Recruiting

Meaning-Centered PsychotherapyA Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06307535

Conditions

Caregiver Burden

Caregiver Burnout

Caregiver Stress Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Meaning-Centered Psychotherapy for Caregivers

Supportive Psychotherapy for Caregivers

Study Details

Brief summary:

Participants will complete 1 set of questionnaires about 2 weeks before beginning their Meaning-Centered Psychotherapy for Caregivers/MCP-C or standard Supportive Psychotherapy for Caregivers/SP-C sessions. These questionnaires will ask about participants' sense of meaning and purpose in life, spiritual well-being, depression and/or anxiety, and social support. Participants will then be assigned to receive either MCP-C or SP-C for 7 sessions. Participants will complete additional sets of questionnaires about 2 weeks, 6 months, and 12 months after their last session of MCP-C or SP-C. It will take between 35 and 50 minutes to complete each set of questionnaires.

After participants complete the MCP-C or SP-C sessions and all 4 sets of questionnaires, their participation in this study will end. If participants decide not to complete all 7 sessions, they may still choose to complete the questionnaires.

Participants may remain in the study and continue to receive all 7 sessions of MCP-C or SP-C even if their loved one passes away.

Conditions

Caregiver Burden

Caregiver Burnout

Caregiver Stress Syndrome

Study ID

NCT06307535

Start date

Mar 13, 2024

Status verified date

May, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Age 18 or over;
As per self-report, a current caregiver to a patient with Stage III or IV solid tumor cancer currently receiving medical care of any kind (e.g., curative, palliative);
Experiences distress as evidenced by a score of 4 or greater on the Distress Thermometer (DT) and an indication that this distress is associated with caregiving;
As per self-report, can read and understand English;
As per self-report, residing in New York, New Jersey, Connecticut, or Florida, or have the ability to complete sessions while complying with current telehealth regulations.

Exclusion Criteria:

Participant does not have a reasonable understanding of the study activities by the judgment of the consenting professional;
Engagement in regular individual psychotherapeutic support that the participant is unable or unwilling to put on hold for the course of treatment.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Meaning-Centered Psychotherapy for Caregivers

Meaning-Centered Psychotherapy for Caregivers/MCP-C

active comparator: Supportive Psychotherapy for Caregivers

Supportive Psychotherapy for Caregivers/SP-C standard of care

Interventions

Meaning-Centered Psychotherapy for Caregivers

MCP-C is a stakeholder-informed, innovative, manualized intervention designed to assist caregivers to connect to a sense of meaning and purpose in life, despite the challenges of caregiving.

Supportive Psychotherapy for Caregivers

Standard of care supportive psychotherapy

Primary outcome measure

Number of participants with improved primary outcomes [ Time Frame: Up to 1 year ]
Life Attitude Profile-Revised (LAP-R) [ Time Frame: Up to 1 year ]
FACIT Spiritual Well-Being Scale (SWBS) [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Allison Applebaum, PhD, FAPOS

212-241-8561 allison.applebaum@mssm.edu

Morgan Loschiavo, MPH

646-888-0225 LoschiaM@mskcc.org

Locations

University of Miami (Data Collection AND Data Analysis)

Recruiting

Miami, Florida, United States, 33136

Contacts

Wendy Lichtenthal, PhD

305-243-8983

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Talia Zaider, PhD

646-888-0162 zaidert@mskcc.org

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Talia Zaider, PhD

646-888-0162 zaidert@mskcc.org

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Talia Zaider, PhD

646-888-0162 zaidert@mskcc.org

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Recruiting

Commack, New York, United States, 11725

Contacts

Talia Zaider, PhD

646-888-0162 zaidert@mskcc.org

Memorial Sloan Kettering Westchester (Consent only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Talia Zaider, PhD

646-888-0162 zaidert@mskcc.org

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Talia Zaider, PhD

646-888-0162 zaidert@mskcc.org

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Talia Zaider, PhD

646-888-0162 zaidert@mskcc.org

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

Caregiver
Caregiver Stress Syndrome
Caregiver Burden
Caregiver Burnout
Meaning-Centered Psychotherapy
23-376

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-05-26.