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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site
South Brooklyn Health
Brooklyn, New York, 11235
Marina Ivanyuk, MD, 718-616-3000, marina.ivanyuk@nychhc.org
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 group | Role | What they receive |
|---|---|---|
| Vocal Expression | Active comparator | Supportive care through vocal expression sessions where participants can talk for approximately 20-30 minutes about the person who died. Receives: Behavioral: Vocal Expression |
| Cognitive Behavioral | Experimental | Cognitive-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.
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
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)
Change in Patient Health Questionnaire-9 from Baseline
Depressive symptoms questionnaire of 9 items
Measured: 3 months
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.
- First posted24 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BereavementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- New York City Health and Hospitals Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Ivanyuk, New York City Health and Hospitals Corporation
- Investigators
- Marina Ivanyuk, MD, Principal investigator, New York City Health and Hospitals Corporation
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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Palliative Bereavement Support Program in a Community Hospital Setting
- ClinicalTrials.gov ID
- NCT05826145
- Acronym / sponsor ID
- MED2022-101
- Conditions
- Bereavement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide a palliative bereavement support program for caregivers to decrease the risk for developing complicated and persistent grief.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The control group will receive supportive care through vocal expression sessions. The treatment group will receive supportive care through cognitive-behavioral techniques.
| Arm | Type | Receives |
|---|---|---|
| Vocal Expression | Active comparator | Behavioral: Vocal ExpressionSupportive care through vocal expression sessions where participants can talk for approximately 20-30 minutes about the person who died. |
| Cognitive Behavioral | Experimental | Behavioral: Cognitive BehavioralCognitive-behavioral techniques with sessions consisting of approximately 20-30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vocal ExpressionThere 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. | Behavioural | Vocal Expression |
| Cognitive BehavioralThere 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. | Behavioural | Cognitive Behavioral |
Primary outcome
Change in Bereavement Experience Questionnaire (BEQ-24) from Baseline
Time frame: 3 months
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.
Change in Bereavement Experience Questionnaire (BEQ-24) from Baseline
Time frame: 6 months
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.
2 secondary outcomes
Change in Patient Health Questionnaire-9 from Baseline
Time frame: 3 months
Change in Patient Health Questionnaire-9 from Baseline
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Ivanyuk, MD principal investigator
New York City Health and Hospitals Corporation
1 site in 1 country: see every site and its status.
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.