RecruitingNot ApplicableNCT05219955

Caregiver Stress and Sleep Study


Sponsor

University of Pittsburgh

Enrollment

120 participants

Start Date

Jul 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study includes a randomized experimental component where therapists will systematically deliver an experimental behavioral probe or a supportive control condition. 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.


Eligibility

Min Age: 60 Years

Inclusion Criteria5

  • Age 60 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 types per the Composite Morningness Questionnaire (CMQ)

Exclusion Criteria5

  • 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

Interventions

BEHAVIORALMorning Action Plan Execution

Each day, participants are asked to track if they do the morning activity plan.

BEHAVIORALActivity Strategy-based Session with Therapist

Participants will meet weekly with a trained therapist to discuss their prescribed activity plan. If unsuccessful, at weekly follow-ups, participants are asked to refine their plan or make a new one. Each session lasts about 30-45 minutes.

BEHAVIORALAttention-based Session with Therapist

Participants will meet weekly with trained a therapist to talk about stressors they experience, providing an opportunity to voice and self-address their problems. In this control condition, therapists will not deliver any particular strategy except for active listening and referring to the educational materials

BEHAVIORALAdvance sleep-wake time

Some participants will be asked to adjust their sleep schedule to accommodate morning activity engagement by introducing or altering mechanisms known promote early rising (i.e., light exposure, reward and processes, etc.)


Locations(1)

UPMC Western Behavioral Health

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05219955


Related Trials