Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad

• ClinicalTrials.gov Identifier: NCT04426838
• Recruitment Status: Recruiting
• First Posted: June 11, 2020
• Last Update Posted: October 19, 2020
• Sponsor: Emory University
• Collaborator: Alzheimer's Association
• Information provided by (Responsible Party): Glenna Brewster, Emory University

Tracking Information

• First Submitted Date: June 9, 2020
• First Posted Date: June 11, 2020
• Last Update Posted Date: October 19, 2020
• Actual Study Start Date: September 30, 2020
• Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 9, 2020)

• Change in Adherence with Study Interventions [ Time Frame: Weeks 1, 2, 3, 4 ]
  Feasibility of the interventions will be assessed with rates of adherence to the study components weekly and over the 4 weeks
• Percent Attrition from the Study [ Time Frame: Week 4 ]
  Feasibility of the interventions will be assessed with the percent of participants leaving the study over the 4 week intervention.
• Acceptability the Intervention [ Time Frame: Week 5 ]
  Acceptability of the interventions will be assessed with a qualitative interview with caregivers after completing the intervention. There is not a summary score for the open-ended questions asked during the interview.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 9, 2020)

• Change in Sleep Disorders Inventory (SDI) - Frequency Score [ Time Frame: Baseline, Week 5, Month 4 ]
  The SDI asks caretakers to report the frequency that eight symptoms of insomnia have been exhibited by the PLWD in the past two weeks. Responses range from 0 to 4 where 0 = not present and 4 = every night. Total frequency scores range from 0 to 32 with higher scores indicating more frequent symptoms of insomnia.
• Change in Sleep Disorders Inventory (SDI) - Severity Score [ Time Frame: Baseline, Week 5, Month 4 ]
  The SDI asks caretakers to report the severity of eight symptoms of insomnia being exhibited by the PLWD in the past two weeks. Responses range from 0 to 3 where 0 = not present and 3 = marked. Total frequency scores range from 0 to 24 with higher scores indicating more severe symptoms of insomnia.
• Change in Sleep Disorders Inventory (SDI) - Caregiver Distress Score [ Time Frame: Baseline, Week 5, Month 4 ]
  The SDI asks caretakers to report the amount of distress they are experiencing due to eight symptoms of insomnia being exhibited by the PLWD in the past two weeks. Responses range from 0 to 5 where 0 = not at all and 5 = extremely. Total frequency scores range from 0 to 40 with higher scores indicating more severe caregiver distress.
• Change in Insomnia Severity Index Score [ Time Frame: Baseline, Week 5, Month 4 ]
  The Insomnia Severity Index includes 7 questions asking about insomnia during the past two weeks. Responses are given on a scale from 0 to 4 where 0 = no problems and 4 = the most extreme problems. Total scores range from 0 to 28 where higher scores indicate greater problems with insomnia.
• Change in 12-Item Short Form-12 (SF-12v2) Health Survey Score [ Time Frame: Baseline, Week 5, Month 4 ]
  The SF-12 Health Survey includes 12 items asking respondents how they have been feeling and activities they are doing. Physical and mental health composite scores are computed and range from 0 to 100 where 100 is the highest level of health. The computed composite scores can be compared with a national norm with a mean of 50 and a standard deviation of 10.
• Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score [ Time Frame: Baseline, Week 5, Month 4 ]
  The CES-D includes 20 items asking respondents how frequently they felt symptoms of depression during the past week. Responses are given on a scale from 0 to 3 where 0 = rarely or none of the time and 3 = most or all of the time. Certain items are reverse scored so that lower scores equate to lower symptom frequency. Total scores range from 0 to 60 with higher scores indicating greater symptoms of depression.
• Change in Sleep Duration [ Time Frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4 ]
  Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Sleep duration (minutes per night) will be assessed with actigraphy.
• Change in Sleep Fragmentation Index [ Time Frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4 ]
  Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. The sleep fragmentation index (number of awakenings and sleep stage shifts divided by sleep time) will be assessed with actigraphy.
• Change in Sleep Onset Latency [ Time Frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4 ]
  Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Sleep onset latency (the length of time, in minutes, that it takes to transition from wakefulness to sleep) will be assessed with actigraphy.
• Change in Wake After Sleep Onset [ Time Frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4 ]
  Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Wake after sleep onset (periods of wakefulness occurring after sleep onset) will be assessed with actigraphy.
• Change in Bed Time [ Time Frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4 ]
  Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Bed time will be assessed with actigraphy.
• Change in Wake Time [ Time Frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4 ]
  Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Wake time will be assessed with actigraphy.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
• Official Title: Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
• Brief Summary: Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to earlier placement of the PLwD in nursing homes and increase 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 researchers will examine the 1) feasibility; 2) acceptability; and 3) preliminary efficacy of 4-week CBTi intervention for community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances. Forty PLwD-caregiver dyads will be randomized to face-to face or videoconferencing sessions. Preliminary efficacy of the intervention will be assessed using objective (actigraphy) and subjective sleep quality measures. In addition, semi-structured interviews will be conducted to examine the acceptability and satisfaction with the intervention.

Detailed Description

Up to 71% of the persons living with dementia (PLwD) and 70% of their caregivers experience sleep disturbances, which are distressing for both the PLwD and their caregivers. Specifically, PLwD often experience restlessness and fragmented sleep, which in turn can affect caregivers' sleep patterns leading to multiple nightly awakenings, shorter sleep duration, and/or inconsistent sleep-wake times. These disturbances increase the risk for a myriad of psychological, cognitive, behavioral, and physiological health issues and poor quality of life for the dyad. Given the interdependence of the dyadic sleep disturbances and the negative health consequences of sleep disturbances on the dyad, there is a critical need to develop and provide effective interventions to improve their sleep. Pharmacologic treatment often results in potential harmful side effects like falls and cognitive decline; therefore, non-pharmacologic approaches are recommended for this population.

Cognitive behavioral therapy for insomnia (CBTi), a non-pharmacologic intervention that has demonstrated effectiveness for improving sleep disturbances in multiple populations, is delivered in various formats including face-to-face and videoconferencing. Individually, PLwD and caregivers have successfully deployed behavioral sleep techniques, resulting in improved sleep quality. However, there is no current published research on CBTi completed simultaneously by the PLwD-caregiver dyad, and that is exactly what we seek to do with early-stage individuals and their caregivers. We premise this effort on the notion that a dyadic intervention can use early-stage individuals' retained capacity for communication and comprehension to establish in-the-moment agreements about strategies the caregiver can employ to enact and facilitate positive sleep behaviors in the PLwD and to pair that with acquired strategies to engender his/her own positive sleep behaviors.

This project seeks to gather formative and preliminary data on CBTi delivered simultaneously to the PLwD-caregiver dyad. The researchers will use a quantitative, descriptive approach to determine the feasibility, acceptability, and preliminary efficacy of a 4-session CBTi intervention administered to 40 PLwD-caregiver dyads randomized to face-to face or videoconferencing sessions who will receive the intervention as a unit. Participants will be recruited through the Alzheimer's Association and the Goizueta Alzheimer's Disease Research Center at Emory University. Objective and subjective sleep, depressive symptoms, and cognitive health data will be collected at baseline, and 1 week and 3 months post-completion of the intervention.

In community-dwelling PLwD and their caregivers where both persons in the dyad self-report sleep disturbances, the specific aims for this study are:

1. Assess the feasibility of a face-to-face or video conferencing dyad-based CBTi intervention.
2. Evaluate the acceptability of a face-to-face or video conferencing dyad-based CBTi intervention.
3. Examine the preliminary efficacy of face-to-face or video conferencing CBTi intervention on sleep quality outcomes including sleep efficiency and perceived sleep quality.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Dementia

Intervention

• Behavioral: Face-to-Face CBTi
  The CBTi protocol will include stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring which will be done over 4 weeks with one session weekly delivered face-to-face in the home of the dyad.
• Behavioral: Videoconferencing CBTi
  The CBTi protocol will include stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring which will be done over 4 weeks with one session weekly delivered via videoconference.

Study Arms

• Experimental: PLwD Face-to-Face Intervention
  Persons living with dementia in a dyad randomized to receive the CBTi intervention in a face-to-face format.
  Intervention: Behavioral: Face-to-Face CBTi
• Experimental: Caregiver Face-to-Face Intervention
  Caregivers in a dyad randomized to receive the CBTi intervention in a face-to-face format.
  Intervention: Behavioral: Face-to-Face CBTi
• Experimental: PLwD Videoconferencing Intervention
  Persons living with dementia in a dyad randomized to receive the CBTi intervention in a videoconferencing format.
  Intervention: Behavioral: Videoconferencing CBTi
• Experimental: Caregiver Videoconferencing Intervention
  Caregivers in a dyad randomized to receive the CBTi intervention in a videoconferencing format.
  Intervention: Behavioral: Videoconferencing CBTi

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 9, 2020): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2022
• Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria for the PLWD

• Physician diagnosis of mild Alzheimer's disease and related dementias (ADRD) using standard assessments and diagnostic criteria or Clinical Dementia Rating (CDR) of 1
• Community-dwelling with no plan of moving into an assisted living or nursing home community in the next six months
• Stable dose of psychotropic medications, anti-dementia, sedatives/hypnotics, or opioids in the past 90 days

Inclusion Criteria for the Caregiver

• Informal caregivers (family/friends) of PLWD
• Providing at least 4 hours per day unpaid assistance, on average, for a person in the early stage of illness who is community-dwelling and for whom there is no established plan for moving into an assisted living or nursing home community in the next six months

Inclusion Criteria for the Dyad

• Tolerate and agrees to wear wrist actigraph
• Presence of sleep problems determined first using the Neuropsychiatric Inventory sleep disorders item then the proxy-rated Sleep Disorders Inventory (presence of at least one sleep disturbance symptom of moderate severity
• Be able to read, speak and understand English
• Have no uncorrectable vision or hearing deficits that might impede participation

Exclusion Criteria for the PLWD

• Planned transition to another residential or institutional care setting in less than 6 months

Exclusion Criteria for the Caregivers

• Moderate to severe cognitive impairment defined as MoCA score <17
• Current sedative-hypnotic or other sleep aid use on a regular or as needed schedule within the prior three months
• Presence of an acute medical or psychiatric condition which would interfere with the subject's ability to realistically follow the study protocol

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Glenna Brewster, PhD, RN; 404-712-9164; glenna.brewster@emory.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04426838
• Other Study ID Numbers: IRB00115210
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Glenna Brewster, Emory University
• Study Sponsor: Emory University
• Collaborators: Alzheimer's Association

Investigators

• Principal Investigator: Glenna Brewster, PhD, RN; Emory University

• PRS Account: Emory University
• Verification Date: October 2020