NCT04896775 · University of South Florida
NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers
(NiteCAPP)
What this study is about
The goal of this project evaluate the effectiveness 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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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 measures
Completion
Time frame: Single administration at 8 weeks
Percentage of sessions completed out of the 4 sessions/modules included in NiteCAPP and WebSHE.
Adherence
Time frame: Single 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 Questionnaire
Time frame: Single 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 Survey
Time frame: Single administration at 8 weeks
Survey that assesses the patient's experience and satisfaction with treatment.
Insomnia Severity Index
Time frame: Single 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 Diaries
Time frame: Daily 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 Diaries
Time frame: Daily 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 Diaries
Time frame: Daily 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 Diaries
Time frame: Daily 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 Diaries
Time frame: Daily 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 Diaries
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Daily electronic dairies will record sleep efficiency
Change in Fatigue - Daily Electronic Sleep Diaries
Time frame: Daily 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 Diaries
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Daily electronic dairies will record daily medication consumption
Change in Perceived Stress Scale
Time frame: Single 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)
Time frame: 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)
Time frame: 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 Arousal
Time frame: Single 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 Inflammation
Time frame: Single 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)
Time frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Inflammation
Change in Blood-based Biomarker AβB42
Time frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Neurodegenerative
Change in Blood-based Biomarker Tau
Time frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Neurodegenerative
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Tampa, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 30, 2026 · Source of record for eligibility and locations