What side effects are associated with this type of intervention?

Behavioral therapies like Cognitive Behavioral Therapy (CBT) are generally well-tolerated with minimal side effects. However, some individuals may experience temporary increases in anxiety or emotional discomfort as they confront challenging thoughts and behaviors. Other potential side effects include fatigue, frustration, or emotional distress during the therapy process. These side effects are typically mild and transient, resolving as therapy progresses.

What prior FDA approvals exist?

There are no specific FDA-approved medications for the treatment of caregiver burden. However, behavioral therapies, such as cognitive-behavioral therapy (CBT), have been studied and shown to be effective in improving mental health outcomes in various conditions. These therapies focus on modifying behavior to alleviate stress and improve coping mechanisms, which can be beneficial for caregivers experiencing significant stress and burden.

What other types of research exist?

Promising novel alternatives to behavioral therapy for caregiver burden patients include: 1) Psilocybin-assisted psychotherapy, which has shown efficacy in treatment-resistant depression and existential distress in life-threatening conditions. 2) MDMA-assisted psychotherapy, which has been approved for expanded access in treating PTSD and may help with severe stress and anxiety. 3) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown improvements in psychological well-being and sleep-related quality of life, potentially alleviating caregiver stress. These therapies offer innovative approaches that could be beneficial for managing caregiver burden.

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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

Must not have

Active Cognitive Behavioral Therapy for mood or insomnia

Unsafe or unable to undergo MRI

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program called SAMM, which helps caregivers of dementia patients plan and track morning activities. The goal is to reduce depression by getting them more active in the morning. Increased morning activity is expected to lower negative thinking and improve brain function related to mood.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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My depression medication has not changed recently.

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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently undergoing Cognitive Behavioral Therapy for mood or sleep issues.

Select...

I cannot have an MRI due to safety or health reasons.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Change in cognitive functioning at 6-weeks

Change in executive function at 6-weeks

Change in morning light exposure at 6-weeks

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral therapies, such as cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT), are common treatments for Caregiver Burden. These therapies work by helping individuals identify and change negative thought patterns and behaviors, and by incorporating mindfulness strategies to focus on the present moment and reduce stress. These mechanisms are crucial for caregivers as they can significantly reduce psychological distress, improve coping strategies, and enhance overall well-being, addressing the high levels of stress and emotional burden that caregivers often face.

A pilot randomized controlled trial of E-care for caregivers: An internet intervention for caregivers of depressed patients.