Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad

NCT04426838 | Completed

• 1 other identifier: IRB00115210
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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 receive CBTi via 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.

Conditions

Cognitive Impairment; Dementia

Keywords

Cognitive behavioral therapy for insomnia; Insomnia; Caregiver; Cognitive impairment

Outcome Measures

Primary Outcomes (3)

• Change in Adherence with Study Interventions

  Feasibility of the interventions will be assessed with rates of adherence to the study components weekly and over the 4 weeks

  Weeks 1, 2, 3, 4

• Percent Attrition from the Study

  Feasibility of the interventions will be assessed with the percent of participants leaving the study over the 4 week intervention.

  Week 4

• Acceptability the Intervention

  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.

  Week 5 (1 week post-intervention)

Secondary Outcomes (12)

• Change in Sleep Disorders Inventory (SDI) - Frequency Score

  Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)

• Change in Sleep Disorders Inventory (SDI) - Severity Score

  Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)

• Change in Sleep Disorders Inventory (SDI) - Caregiver Distress Score

  Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)

• Change in Insomnia Severity Index Score

  Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)

• Change in 12-Item Short Form-12 (SF-12v2) Health Survey Score

  Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)

Study Arms (2)

PLwD Cognitive Behavioral Therapy for Insomnia (CBTi)

EXPERIMENTAL

Persons living with dementia in a dyad receiving the CBTi intervention in a videoconferencing format.

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference

Caregiver Cognitive Behavioral Therapy for Insomnia (CBTi)

EXPERIMENTAL

Caregivers in a dyad receiving the CBTi intervention in a videoconferencing format.

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference

Interventions

Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference BEHAVIORAL

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.

Caregiver Cognitive Behavioral Therapy for Insomnia (CBTi); PLwD Cognitive Behavioral Therapy for Insomnia (CBTi)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregiver-reported diagnosis of cognitive impairment and Alzheimer's disease and related dementias (ADRD)
• Co-residence with the caregiver in the community
• Montreal Cognitive Assessment (MOCA) score between 12 and 25
• Stable dose of psychotropic medications, anti-dementia, sedatives/hypnotics, or opioids in the past 90 days
• Presence of sleep problems determined by using the proxy-rated Sleep Disorders Inventory (presence of at least one sleep disturbance symptom of moderate severity)
• Informal caregivers (family/friends) of co-residing PLwD
• Providing unpaid assistance, on average 20 hours weekly, for a person in the early stage of illness who is community-dwelling
• Presence of sleep problems: sleep onset latency or wake after sleep onset more than 30 minutes more than 3 nights weekly
• Tolerate and agrees to wear wrist actigraph
• Be able to read, speak and understand English
• Have no uncorrectable vision or hearing deficits that might impede participation

You may not qualify if:

• None
• 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

Sponsors & Collaborators

• Emory University: lead
• Alzheimer's Association: collaborator

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Goizueta Alzheimer's Disease Research Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Glenna Brewster, PhD, RN

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 40 dyads of people living with dementia (PLwD) and their caregivers will be enrolled to participate in the behavioral intervention together.

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: September 30, 2020
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)