Grief Counseling for Bereaved Parents

Overseen By Talia Zaider, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Significant psychiatric disturbance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 32

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new counseling program for parents who have lost a child, aiming to help them manage their grief. It tests two types of therapy: Meaning-Centered Grief Therapy (MCGT) and Supportive Psychotherapy (SP). Participants receive 16 weekly sessions, either in person or via video, to determine which approach provides more effective emotional support. Those who lost a child at least six months ago and live in New York or nearby states might be a good fit. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance support for grieving parents.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on counseling, so it's likely you can continue your medications, but please confirm with the study team.

What prior data suggests that this counseling program is safe for bereaved parents?

Research has shown that Meaning-Centered Grief Therapy (MCGT) has been studied with parents who have lost a child. These studies suggest that MCGT is generally well-received and may improve both mental and physical health for grieving parents. Although specific details about side effects are not provided, the focus on enhancing emotional well-being suggests it is a safe option for participants.

Supportive Psychotherapy (SP) has also been researched as a way to help people cope with grief. While the quality of evidence varies, many studies report improvements in emotional health, indicating that SP is generally safe and well-tolerated, with no major side effects noted.

Both treatments aim to offer emotional support and coping strategies, making them promising options for parents seeking help after losing a child. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Meaning-Centered Grief Therapy (MCGT) and Supportive Psychotherapy (SP) for bereaved parents because these therapies focus specifically on finding meaning and emotional support during grief, which is different from traditional treatments like medication or cognitive-behavioral therapy. MCGT is distinctive because it helps parents explore personal values and life purpose, potentially offering a deeper connection to their loss and a sense of healing. Additionally, both MCGT and SP are delivered through videoconferencing, making them more accessible to parents who might not be able to attend in-person sessions. This approach not only broadens access to care but also allows parents to engage in therapy from the comfort of their own homes.

What evidence suggests that this trial's treatments could be effective for grief counseling?

Research has shown that Meaning-Centered Grief Therapy (MCGT), one of the therapies studied in this trial, can help parents who have lost a child by reducing long-lasting grief and depression. In one study, 75% of participants attended all sessions, indicating strong interest in the therapy. MCGT aims to improve the mental and physical health of grieving parents, especially those who lost a child to cancer.

Supportive Psychotherapy (SP) is another approach evaluated in this trial that helps people cope with grief. Studies have found that in-person therapies like SP effectively manage complicated grief. SP provides emotional support and helps individuals work through their loss. Both therapies offer valuable support for grieving parents, and participants in this trial will be randomized to receive either MCGT or SP. ^{1 2 3 5 6}

Who Is on the Research Team?

Talia Zaider, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for parents in certain areas of New York, New Jersey, Connecticut, or Pennsylvania who have lost a child and are struggling with grief. They must be at least 18 years old, speak English well enough to complete study tasks, and have been grieving for at least six months.

Inclusion Criteria

Score of 34 or greater (≥ 34) on the PG-13 at screening (N/A for training case participants)

Residing in New York, New Jersey, Connecticut, or Pennsylvania for P1S1; Residing in New York for P1S2; residing in New York or New Jersey or able to complete sessions while complying with current telehealth regulations.

I am the child's biological, adoptive, or stepparent.

Exclusion Criteria

Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude completion of the assessment measures, interview or informed consent

Inability to access a computer with Internet or inability to use a computer with Internet provided by the study as indicated by self-report

Another parent or primary caregiver of the child has been enrolled in the study (N/A for training case participants)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Open Trial

Participants receive Meaning-Centered Grief Therapy (MCGT) in two steps to refine the intervention. Step 1 involves in-person sessions, and Step 2 involves videoconferencing.

16 weeks

16 sessions (weekly, 1-hour each)

Part 2: Pilot RCT

Participants are randomized to receive either MCGT or Supportive Psychotherapy (SP) via videoconferencing to assess feasibility, acceptability, and preliminary effects.

16 weeks

16 sessions (weekly, 60-90 minutes each)

Follow-up

Participants are monitored for psychosocial outcomes and acceptability of the intervention at 3 months post-intervention.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Meaning-Centered Grief Therapy (MCGT)
• questionnaires assessments
• Supportive Psychotherapy (SP)

Trial Overview The study tests a new counseling program called Meaning-Centered Grief Therapy (MCGT) against Supportive Psychotherapy (SP). Parents will also fill out questionnaires to help researchers understand the impact of these therapies on their grief.

How Is the Trial Designed?

Group I: Meaning-Centered Grief Therapy (MCGT) Experimental Treatment 2 Interventions

Part 1: Open Trials. Participants (n = 5 for Step 1 \& n = 5 for Step 2) will receive 16 1-hour (approx) weekly sessions MCGT, \& all therapy sessions will be audio recorded. Will make every effort to complete 16 sessions in 16 weeks, due to normal life activities, this is considered an approximation (i.e. there may be weeks where sessions don't take place \&/or weeks where more than 1 session takes place in a week). If participant provides us with permission, we will also video record the sessions. Assessments will be administered at 4 time points: pre-intervention (T1), mid-intervention (T2), post-intervention (T3), \& at 3-months post-intervention (T4). They will provide their feedback about MCGT \& the measures. PI will review the open trial sessions to help refine the MCGT manual \& treatment integrity forms. Sessions for Step 1 participants in Part 1 will be held at the MSK Counseling Center. Sessions for Step 2 participants in Part 1 will be conducted via videoconferencing.

Group II: MCGT or Supportive Psychotherapy Experimental Treatment 3 Interventions

Part 2: Pilot RCT. Will randomize 66 parents to 16 weekly 60-90 minute (approx) sessions of MCGT or SP delivered via videoconferencing. Again, sessions will be audio recorded. If the participant provides us with permission, we also audio/video record the sessions. We will examine aspects of study implementation \& therapy process, including a) recruitment progress, b) implementation of the intervention, c) administration of the assessments, \& d) retention. We will also examine acceptability, defined as measures of satisfaction at T3. Psychosocial outcomes will be assessed with self-report measures at 4 time points: pre-intervention (T1), mid-intervention (T2), post-intervention (T3), \& at 3-months post-intervention (T4). Post-intervention qualitative exit interviews will assess acceptability of the intervention. Post-intervention qualitative exit interviews will assess acceptability of the MCGT intervention .

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Monash University

Collaborator

Trials

204

Recruited

10,570,000+

University of Memphis

Collaborator

Trials

73

Recruited

12,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

University of Hawaii

Collaborator

Trials

122

Recruited

55,200+

Adelphi University

Collaborator

Trials

6

Recruited

5,900+

The New School for Social Research

Collaborator

Trials

9

Recruited

3,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6401220/

An Open Trial of Meaning-Centered Grief Therapy Results: Eight of 11 (72%) enrolled parents started the MCGT intervention, and 6 of 8 (75%) participants completed all 16 sessions. Participants provided ...

2. reporter.nih.gov reporter.nih.gov/project-details/11119027

Meaning-Centered Grief Therapy for Parents Bereaved ... Primary outcomes will be reduced PG and depression symptoms. We will randomize 265 bereaved parents recruited from four institutions and the community to MCGT, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05142605

Evaluation of Grief Therapy Approaches for Bereaved ... The purpose of this study is to compare three types of support programs for parents who have lost a child. The study will see how these support programs ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-00036

Evaluation of Grief Therapy Approaches for Bereaved ... Meaning-centered grief therapy may improve several mental and physical health outcomes in parents bereaved by cancer, the leading cause of death by disease in ...

5. academic.oup.com academic.oup.com/book/25131/chapter/189405094

Meaning-Centered Grief Therapy Using mixed methods data to adapt meaning-centered psychotherapy for bereaved parents. Paper presented at the International Psycho-Oncology Society 13th ...

6. strongstartraining.org strongstartraining.org/wp-content/uploads/sites/72/2023/11/Israel-Mental-Health-Provider-Series-MCGT-Nov-2023.pdf

Meaning-Centered Grief Therapy (MCGT) 1) In addition to the deep grief they typically feel, bereaved parents often experience feelings of regret, anger, or guilt related to their ...