Caregiver Stress and Sleep Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Morning Action Plan Execution
BehavioralEach day, participants are asked to track if they do the morning activity plan.
Activity Strategy-based Session with Therapist
BehavioralParticipants 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.
Attention-based Session with Therapist
BehavioralParticipants 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
Advance sleep-wake time
BehavioralSome 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.)
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Active condition (SAMM Protocol)Experimental treatment 3 interventions
Group B: Attention-matched supportive control conditionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in rumination at 6-months
Rumination will be measured using the rumination subscale of the Behavioral Activation Scale for Depression (BASD). There is a minimum possible score of 0 and a maximum possible score of 24 with higher scores indicating higher \[worse\] rumination. This measure will be accessed via Ecological Momentary Assessment (EMA). A link will be sent to participant's mobile device by text message cuing participants to respond
Time frame
Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)2
Change from baseline in depressive symptoms at 6-months
Depression will be measured using the Patient Health Questionnaire (PHQ-9). There is a minimum possible score of 0 and a maximum possible score of 27 with higher scores indicating higher \[worse\] depression.
Time frame
Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)3
Change from baseline in anxiety symptoms at 6-months
Anxiety will be measured using the Generalized Anxiety Disorder 7-Item Scale (GAD-7). There is a minimum possible score of 0 and a maximum possible score of 21 with higher scores indicating higher \[worse\] anxiety.
Time frame
Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)4
Change in objective Morning Activation Deficits (MADs) over 1 week
Morning activation deficits (MADs), a common component of depression measurable as actigraphy assessed morning inactivity.
Time frame
Continuously for up to 1-week at baselineSecondary outcomes
1
Change in self-report nocturnal mentation at 6-months
Nocturnal mentation will be assessed using the nocturnal mentation subscale of Dream Recall Frequency Scale. There is a minimum possible score of 0 and a maximum possible score of 24 with higher scores \[better\] indicating less negative thoughts/feelings.
Time frame
Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)2
Change in self-report reward anticipation at 6-months
Reward anticipation will be assessed using the a custom measure (e.g., "How much do you anticipate that your upcoming activities/things you do will be rewarding?"). There is a minimum possible score of 0 and a maximum possible score of 27 with higher scores indicating a higher degree of reward anticipation.
Time frame
Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)3
Change in self-report apathy at 6-months
Apathy will be assessed using the Apathy Evaluation Scale. There is a minimum possible score of 18 and a maximum possible score of 72 with higher scores indicating a less apathy \[better\].
Time frame
Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)4
Change in morning light exposure at 6-weeks
Light exposure will be assessed as lux levels in the morning from sensors on the actigraph
Time frame
Baseline and 6-weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov