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Improving Sleep in Veterans and Their CGs (SLEEP-E Dyads)

This study has been completed.
Emory University
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: January 24, 2014
Last updated: August 24, 2016
Last verified: August 2016
This study addresses the neglected topic of sleep disturbance in older caregiving dyads-a topic that has important implications for the safety, health, functioning and quality of life of older Veterans living at home and being cared for by a family caregiver (CG). The purpose of the first phase of this study is determine the relationship between CG and care recipient (CR) sleep and describe the impact of dyadic sleep to daytime functioning and well-being for Veterans and their caregivers. The information from phase 1 will inform the next study phase in which the investigators develop and field test non-pharmacological, technology based, sleep hygiene, exercise and meditation interventions to improve sleep in Veteran caregiving dyads.

Condition Intervention Phase
Sleep Quality
Behavioral: SLEEP-E Dyads Sleep Hygiene and Cognitively Based Compassion Training
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Sleep In Veterans and Their Family Caregivers

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Sleep Efficiency [ Time Frame: Week 6 of 6 Week Intervention ] [ Designated as safety issue: No ]
    Objective measure of sleep efficiency obtained from the wrist actigraphs

Secondary Outcome Measures:
  • Subjective Sleep [ Time Frame: Week 6 of 6 Week Intervention ] [ Designated as safety issue: No ]
    Subjective sleep quality from daily journals

  • Daytime Mood [ Time Frame: Week 6 of 6 week intervention ] [ Designated as safety issue: No ]
    daily measures of mood from journal

  • Sleep Hygiene Behaviors [ Time Frame: Weeks 5 and 6 of 6 Week Intervention ] [ Designated as safety issue: No ]
    Daily sleep hygiene behaviors from e- journals composite of sleep hygiene indicators

Other Outcome Measures:
  • Intervention Adherence [ Time Frame: Daily for 6 Weeks ] [ Designated as safety issue: No ]
    Participation in daily sessions; daily journals - modules viewed

Enrollment: 323
Study Start Date: November 2010
Study Completion Date: July 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
SLEEP-E Dyads Sleep Hygiene and Cognitively Based Compassion Training Intervention
Behavioral: SLEEP-E Dyads Sleep Hygiene and Cognitively Based Compassion Training
Adaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition to the adaptive prescriptions, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum and compassion meditation training delivered by the E-Tablets.
No Intervention: Usual Care Group
During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Care recipient must be age 60 and over and require assistance from the identified caregiver with more than one Activity of Daily Living or three or more Instrumental Activities of Daily Living,
  • have a life expectancy of greater than or equal to six (6) months,
  • have no plans for transitioning out of home in the next six months,
  • and have approval from the primary care provider to participate in the research.
  • Caregivers must live with care recipient
  • Caregivers must obtain a negative mini-cog assessment or negative TICS-m assessment. Caregivers can be any relation (spouse, child, sibling, friend, etc.) to the care recipient so long as the two are cohabitating.
  • Caregiver can be any age.
  • For Phase 2 and Phase 3 of the study, either the care recipient or the caregiver must have difficulty sleeping as indicated by scores on the Insomnia Severity Index.

Exclusion Criteria:

  • Parkinson's with tremor or other movement disorder that would invalidate actigraphy
  • Untreated diagnosis of sleep apnea or restless leg syndrome
  • Inability to tolerate actigraphy
  • CG and CR sleep efficiency > 85% and/or both members of dyad report sleeping well
  • Caregivers must have a negative screen with the Mini-Cog or the TICS-m to demonstrate cognitive capacity to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02057068

United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
VA Office of Research and Development
Emory University
Principal Investigator: Patricia C Griffiths, PhD Atlanta VA Medical and Rehab Center, Decatur, GA
  More Information

Responsible Party: VA Office of Research and Development Identifier: NCT02057068     History of Changes
Other Study ID Numbers: E7249-W 
Study First Received: January 24, 2014
Last Updated: August 24, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
Sleep Disorders
Cognitive Behavioral Therapy
Technology processed this record on October 21, 2016