NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers
Study Details
Study Description
Brief Summary
Compared to their urban counterparts, rural family dementia caregivers (CGs) face increased vulnerability to insomnia and related health concerns (stress, inflammation, depression, anxiety, cognitive disturbance). Cognitive and behavioral treatments for insomnia hold promise for improving insomnia and these related concerns, but is difficult to access in rural areas. Our team developed brief behavioral sleep intervention that improved sleep, arousal, mood, cognition and inflammation (small to large effects). While telehealth improves accessibility, it is still burdensome for CGs due to inflexible scheduling and scarcity of trained therapists. Thus, more research is needed. Web delivery would increase access and web treatments for insomnia are efficacious in non-CG adults, but has not been tested in rural CGs. The proposed trial tests the novel hypothesis that web-based treatment (NiteCAPP) will improve CG health, mood, burden and cognition by targeting their shared underlying mechanisms
- sleep, arousal and inflammation - thereby, returning sympathetic and hypothalamic-pituitary-adrenal axis (HPA) functioning to normal. Demonstration that rural CGs can use NiteCAPP to target sleep, arousal/stress, inflammation and related health concerns has important implications for multiple stakeholders, including rural CGs, rural persons with dementia (PWD), their families, clinicians and policymakers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NiteCAPP CARES Cognitive Behavioral Treatment-Insomnia. 4 online treatment sessions focusing on behavior and cognitions related to sleep. |
Behavioral: NiteCAPP CARES
4 session Web-based Cognitive Behavioral Therapy for Insomnia. Individualized sessions moderated by therapist.
Other Names:
|
| Experimental: NiteCAPP SHARES Sleep Hygiene and Related Education. 4 online treatment sessions focusing on sleep hygiene and related education. |
Behavioral: NiteCAPP SHARES
4 session Web-based Sleep Hygiene and Related Education. Individualized sessions moderated by therapist.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Insomnia Severity Index [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Insomnia severity; score range 0-28 (low severity - high severity)
- Change in Pain Intensity - Daily Electronic Sleep Diaries [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 [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 [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 [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 [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 [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 [Daily at baseline, 8 weeks, 6 month and 12 follow up]
Daily electronic dairies will record daily medication consumption
- Change in Perceived Stress Scale [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Perception of stress; score range: 0-40 (low stress - high stress)
- Change in Kingston Caregiver Stress Scale (KCSS) [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Caregiver stress level; score range: 10-50 (low caregiver stress - high caregiver stress)
- Change in Dysfunctional Beliefs About Sleep (DBAS) [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Sleep-related beliefs; score range: 0-110 (low dysfunctional beliefs - high dysfunctional beliefs)
- Change in Peripheral Arousal [5 mins at rest at baseline, 8 weeks, 6 month and 12 follow up]
Heart Rate Variability (as measured by Holter-Monitoring)
- Change in Blood-based Biomarker High Sensitivity C-Reactive Protein (HS-CRP) [Single blood draw at baseline, 8 weeks, 6 month and 12 follow up]
Inflammation
- 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 AβB42 [Single blood draw at baseline, 8 weeks, 6 month and 12 follow up]
Neurodegenerative
- Change in Blood-based Biomarker Tau [Single blood draw at baseline, 8 weeks, 6 month and 12 follow up]
Neurodegenerative
Secondary Outcome Measures
- Internet Intervention Utility Questionnaire (IIUQ) [Single administration at post-treatment - 8 weeks]
Modified for NiteCAPP; score range: 0-65 (least satisfied - most satisfied)
- Change in State-Trait Anxiety Inventory (STAI) [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Trait and state anxiety; score range: 20-80 (low anxiety - high anxiety)
- Change in Depression (Beck Depression Inventory-II) [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Depression severity; score range: 0-63 (normal - extreme depression)
- Change in 36-Item Short Form Survey (SF-36) [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Self-reported health; score range: low quality of life to high quality of life
- Change in Caregiver Burden (Zarit Burden Scale) [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Caregiver burden; score range: 0-48 (low burden - high burden)
- Change in Cognitive Failures Questionnaire (CFQ) [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Frequency of lapses of attention, memory, and cognition in everyday life; score range: 0-100 (low frequency of mistakes - high frequency of mistakes)
- Change in Dementia Patient's Caregiver Quality of Life Scale [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Quality of life related to psychological well-being
- Change in Objective Wake After Sleep Onset (Actigraph) [Daily at baseline, 8 weeks, 6 month and 12 follow up]
Wake after sleep onset via Actiwatch-2
- Change in Objective Sleep Onset Latency (Actigraph) [Daily at baseline, 8 weeks, 6 month and 12 follow up]
Sleep Onset Latency via Actiwatch-2
- Change in Objective Sleep Efficiently (Actigraph) [Daily at baseline, 8 weeks, 6 month and 12 follow up]
Sleep Efficiency via Actiwatch-2
- Change in NIH Toolbox [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
20 minute computerized cognitive tasks
- Change in Daily Joggle Battery [Daily at baseline, 8 weeks, 6 month and 12 follow up]
15 minute computerized cognitive tasks
Other Outcome Measures
- Change in Neuropsychiatric Inventory(NPI) Nighttime Behavior Scale [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Frequency and severity of the nighttime behavior disturbance; score range: 2-12 (low disturbance - high disturbance)
- Change in Dementia Severity Rating Scale [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Dementia severity: score range: 0-54 (mild - moderate)
- Change in Patient-Caregiver Functional Unit Scale (PCFUS) [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Stability of the patient-caregiver dyad
- Change in Godin Leisure-Time Exercise Questionnaire [Single administration at baseline, 8 weeks, 6 month and 12 follow up]
Leisure-time physical activities
- Satisfaction Survey [Single administration at post-treatment - 8 weeks]
Experience with the assessments, procedures, and other features of the research study; score range: 9-90 (low satisfaction - high satisfaction)
Eligibility Criteria
Criteria
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,
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Missouri | Columbia | Missouri | United States | 65212 |
Sponsors and Collaborators
- University of Missouri-Columbia
Investigators
- Principal Investigator: Christina S McCrae, University of Missouri-Columbia
Study Documents (Full-Text)
None provided.More Information
Publications
- Curtis AF, Williams JM, McCoy KJM, McCrae CS. Chronic Pain, Sleep, and Cognition in Older Adults With Insomnia: A Daily Multilevel Analysis. J Clin Sleep Med. 2018 Oct 15;14(10):1765-1772. doi: 10.5664/jcsm.7392.
- Heinzelmann M, Lee H, Rak H, Livingston W, Barr T, Baxter T, Scattergood-Keepper L, Mysliwiec V, Gill J. Sleep restoration is associated with reduced plasma C-reactive protein and depression symptoms in military personnel with sleep disturbance after deployment. Sleep Med. 2014 Dec;15(12):1565-70. doi: 10.1016/j.sleep.2014.08.004. Epub 2014 Sep 10.
- Joling KJ, van Hout HP, Schellevis FG, van der Horst HE, Scheltens P, Knol DL, van Marwijk HW. Incidence of depression and anxiety in the spouses of patients with dementia: a naturalistic cohort study of recorded morbidity with a 6-year follow-up. Am J Geriatr Psychiatry. 2010 Feb;18(2):146-53. doi: 10.1097/JGP.0b013e3181bf9f0f.
- Livingston WS, Rusch HL, Nersesian PV, Baxter T, Mysliwiec V, Gill JM. Improved Sleep in Military Personnel is Associated with Changes in the Expression of Inflammatory Genes and Improvement in Depression Symptoms. Front Psychiatry. 2015 Apr 30;6:59. doi: 10.3389/fpsyt.2015.00059. eCollection 2015.
- Markowitz JS, Gutterman EM, Sadik K, Papadopoulos G. Health-related quality of life for caregivers of patients with Alzheimer disease. Alzheimer Dis Assoc Disord. 2003 Oct-Dec;17(4):209-14.
- McCrae CS, Dzierzewski JM, McNamara JP, Vatthauer KE, Roth AJ, Rowe MA. Changes in Sleep Predict Changes in Affect in Older Caregivers of Individuals with Alzheimer's Dementia: A Multilevel Model Approach. J Gerontol B Psychol Sci Soc Sci. 2016 May;71(3):458-62. doi: 10.1093/geronb/gbu162. Epub 2014 Nov 26.
- McCrae CS, Vatthauer KE, Dzierzewski JM, Marsiske M. Habitual Sleep, Reasoning, and Processing Speed in Older Adults with Sleep Complaints. Cognit Ther Res. 2012 Apr;36(2):156-164.
- Ory MG, Hoffman RR 3rd, Yee JL, Tennstedt S, Schulz R. Prevalence and impact of caregiving: a detailed comparison between dementia and nondementia caregivers. Gerontologist. 1999 Apr;39(2):177-85.
- Rowe MA, McCrae CS, Campbell JM, Benito AP, Cheng J. Sleep pattern differences between older adult dementia caregivers and older adult noncaregivers using objective and subjective measures. J Clin Sleep Med. 2008 Aug 15;4(4):362-9.
- Vitaliano PP, Murphy M, Young HM, Echeverria D, Borson S. Does caring for a spouse with dementia promote cognitive decline? A hypothesis and proposed mechanisms. J Am Geriatr Soc. 2011 May;59(5):900-8. doi: 10.1111/j.1532-5415.2011.03368.x. Review.
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