Psychotherapy for Caregiver Burden

Recruiting at 7 trial locations

Overseen By Morgan Loschiavo, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Lack of study understanding, Ongoing psychotherapy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 7 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of therapy can help caregivers find meaning and manage stress. Participants will receive either Meaning-Centered Psychotherapy for Caregivers (MCP-C) or Supportive Psychotherapy for Caregivers (SP-C) over seven sessions. The trial collects feedback on emotional well-being and social support before, during, and after these sessions. It suits caregivers of loved ones with advanced-stage cancer who feel stressed and live in New York, New Jersey, or Florida. As an unphased trial, this study offers caregivers a unique opportunity to contribute to research that could enhance support strategies for others in similar situations.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently engaged in regular individual psychotherapy, you may need to pause it during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Meaning-Centered Psychotherapy for Caregivers (MCP-C) helps reduce deep emotional stress, a significant challenge for caregivers. Although specific safety data on side effects from past studies is lacking, talk therapies like MCP-C are generally considered safe. They do not involve medication or physical procedures, so people usually tolerate them well.

Participants in studies have not reported serious negative effects from MCP-C, suggesting the therapy is likely safe for most people. The same applies to Supportive Psychotherapy for Caregivers (SP-C), a widely used support method for caregivers without major safety concerns. Both therapies aim to help caregivers manage stress and improve their well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these psychotherapy treatments for caregiver burden because they offer unique approaches compared to traditional support methods. Meaning-Centered Psychotherapy for Caregivers focuses on helping caregivers find personal meaning and purpose in their roles, which could provide deeper emotional resilience than standard support therapies. On the other hand, Supportive Psychotherapy for Caregivers serves as a valuable comparison, offering the standard care that emphasizes emotional support and coping strategies. By exploring these distinct approaches, researchers hope to understand which method better alleviates caregiver stress and enhances well-being.

What evidence suggests that this trial's treatments could be effective for caregiver burden?

Research shows that Meaning-Centered Psychotherapy for Caregivers (MCP-C), one of the therapies tested in this trial, can reduce caregiver stress by addressing deep emotional concerns. This therapy helps caregivers find meaning and purpose, boosting their emotional health. Studies have found that caregivers participating in MCP-C often feel less depressed and anxious. Meanwhile, Supportive Psychotherapy for Caregivers (SP-C) is another therapy option in this trial. Although less information exists on SP-C, it is a common method that aims to provide emotional support and improve coping skills. Both therapies can benefit those dealing with caregiver stress. ^{1 2 3 6 7}

Who Is on the Research Team?

Allison Applebaum, PhD, FAPOS

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for caregivers experiencing stress, burnout, or burden from caring for someone with cancer. Participants should be willing to undergo psychotherapy and complete several questionnaires before and after therapy sessions.

Inclusion Criteria

Residing in New York, New Jersey, or Florida, or have the ability to complete sessions while complying with current telehealth regulations

I am caring for someone with advanced cancer.

Experiences distress with a score of 4 or greater on the Distress Thermometer related to caregiving

Exclusion Criteria

I don't fully understand what participating in the study involves.

I am currently in ongoing therapy that I cannot pause.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive either Meaning-Centered Psychotherapy for Caregivers (MCP-C) or Supportive Psychotherapy for Caregivers (SP-C) for 7 sessions

7 weeks

7 visits (in-person)

Follow-up

Participants complete additional sets of questionnaires about 2 weeks, 6 months, and 12 months after their last session to monitor maintenance of treatment gains

12 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Meaning-Centered Psychotherapy for Caregivers
• Supportive Psychotherapy for Caregivers

Trial Overview The study compares two types of therapy: Meaning-Centered Psychotherapy (MCP-C) and standard Supportive Psychotherapy (SP-C). Caregivers will be randomly assigned to one of these therapies for seven sessions, followed by evaluations over a year.

How Is the Trial Designed?

Group I: Meaning-Centered Psychotherapy for Caregivers Experimental Treatment 1 Intervention

Meaning-Centered Psychotherapy for Caregivers/MCP-C

Group II: Supportive Psychotherapy for Caregivers Active Control 1 Intervention

Supportive Psychotherapy for Caregivers/SP-C standard of care

Meaning-Centered Psychotherapy for Caregivers is already approved in United States for the following indications:

Approved in United States as MCP-C for:

• Support for caregivers of cancer patients

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

University of Miami Sylvester Comprehensive Cancer Center

Collaborator

Trials

11

Recruited

2,700+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) is designed to address existential distress, a significant but often overlooked aspect of caregiver burden in those caring for patients with advanced cancer.

A case study from an initial MCP-C group revealed that participants experienced personal growth, improved self-care, and a deeper understanding of their caregiving experience, highlighting the potential benefits of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C): Rationale and Overview. Applebaum, AJ., Kulikowski, JR., Breitbart, W.[2022]

A case study involving a patient with Glioblastoma Multiforme and his caregiver showed that concurrent engagement in Meaning-Centered Psychotherapy (MCP) and Meaning-Centered Psychotherapy for Caregivers (MCP-C) led to enhanced well-being for both individuals.

Both the patient and caregiver experienced increased connectedness and improved coping with existential distress, suggesting that simultaneous participation in these therapies may provide unique benefits that warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits of concurrent engagement in meaning-centered psychotherapy and meaning-centered psychotherapy for cancer caregivers: A case study. Roberts, KE., Applebaum, AJ.[2023]

Meaning-centered psychotherapy (MCP) was found to significantly reduce anxiety and depression in patients with pancreatobiliary cancer after four therapy sessions, with improvements noted at a 2-month follow-up.

Patients who underwent MCP also experienced a notable enhancement in their quality of life, while those who did not receive MCP showed no significant changes, highlighting the potential effectiveness of this therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Findings on the Effectiveness of Meaning-Centered Psychotherapy in Patients with Pancreatobiliary Cancer. Ryu, JS., Choi, SW., Yun, SS., et al.[2018]

The pilot study involving 30 patients with advanced cancer showed that Meaning-Centered Psychotherapy and Essential Care (MCP-EC) significantly reduced symptoms of anxiety, depression, and hopelessness, while enhancing spiritual well-being and a sense of meaning.

Patients reported high satisfaction with the MCP-EC intervention, indicating its feasibility and acceptability compared to usual psychological support, although further research with larger samples is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An adaptation of meaning-centered psychotherapy integrating "essential care": A pilot study. Quílez-Bielsa, E., Barrado-Moreno, V., Lastra Del Prado, R., et al.[2022]

The Care for the Cancer Caregiver (CCC) Workshop, a web-based adaptation of Meaning-Centered Psychotherapy, was found to be feasible and acceptable for cancer caregivers, with 84 participants randomized to either the workshop or a waitlist control.

While no significant differences were observed between groups in most measures, caregivers in the CCC Workshop showed significant increases in benefit finding, suggesting that the program may help enhance caregivers' sense of meaning and purpose over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the cancer caregiver's journey through web-based Meaning-Centered Psychotherapy. Applebaum, AJ., Buda, KL., Schofield, E., et al.[2021]

A study involving 51 cancer inpatients found that a Meaning-Centered Psychotherapy Model tailored for palliative care, especially with compassion elements, is feasible and acceptable for patients in their final weeks of life.

Patients reported that key elements like meaning, self-compassion, and legacy were particularly helpful, suggesting that these constructs can aid in coping with the dying process, although further research with larger samples is needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-centered psychotherapy integrated with elements of compassion: A pilot study to assess feasibility and utility. Gil, F., Fraguell, C., Benito, L., et al.[2019]

In a study involving 170 cancer survivors, meaning-centered group psychotherapy for cancer survivors (MCGP-CS) was found to be more cost-effective than care-as-usual (CAU), with lower total costs (€4492 for MCGP-CS vs. €5304 for CAU) and higher quality-adjusted life years (QALYs) at 0.540 compared to 0.507 for CAU.

MCGP-CS had a 74% probability of being both less costly and more effective than CAU, and a 49% probability compared to supportive group psychotherapy (SGP), indicating strong evidence for its economic and therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-utility analysis of meaning-centered group psychotherapy for cancer survivors. van der Spek, N., Jansen, F., Holtmaat, K., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26000705/

Meaning-Centered Psychotherapy for Cancer Caregivers ... None, however, target existential distress, a critical, common element - and potentially driving mechanism - of caregiver burden. ... burden among cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5084449/

Preliminary study of themes of meaning and psychosocial ... The purpose of this study was to collect preliminary descriptive data regarding caregiver burden, meaning, and psychosocial service use

3. academia.edu academia.edu/80054064/Meaning_Centered_Psychotherapy_for_Cancer_Caregivers_MCP_C_Rationale_and_Overview

Meaning-Centered Psychotherapy for Cancer Caregivers ... EXISTENTIAL DISTRESS AMONG CANCER CAREGIVERS A critical, potential driving, element of caregiver burden is existential distress. While no one Author ...

4. withpower.com withpower.com/trial/phase-3-caregiver-burden-1-2024-3d69c

Psychotherapy for Caregiver Burden How is Meaning-Centered Psychotherapy for Caregivers different from other treatments for caregiver burden? Meaning-Centered Psychotherapy for Caregivers (MCP-C) ...

5. researchgate.net researchgate.net/publication/358146658_A_qualitative_exploration_of_the_feasibility_and_acceptability_of_Meaning-Centered_Psychotherapy_for_Cancer_Caregivers

A qualitative exploration of the feasibility and acceptability ... Online databases were searched for studies that evaluated caregiver burden in adult caregivers of HSCT patients since 2010 (the publication ...

6. amazon.com amazon.com/Meaning-Centered-Psychotherapy-Cancer-Caregivers-Therapist-ebook/dp/B0CV832LMS

Meaning-Centered Psychotherapy for Cancer Caregivers Meaning-Centered Psychotherapy for Cancer Caregivers: Therapist Manual and Caregiver Workbook. See more. ISBN-13: 978-0197640791.

7. ctv.veeva.com ctv.veeva.com/study/a-study-of-meaning-centered-psychotherapy-for-caregivers-to-people-with-cancer

A Study of Meaning-Centered Psychotherapy for Caregivers to ... A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer ... Caregiver Burden. Caregiver Stress Syndrome. Treatments.