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BereavementNCT05826145

Bereavement Support Program for Caregivers

A study testing Vocal Expression and Cognitive Behavioral in people with Bereavement, run by New York City Health and Hospitals Corporation at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To provide a palliative bereavement support program for caregivers to decrease the risk for developing complicated and persistent grief. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Bereavement
What is being tested?
Vocal Expression and Cognitive Behavioral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Apr 2023to Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Marina Ivanyuk, MD contact

718-616-3000

marina.ivanyuk@nychhc.org

United States1 site
  • South Brooklyn Health

    Brooklyn, New York, 11235

    Marina Ivanyuk, MD, 718-616-3000, marina.ivanyuk@nychhc.org

Other trials in United States

About this study

Official title: A Palliative Bereavement Support Program in a Community Hospital Setting

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

Read the detailed description

The investigators plan to enroll 50 participants with 25 in each of the two supportive counseling groups from those caregivers of patients treated at South Brooklyn Health. Caregivers will be approached to participate in our psychosocial support program. For those who meet screening and consent to participate, participants will be randomized into one of the two supportive counseling groups.

The control group will receive supportive care through vocal expression sessions where participants can talk for approximately 20-30 minutes about the person who died. The counselor will be supportive and listen to this expressed content. 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. During the first session, participants will complete the questionnaire inquiring about demographic information, the Bereavement Experience Questionnaire (BEQ-24), and the Patient Health Questionnaire-9 (PHQ-9). Additional questionnaires at 3 months (week 12) and 6 months will ask participants to complete the BEQ-24 and the PHQ-9.

The treatment group will receive supportive care through cognitive-behavioral techniques with sessions consisting of approximately 20-30 minutes. 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. Session 1 will consist of completing the baseline questionnaire and by beginning the intervention by completing a grief monitoring diary and assigning it as homework. Session 2 will review the grief monitoring diary together with the participant. The counselor will examine potential triggers when grief was bothersome and examine times when grief was manageable. The goal is to look for and discuss these patterns with the participant. The grief monitoring diary will be assigned again as homework. The participant will be informed to have a recording device (eg, tape recorder) for the next session. Session 3 will teach imaginal revisiting and also review again the grief monitoring diary as above in session 2. Homework will be assigned of practicing imaginal revisiting. Session 4 will review practicing imaginal revisiting. The participant will be taught about cognitive restructuring of negative thought processes/maladaptive attitudes related to bereavement/grief. The participant will be taught about self-monitoring and assigned it as homework. Session 5 will review self-monitoring, continue cognitive restructuring, and assign homework of self-monitoring. Session 6 will review self-monitoring and teach a new concept of describing positive memories of the deceased. Homework will be assigned of thinking more about positive memories of deceased. Session 7 will review homework of thinking more about positive memories of deceased. A new concept of teaching about identifying future goals will be taught. Session 8 will review the homework of identifying future goals. A new concept of teaching relapse prevention strategies for high risk-times will be taught. During the first session, participants will complete the questionnaires inquiring about demographic information, the BEQ-24, and the PHQ-9. Additional questionnaires at 3 months (week 12) and 6 months will ask participants to complete the BEQ-24 and the PHQ-9.

Conditions
Bereavement
Being tested
Vocal Expression, Cognitive Behavioral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vocal ExpressionBehavioural

    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.

  • Cognitive BehavioralBehavioural

    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.

Study groups in NCT05826145
Study groupRoleWhat they receive
Vocal ExpressionActive comparatorSupportive care through vocal expression sessions where participants can talk for approximately 20-30 minutes about the person who died.
Receives: Behavioral: Vocal Expression
Cognitive BehavioralExperimentalCognitive-behavioral techniques with sessions consisting of approximately 20-30 minutes.
Receives: Behavioral: Cognitive Behavioral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  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.

    Measured: 6 months

Secondary outcomes (2)
  1. Change in Patient Health Questionnaire-9 from Baseline

    Depressive symptoms questionnaire of 9 items

    Measured: 3 months

  2. Change in Patient Health Questionnaire-9 from Baseline

    Depressive symptoms questionnaire of 9 items

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2023
  2. Study startApr 2023 (estimated)
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The control group will receive supportive care through vocal expression sessions. The treatment group will receive supportive care through cognitive-behavioral techniques.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05826145
Sponsor's protocol ID
MED2022-101
Status last verified
Apr 2023
First submitted
9 Apr 2023
Last updated
24 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not plan to share individual participant data with other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Vocal Expression and Cognitive Behavioral in people with Bereavement, run by New York City Health and Hospitals Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marina Ivanyuk, MD (718-616-3000, marina.ivanyuk@nychhc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Bereavement Experience Questionnaire (BEQ-24) from Baseline (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.

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