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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23AG070378-03 | U.S. NIH Grant/Contract | View source | |
| 2025P009764 | Other Identifier | Emory Insight Humans IRB |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together.
Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to the earlier placement of the PLwD in nursing homes and increases the risk for many psychological and cognitive health issues and poor quality of life for both the PLwD and the caregivers. Given the potential harmful side effects of medications, non-medication alternatives, such as Cognitive Behavioral Therapy for Insomnia (CBTi), may be safer to improve disturbed sleep in this population. CBTi which includes stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has durable and sustained effects on sleep outcomes over the long term. CBTi has improved sleep disturbances in PLwD and their caregivers, separately. Since disturbed sleep in the PLwD-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for intervention has the potential to lead to improved sleep and health outcomes for both persons.
There is no current published research on CBTi when the PLwD and their caregivers receive the intervention at the same time; as a result, the research team aims to examine the 1) feasibility and 2) preliminary efficacy of 6-week CBTi intervention for community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances. PLwD-caregiver dyads will participate in videoconferencing sessions. In addition, semi-structured interviews will take place to examine the acceptability and satisfaction with the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBTi) | Experimental | Participant dyads will receive CBTi via videoconferencing sessions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | The intervention protocol will include CBTi principles like stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring. It will be done over 6 weeks with one session weekly via videoconference. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insomnia | Insomnia will be measured using the Insomnia Severity Index. The insomnia severity index ahs seven questions. The seven answers are added up to get a total score. Total score categories: 0-7= No clinically significant insomnia 8-14= Subthreshold insomnia 15-21= Clinical insomnia (moderate severity) 22-28= Clinical insomnia (Severe) | Baseline, 1-week post-intervention, and 3 months post-intervention |
| Change in Sleep Efficiency | Sleep Efficiency will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns. | Baseline, 1-week post-intervention, and 3 months post-intervention |
| Change in in Sleep Onset Latency | Sleep onset latency will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns. | Baseline, 1-week post-intervention, and 3 months post-intervention |
| Change in Wake After Sleep Onset | Wake after sleep onset will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns. | Baseline, 1-week post-intervention, and 3 months post-intervention |
| Adherence with Study Interventions (feasibility) | Feasibility of the interventions will be assessed with rates of adherence to the study components throughout the study participation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression | Depression will be measured using the Center for Epidemiologic Studies Depression scale. The Center for Epidemiologic Studies Depression scale has 20 questions. The 20 answers are added up to get a total score between 0 and 60. Total score categories: 16 or greater = Clinically significant depressive symptoms | Baseline, 1-week post-intervention, and 3 months post-intervention |
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Inclusion Criteria for the PLwCI:
Inclusion Criteria for Caregivers:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Glenna S Brewster, PhD, RN, FNP | Contact | (404) 712-9164 | glenna.brewster@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Glenna Brewster, PhD, RN, FNP | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Healthcare System | Recruiting | Atlanta | Georgia | 30322 | United States |
The research team will share the participants' research identification with instrument responses.
Starting 01/01/2028
Requests can be sent to the PI with a document that includes the background and research questions to conduct secondary data analyses.
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| weekly during the intervention period up to 3 months post-intervention |
| Satisfaction with intervention components | Satisfaction with the intervention components will be assessed with the study satisfaction measure questionnaire that has 16 questions type that uses an agree, disagree scale as a range of answer options that go from strongly agree to strongly disagree. | 1 week post-intervention |
| Change in the Quality of Life | Quality of Life will be measured using the research and development (RAND) Medical Outcomes short form (SF)-36. The insomnia severity index has 36 questions which have subscales that total 100. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Baseline, 1-week post-intervention, and 3 months post-intervention |
| D002493 |
| Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |