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NCT04426838

Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad

Completed NA Last updated 20 March 2023
What this trial tests

NA trial testing Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference in Cognitive Impairment in 44 participants. Completed in 10 March 2023.

Timeline
30 September 2020
Primary endpoint
10 March 2023
10 March 2023

Quick facts

Lead sponsorEmory University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment44
Start date30 September 2020
Primary completion10 March 2023
Estimated completion10 March 2023
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Emory University

Who can join

18 and older, any sex, with Cognitive Impairment or Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Psychological treatments for depression and anxiety in dementia and mild cognitive impairment.
    Orgeta V, Leung P, Del-Pino-Casado R, Qazi A, et al · · 2022 · cited 47× · PMID 35466396 · DOI 10.1002/14651858.cd009125.pub3

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Other recruiting trials for Cognitive Impairment

Currently open trials in the same condition.

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Data sources for this page

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