An interventional study of Vocal Expression and Cognitive Behavioral in Bereavement, sponsored by New York City Health and Hospitals Corporation. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-24.
Sponsored by New York City Health and Hospitals Corporation · Not applicable, Interventional, and Supportive care
To provide a palliative bereavement support program for caregivers to decrease the risk for developing complicated and persistent grief.
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.
New York City Health and Hospitals Corporation is the lead sponsor of 28 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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 techniques with sessions consisting of approximately 20-30 minutes.
Behavioral: Cognitive 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.
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.
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.
Time frame: 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.
Time frame: 6 months
Change in Patient Health Questionnaire-9 from Baseline
Depressive symptoms questionnaire of 9 items
Time frame: 3 months
Change in Patient Health Questionnaire-9 from Baseline
Depressive symptoms questionnaire of 9 items
Time frame: 6 months
Plan to share: No — We do not plan to share individual participant data with other researchers.
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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New York City Health and Hospitals Corporation