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Therapy for Caregiver Depression (CARES Trial)

N/A

Recruiting

Led By Stephen F Smagula, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No or stable pharmacotherapy for depression

Age 60 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

Awards & highlights

CARES Trial Summary

This trial will test two different types of therapy to see which is more effective in treating depression.

Who is the study for?

This study is for individuals aged 60 or older who are unpaid caregivers to someone with dementia, feeling stressed, and have trouble getting going in the morning. They shouldn't be currently receiving cognitive therapy, have a substance use disorder, probable dementia themselves, or any condition that prevents MRI scans.Check my eligibility

What is being tested?

The trial tests whether certain interventions like adjusting sleep-wake times and morning routines can help reduce depression symptoms and improve brain function related to mood in caregivers experiencing stress.See study design

What are the potential side effects?

Since this trial involves behavioral strategies rather than medications, side effects may include emotional discomfort or fatigue due to changes in routine but are not expected to involve physical health risks.

CARES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My depression medication has not changed recently.

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I am 60 years old or older.

CARES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, continuously up to weekly for 6-weeks, and follow-up (6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, continuously up to weekly for 6-weeks, and follow-up (6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in anxiety symptoms at 6-months

Change from baseline in depressive symptoms at 6-months

Change from baseline in rumination at 6-months

+4 more

Secondary outcome measures

Change in cognitive functioning at 6-weeks

Change in executive function at 6-weeks

Change in morning light exposure at 6-weeks

+3 more

CARES Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active condition (SAMM Protocol)Experimental Treatment3 Interventions

The goal of the SAMM protocol is to increase morning activity engagement over a 6-week period. Participants in this condition will review their morning routine, and make a list of potential morning activities to add. They will choose one activity and develop a plan for doing it. Each day, participants are asked to track if they do the morning activity plan. If unsuccessful, at weekly follow-ups, participants are asked to refine their plan or make a new one.

Group II: Attention-matched supportive control conditionActive Control1 Intervention

Participants in this condition will receive sessions in the same number and duration as the SAMM experimental condition. Therapists will create a comfortable environment by demonstrating interest, empathy, and acceptance without judgment. Caregivers will be encouraged 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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

16,342,826 Total Patients Enrolled

1 Trials studying Caregiver Burden

150 Patients Enrolled for Caregiver Burden

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,647 Total Patients Enrolled

Stephen F Smagula, PhDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Activity Strategy-based Session with Therapist Clinical Trial Eligibility Overview. Trial Name: NCT05219955 — N/A

Caregiver Burden Research Study Groups: Active condition (SAMM Protocol), Attention-matched supportive control condition

Caregiver Burden Clinical Trial 2023: Activity Strategy-based Session with Therapist Highlights & Side Effects. Trial Name: NCT05219955 — N/A

Activity Strategy-based Session with Therapist 2023 Treatment Timeline for Medical Study. Trial Name: NCT05219955 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being chosen to participate in this trial?

"Affirmative, according to clinicaltrials.gov this trial's recruitment status is open. It was first advertised on July 15th 2022 and the details were most recently revised on September 6th 2022; it requires 120 participants at one location."

Answered by AI

Is this trial currently admitting participants?

"As noted on clinicaltrials.gov, this research is presently recruiting volunteers; it was initially posted on July 15th 2022 and its details were last revised on September 6th of the same year."

Answered by AI

What aims does this clinical experiment seek to accomplish?

"The primary objective of this trial, which will be observed at Baseline, up to weekly for 6-weeks, and follow-up (6 months), is assessing the Variation in self-reported Morning Activation Deficits (MADs) after half a year. Secondary parameters include Alterations in executive function measured with Stroop Neuropsychological Screening Test that assesses one's capacity to regulate inhibition within 120 seconds; Modification in anticipated reward determined by a custom measure inquiring about upcoming activities anticipation; and Adjustment in apathy level gauged through Apathy Evaluation Scale ranging from 18 to 72 scores where higher numbers"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Caregiver Stress and Sleep Study

Stephen Smagula 2022. "Caregiver Stress and Sleep Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05219955.