Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners
- Conditions
- DementiaSleep Disturbance
- Interventions
- Behavioral: Cognitive Behavioral Therapy for Insomnia
- Registration Number
- NCT06250725
- Lead Sponsor
- Emory University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
- PLwCI: Moderate to severe cognitive impairment
- Individuals who are not yet adults
- Pregnant women
- Prisoners
- Individuals who are not able to clearly understand English.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cognitive Behavioral Therapy for Insomnia (CBTi) Cognitive Behavioral Therapy for Insomnia Participant dyads will receive CBTi via videoconferencing sessions
- Primary Outcome Measures
Name Time Method Adherence with Study Interventions (feasibility) weekly during the intervention period up to 3 months post-intervention Feasibility of the interventions will be assessed with rates of adherence to the study components throughout the study participation.
Change in insomnia Baseline, 1-week post-intervention, and 3 months post-intervention 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)Change in Sleep Efficiency Baseline, 1-week post-intervention, and 3 months post-intervention 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.
Satisfaction with intervention components 1 week post-intervention 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.
Change in in Sleep Onset Latency Baseline, 1-week post-intervention, and 3 months post-intervention 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.
Change in Wake After Sleep Onset Baseline, 1-week post-intervention, and 3 months post-intervention 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.
- Secondary Outcome Measures
Name Time Method Change in depression Baseline, 1-week post-intervention, and 3 months post-intervention 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 symptomsChange in the Quality of Life Baseline, 1-week post-intervention, and 3 months post-intervention 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.
Trial Locations
- Locations (1)
Emory Healthcare System
🇺🇸Atlanta, Georgia, United States