Caregiver Stress and Sleep Study

BEHAVIORAL

Morning Action Plan Execution

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

BEHAVIORAL

Activity 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.

BEHAVIORAL

Attention-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

BEHAVIORAL

Advance 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.)

Change from baseline in rumination at 6-months

Time frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (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

Change from baseline in depressive symptoms at 6-months

Time frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (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.

Change from baseline in anxiety symptoms at 6-months

Time frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (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.

Change in objective Morning Activation Deficits (MADs) over 1 week

Time frame: Continuously for up to 1-week at baseline

Morning activation deficits (MADs), a common component of depression measurable as actigraphy assessed morning inactivity.

Change in self-report Morning Activation Deficits (MADs) at 6-months

Time frame: Baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

Morning Activation Deficits (MADs) will be assessed using the Composite Morningness Questionnaire (CMQ). There is a minimum possible score of 13 and a maximum possible score of 55 with higher scores indicating a higher degree or morningness.

Change in resting-state connectivity at 6-weeks

Time frame: Baseline and 6-weeks

Resting connectivity of the amygdala and ventral posterior cingulate cortex (PCC) structures will be measured by brain imaging conducted with a 7 Tesla scanner

Change in neurological response to rumination cues at 6 weeks

Time frame: Baseline and 6-weeks

Rumination-related brain activation in the Limbic (amygdala), default mode network (DMN), ventral posterior cingulate cortex (PCC), and Frontal Parietal Control Network (FPCN) will be measured by brain imaging conducted with a 7 Tesla scanner.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.