RightFit
RecruitingNot applicable

Caregiver Stress and Sleep Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will complete surveys about their caregiving experiences, health, and mood, undergo an MRI, and wear an actigraphy watch that measures activity levels throughout the day and when sleeping."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how stress, sleep, and activity may affect mood and brain health in unpaid caregivers age 55 or older who care for someone with dementia. It compares two talk therapies, with treatment chosen by chance. Participants will answer surveys, have an MRI brain scan, and wear a watch that tracks activity and sleep.

The purpose of this research study is to better understand how stress, sleep and activity might impact caregivers' mood and brain health. This study includes a randomized experimental component where therapists will systematically deliver one of two evidence-based talk-therapy treatments. The aim is to evaluate effects on meaningful health-relevant measures including morning activation levels, depression symptoms, rumination, and aspects brain connectivity previously linked with depression. Participants will complete surveys about their caregiving experiences, health, and mood, undergo an MRI, and wear an actigraphy watch that measures activity levels throughout the day and when sleeping.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 55 or older.
  • Give at least 15 hours of unpaid care each week to someone diagnosed with dementia.
  • Feel stress or strain from caregiving.
  • Take no medicine for depression, or have a stable depression medicine treatment.
  • Meet the study's survey rules for trouble getting going in the morning or a strong preference for mornings.

Who can't join

  • Cannot safely have an MRI scan or are unable to have one.
  • Are currently getting cognitive behavioral therapy, a type of talk therapy, for mood or trouble sleeping.
  • Likely have dementia, a condition that affects memory and thinking.
  • Have a life-threatening illness or plan to leave the study area.
  • Currently have a substance use disorder, meaning alcohol or drug use that causes serious problems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 55 years or older. * Provide at least 15 hours/week of unpaid care to a patient with a dementia diagnosis. * Reporting stress or strain delivering care * No or stable pharmacotherapy for depression * Meets screening definition for having morning activation difficulty or a definite morning type per the Composite Morningness Questionnaire (CMQ) Exclusion Criteria: * Unsafe or unable to undergo MRI * Active Cognitive Behavioral Therapy for mood or insomnia * Probable dementia diagnosis * Deadly illness or plans to leave the study area * Current active substance use disorder

Study sites (1)

PA