arousal. This measure consists of 30 questions intended to measure 5 dimensions: misconceptions about the causes of insomnia, misattributions or amplifications of the consequences, unrealistic expectations, control, and predictability of sleep and faulty beliefs about sleep promoting practices. Although the original scale used a 100 mm VAS, subsequent research with the DBAS has used an 11-point Likert scale (0 = strongly disagree, 10 = strongly agree), and the latter response method will be used.

  • Change in Peripheral ArousalSingle administration at baseline, 8 weeks, 6 month and 12 follow up

    Holter monitor assessed 5 min ECG recordings at rest at home (enhancing ecological validity). Variables: RMSDNN (root mean sqrd standard dev. of N-N intervals), pNN50 (percent of N-N intervals less than 50 ms), LF over HF (high frequency divided by low frequency ratio; index of autonomic nervous system regulation).

  • Change in InflammationSingle blood draw at baseline, 8 weeks, 6 month and 12 follow up

    Blood based biomarkers will be examined at each assessment period. Biomarkers include: inflammatory (HS-CRP, IL-6), neurodegenerative ( AβB42, tau levels)

  • Change in Blood-based Biomarker Interleukin 6 IL-6)Single blood draw at baseline, 8 weeks, 6 month and 12 follow up

    Inflammation

  • Change in Blood-based Biomarker AβB42Single blood draw at baseline, 8 weeks, 6 month and 12 follow up

    Neurodegenerative

  • Change in Blood-based Biomarker TauSingle blood draw at baseline, 8 weeks, 6 month and 12 follow up

    Neurodegenerative