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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of South Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • NiteCAPP CARES

    Behavioral

    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

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: NiteCAPP CARESExperimental treatment 1 intervention
Group B: NiteCAPP SHARESExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Completion

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

Time frame
Single administration at 8 weeks
2

Adherence

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

Time frame
Single administration at 8 weeks
3

Internet Intervention Utility Questionnaire

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

Time frame
Single administration at 8 weeks
4

Satisfaction Survey

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

Time frame
Single administration at 8 weeks

Secondary outcomes

1

Change in State-Trait Anxiety Inventory (STAI)

Inventory that asks respondents to rate how true 20 self-descriptive statements (e.g., I feel calm) are on a 4-point scale (1 = not at all, 4 = very much so). Typically, respondents are asked to rate statements according to how they generally feel (trait-anxiety scale) and how they feel in the current moment (state-anxiety scale). Total scores range from 20 to 80, with higher scores indicating greater maladjustment.

Time frame
Single administration at baseline, 8 weeks, 6 month and 12 follow up
2

Change in Depression (Beck Depression Inventory-II)

BDI contains 21 items that measure severity of depressive symptomatology on a three-point scale (0 = absence of symptoms, 3 = most severe). Respondents answer for the previous week. Total scores range from 0 to 63. Ranges for clinical levels of depression are 0 to 13 (minimal), 14 to 19 (mild), 20 to 28 (moderate), and 29 to 63 (severe).

Time frame
Single administration at baseline, 8 weeks, 6 month and 12 follow up
3

Change in 36-Item Short Form Survey (SF-36)

The SF-36 is a 36-item scale that assesses health status and quality of life The SF-36 includes eight domains: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems); bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. Participants respond based on how they have felt over the previous week. The items use Likert-type scales, some with 5 or 6 points and others with 2 or 3 points. The SF-36 is a sensitive indicator of CG mental and physical health.

Time frame
Single administration at baseline, 8 weeks, 6 month and 12 follow up
4

Change in Caregiver Burden (Zarit Burden Scale)

Self-report measure of caregiver burden. 12-item scale that asks caregivers to rate from never (0) to nearly always (4) how often they experience feelings of stress or burden across various aspects and situations of caregiving.

Time frame
Single administration at baseline, 8 weeks, 6 month and 12 follow up

Other outcomes

1

Change in Neuropsychiatric Inventory(NPI) Nighttime Behavior Scale

CG indicates the frequency and severity of 8 nighttime behaviors of the PWD (difficulty falling asleep, wandering during the night, etc.), as well as the level of emotional distress they experience associated with each behavior.

Time frame
Single administration at baseline, 8 weeks, 6 month and 12 follow up
2

Change in Dementia Severity Rating Scale

CG rates severity of dementia across several domains: memory, speech and language, recognition of family members, orientation to place and time, ability to make decisions, social and community activity, home activities and responsibilities, personal care, eating, control or urination and bowels, ability to get from place to place. Higher scores indicate more severe dementia.

Time frame
Single administration at baseline, 8 weeks, 6 month and 12 follow up
3

Change in Patient-Caregiver Functional Unit Scale (PCFUS)

Questionnaire that assesses the stability of the CG/PWD dyad for 14 activities of daily living and instrumental activities of daily living. CG respondents indicate the patient's functional ability, whether the CG assists with the task, and whether the CG has emotional or physical difficulty assisting with the task

Time frame
Single administration at baseline, 8 weeks, 6 month and 12 follow up
4

Change in Godin Leisure-Time Exercise Questionnaire

This 4-item self-administered questionnaire assesses the number of times one engages in mild, moderate and strenuous LTPA bouts of at least 15 min duration in a typical week.

Time frame
Single administration at baseline, 8 weeks, 6 month and 12 follow up

Sponsors and contacts

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