Compassion Strikes Back

NCT ID: NCT06988995

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-07-31

Brief Summary

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Research has shown that LVAD patients and their caregivers typically experience increased mental health concerns and decreased quality of life following LVAD implantation and hospital discharge. The purpose of this study is to explore how to improve quality of life for LVAD patients and their caregivers in the initial transition from hospital to home after LVAD implantation.

Over the course of the study, participants will complete 2 surveys: one when participants are in the hospital and one at a 2-month post-hospital follow-up appointment with the participants' cardiologist. Participants may be contacted if there is data missing from surveys.

Participants may also be provided with information on improving mental health in the form of handouts or a brief meeting with a psychology provider.

Detailed Description

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Conditions

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LVAD Caregivers LVAD (Left Ventricular Assist Device) Quality of Life (QOL) Self-Compassion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Meeting

Group Type EXPERIMENTAL

Meeting

Intervention Type BEHAVIORAL

Participants meet with a psychological provider to receive information on self-compassion and training on how to utilize self-compassion

Information

Group Type ACTIVE_COMPARATOR

Information

Intervention Type OTHER

Participants provided handouts with information on self-compassion

Interventions

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Information

Participants provided handouts with information on self-compassion

Intervention Type OTHER

Meeting

Participants meet with a psychological provider to receive information on self-compassion and training on how to utilize self-compassion

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* LVAD implantation or caregiver or patient with LVAD; over 18 years old; primary caregiver is a family member

Exclusion Criteria

* Currently or in the past 3 months received psychotherapy or psychosocial or peer support; hospitalized for psychiatric reasons in the past 6 months; current, active suicidal thoughts or a reported suicide attempt within the past year; a current alcohol/substance use disorder that required immediate treatment; or a current or past thought disorder, psychosis, or unmanaged bipolar disorder; enrolled in another investigational research/clinical trial; toxic/negative dynamic between pt and caregiver; extended post-LVAD implantation course (i.e., more than 2 months in the hospital).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Abigail Shonrock, PhD

Role: primary

610-772-6099

Other Identifiers

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IRB202500512

Identifier Type: -

Identifier Source: org_study_id

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