Bereavement Support Program for Caregivers

NCT05826145 | Unknown

• 1 other identifier: MED2022-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To provide a palliative bereavement support program for caregivers to decrease the risk for developing complicated and persistent grief.

Conditions

Bereavement

Outcome Measures

Primary Outcomes (2)

• Change in Bereavement Experience Questionnaire (BEQ-24) from Baseline

  Short form of 24 questions consisting of three subscales of 1) Existential Loss/Emotional Needs, 2) Guilt/Blame/Anger, and 3) Preoccupation with Thoughts of Deceased.

  3 months

• Change in Bereavement Experience Questionnaire (BEQ-24) from Baseline

  Short form of 24 questions consisting of three subscales of 1) Existential Loss/Emotional Needs, 2) Guilt/Blame/Anger, and 3) Preoccupation with Thoughts of Deceased.

  6 months

Secondary Outcomes (2)

• Change in Patient Health Questionnaire-9 from Baseline

  3 months

• Change in Patient Health Questionnaire-9 from Baseline

  6 months

Study Arms (2)

Vocal Expression

ACTIVE COMPARATOR

Supportive care through vocal expression sessions where participants can talk for approximately 20-30 minutes about the person who died.

Behavioral: Vocal Expression

Cognitive Behavioral

EXPERIMENTAL

Cognitive-behavioral techniques with sessions consisting of approximately 20-30 minutes.

Behavioral: Cognitive Behavioral

Interventions

Vocal Expression BEHAVIORAL

There will be a total of 8 sessions. At baseline (week 0), only questionnaires will be completed. There will be 7 treatment sessions beginning at week 2, and the other sessions conducted at approximately every 3 weeks over the 6-month study duration where the vocal expression sessions will be provided.

Vocal Expression

Cognitive Behavioral BEHAVIORAL

There will be 8 treatment sessions where part of the baseline session of session 1 (week 0) will include some instruction, session 2 will occur in week 2, and the other sessions conducted at approximately every 3 weeks over the 6-month study duration. Sessions will include various cognitive-behavioral techniques including completing a grief monitoring diary, imaginal revisiting, cognitive restructuring, describing positive memories of the deceased, and identifying future goals.

Cognitive Behavioral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informal family (or friend) caregivers, who are 18 years and older, who are caring for patients 18 years and older.
• Patient location may include the emergency department, or inpatient settings when patients are referred to Palliative Care services for end-of-life care.
• Caregivers for patients who die at the hospital are included in this study.
• Only will include those who speak English.

You may not qualify if:

• Caregivers or patients under the age of 18.
• Pregnant caregivers.
• Court appointed guardians.
• Caregivers who have history of psychiatric illness, high depression scores on the PHQ-9 (\>20), suicidal ideation, or anxiety symptoms of panic attacks on initial screening will not be included and will be provided contact information to obtain treatment at Behavioral Health.

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

South Brooklyn Health

Brooklyn, New York, 11235, United States

Location

Study Officials

• Marina Ivanyuk, MD

  New York City Health and Hospitals Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Ivanyuk, MD

CONTACT

718-616-3000; marina.ivanyuk@nychhc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Palliative Care

Model Details: The control group will receive supportive care through vocal expression sessions. The treatment group will receive supportive care through cognitive-behavioral techniques.

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: April 24, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)