What is the mechanism of action of this treatment?

Positive Emotion-Based Interventions for caregivers focus on enhancing positive emotions to reduce caregiver burden and improve quality of life. These treatments work by promoting activities that increase positive affect, such as gratitude exercises, mindfulness practices, and engaging in enjoyable activities. By fostering positive emotions, these interventions help mitigate stress, anxiety, and depression, which are common among caregivers. This is crucial as it not only improves the mental and emotional well-being of caregivers but also enhances their ability to provide effective care for their loved ones.

What side effects are associated with this type of intervention?

Common treatments for caregivers that focus on enhancing positive emotions, such as cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR), generally have minimal side effects. Some individuals may experience temporary increases in anxiety or emotional discomfort as they confront and process difficult emotions. Additionally, there may be initial frustration or fatigue as they learn and practice new techniques. However, these side effects are typically mild and transient, making these interventions well-tolerated and beneficial for improving caregiver well-being.

What prior FDA approvals exist?

There are no specific FDA-approved treatments that directly target enhancing positive emotions to reduce caregiver burden. However, related treatments that focus on psychological well-being and stress reduction, such as cognitive-behavioral therapy (CBT) and certain antidepressants like SSRIs (e.g., sertraline, fluoxetine), have been used to support caregivers by improving their mental health. These treatments aim to alleviate symptoms of depression and anxiety, which can indirectly reduce caregiver burden and improve quality of life.

What other types of research exist?

<ol> <li>Mindfulness-Based Stress Reduction (MBSR): An eight-week, evidence-based group intervention that uses meditation practices to increase awareness and learn self-regulation strategies, which can help reduce stress and improve quality of life for caregivers.</li> <li></li> </ol> Guided Imagery and Progressive Muscle Relaxation: These techniques have been shown to reduce pain and improve psychological well-being in various patient populations, including caregivers. 3. Cognitive-Behavioral Therapy (CBT): This approach can help caregivers manage stress, anxiety, and depression by changing negative thought patterns and behaviors. 4. Biofeedback: Techniques such as EMG biofeedback-assisted relaxation have shown promise in reducing pain and stress, which could be beneficial for caregivers dealing with high levels of burden.

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Positive Psychology Intervention for Caregivers of Blood Cancer Patients (PATH-C Trial)

N/A

Waitlist Available

Led By Hermioni L Amonoo, MD, MPP, MPH

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program that uses activities to make caregivers of cancer patients feel happier and less stressed. The goal is to improve their health and quality of life by boosting positive emotions.

Who is the study for?

This trial is for adult caregivers (18+ years) of patients undergoing allogeneic stem cell transplant at DCFI. They must speak English, be able to complete questionnaires with minimal help, and have close contact with the patient at least twice a week. Caregivers with cognitive deficits that affect their ability to consent or participate are excluded.

What is being tested?

The study tests a Positive Psychology Intervention aimed at reducing caregiver burden by enhancing positive emotions among those caring for blood cancer patients receiving stem cell transplants. It seeks to improve caregivers' quality of life and health outcomes.

What are the potential side effects?

Since this intervention focuses on psychological support rather than medication, traditional physical side effects are not expected. However, participants may experience emotional responses as they engage in the program.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Acceptability Rate

Feasibility of the PATH Intervention

Secondary study objectives

Feasibility and acceptability of the PATH intervention assessed by participant ratings of ease and utility on a 10 point likert scale after each weekly intervention session

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: PATH InterventionExperimental Treatment1 Intervention

Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. After consent procedures, participants will begin an 9-week positive-psychology program involving weekly calls with an interventionist and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). Self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positive Psychology Intervention

2022

N/A

~190

Do I qualify?Apply below to find out

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

Positive Emotion-Based Interventions for caregivers focus on enhancing positive emotions to reduce caregiver burden and improve quality of life. These treatments work by promoting activities that increase positive affect, such as gratitude exercises, mindfulness practices, and engaging in enjoyable activities. By fostering positive emotions, these interventions help mitigate stress, anxiety, and depression, which are common among caregivers. This is crucial as it not only improves the mental and emotional well-being of caregivers but also enhances their ability to provide effective care for their loved ones.