Grief Therapy Approaches for Bereaved Parents

Recruiting at 3 trial locations

Overseen By Wendy G. Lichtenthal, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Psychiatric disturbance, No internet, Prisoners, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

415 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different support programs for parents who have lost a child to cancer, focusing on how these programs affect grief and depression. Participants will join one of three groups: Meaning-Centered Grief Therapy, Supportive Counseling, or Enhanced Usual Care. The trial suits parents who lost a child to cancer at least six months ago and continue to experience grief. As an unphased trial, it offers a unique opportunity for parents to find support and potentially improve their emotional well-being.

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 support programs for grief, so it's unlikely that medication changes are required, but please check with the study team to be sure.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Meaning-Centered Grief Therapy (MCGT) is generally easy for participants to handle. One study found that 75% of participants attended all sessions, indicating it is manageable for most people. No reports of serious side effects emerged, suggesting it is safe for participants.

Supportive Counseling is a well-researched and commonly used method in grief therapy. Although specific safety details are not provided, it is a standard therapy and is generally considered safe. It often helps those experiencing intense grief, and no major safety issues have been noted.

Both therapies aim to support parents coping with the deep sorrow of losing a child. Overall, the treatments seem safe and could be helpful for those seeking support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these grief therapy approaches for bereaved parents because they offer tailored support that goes beyond typical bereavement counseling. Meaning-Centered Grief Therapy (MCGT) focuses on helping parents find meaning and purpose after loss, which could lead to more profound and lasting emotional healing. Supportive Counseling provides a flexible framework that adapts to individual needs, offering a personalized touch that standard grief therapy might lack. Enhanced usual care ensures participants have continuous support, potentially making it more comprehensive than existing options. These approaches aim to address the unique challenges faced by bereaved parents in a more targeted and effective way.

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

Research has shown that Meaning-Centered Grief Therapy (MCGT), which participants in this trial may receive, can assist parents who have lost a child by helping them find meaning or purpose in their lives afterward. Studies have found that this therapy is practical and well-received, with parents experiencing less grief and depression. Supportive Counseling, another treatment option in this trial, focuses on providing emotional support and understanding, which can help ease feelings of loss and sadness. Both treatments aim to help parents cope with their grief in different but effective ways. ^{1 2 6 7 8}

Who Is on the Research Team?

Wendy Lichtenthal, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for parents in the U.S. who have lost a child to cancer and are experiencing intense grief (with specific grief scores of 30 or above). Participants must be over 18, speak English, and it's been at least 6 months since their loss. They should live in states where the study can legally operate via telepsychology.

Inclusion Criteria

Elevated prolonged grief (PG) symptoms (PG-13-R scores of 30 or above)

Biological, adoptive, step-parent, or legal guardian from across the United States who lost a child diagnosed with cancer

Experienced the loss of a child diagnosed with cancer at least 6 months prior to enrollment

Exclusion Criteria

Significant psychiatric disturbance precluding completion of assessment measures, interview, or informed consent

I cannot use a device for video calls and do not want to use one provided by the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three support programs: Meaning-Centered Grief Therapy, Supportive Counseling, or Enhanced Usual Care for approximately 4 months or longer as needed

16 weeks

Follow-up

Participants are monitored for changes in grief and depression symptoms using various scales

10 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced usual care
• Meaning-Centered Grief Therapy
• Supportive Counseling

Trial Overview The study compares three support programs for bereaved parents: Meaning-Centered Grief Therapy, Supportive Counseling, and Enhanced Usual Care. It aims to see how these approaches help with grief and depression symptoms after losing a child to cancer.

How Is the Trial Designed?

Group I: Cohort 1: Meaning-Centered Grief Therapy (MCGT) Experimental Treatment 1 Intervention

Participants will receive the MCGT intervention for approximately 4 months or longer as needed.

Group II: Group 2: Supportive Psychotherapy (SP) Active Control 1 Intervention

Participants will receive the SP intervention for approximately 4 months or longer as needed.

Group III: Group 3: Enhanced usual care (EUC) Active Control 1 Intervention

Participants will receive EUC for approximately 4 months or longer as needed.

Enhanced usual care is already approved in United States for the following indications:

Approved in United States as Podimetrics SmartMat for:

• Prevention of diabetic foot ulcers

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

This study is testing a new internet-based cognitive-behavioral therapy (iCBT) called GROw for prolonged grief disorder (PGD) in a randomized trial with 48 adults, comparing it to traditional face-to-face therapy.

The research aims to assess not only the feasibility of the GROw program in terms of participant adherence and satisfaction but also its potential effectiveness in reducing grief and improving mental health outcomes over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial. Tur, C., Campos, D., Herrero, R., et al.[2023]

Meaning Centered Group Psychotherapy (MCGP) significantly improved spiritual well-being and a sense of meaning in patients with advanced cancer (N=90) over an 8-week period, with benefits continuing to increase even two months after the intervention.

In contrast, patients in the supportive group psychotherapy (SGP) showed no significant improvements in spiritual well-being, anxiety, or desire for death, highlighting the unique efficacy of MCGP in addressing emotional and spiritual suffering at the end of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-centered group psychotherapy for patients with advanced cancer: a pilot randomized controlled trial. Breitbart, W., Rosenfeld, B., Gibson, C., et al.[2022]

A study comparing telephone (330 participants) and in-person (115 participants) semistructured intake assessments for grief intervention found that telephone assessments yielded lower composite scores, particularly in assessing the risk of complications.

Despite the lower scores in telephone assessments, the structured grief symptom assessment results were similar, suggesting that e-health assessments can be effective for evaluating grief symptoms, but may require careful consideration for risk assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone versus in-person intake assessment for bereavement intervention: Does efficiency come at a cost? Newsom, C., Schut, H., Stroebe, M., et al.[2019]

Meaning-Centered Grief Therapy (MCGT) was found to be feasible and acceptable for parents grieving the loss of a child to cancer, with 75% of participants completing all 16 sessions and providing positive feedback.

Participants showed significant improvements in prolonged grief, sense of meaning, depression, and overall psychological well-being, with most gains maintained or increased at a three-month follow-up, indicating MCGT's potential effectiveness as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open trial of meaning-centered grief therapy: Rationale and preliminary evaluation. Lichtenthal, WG., Catarozoli, C., Masterson, M., et al.[2023]

The study assessed the feasibility of a meaning-based group counseling (MBGC) intervention for individuals experiencing uncomplicated bereavement, involving 26 participants who were randomly assigned to either the MBGC or a control group.

Out of the participants, 20 completed the study, indicating that an RCT design is practical for evaluating MBGC, which could lead to more effective support for those grieving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reconstructing Meaning with Others in Loss: A Feasibility Pilot Randomized Controlled Trial of a Bereavement Group. MacKinnon, CJ., Smith, NG., Henry, M., et al.[2015]

The study involved 78 women who experienced stillbirth or early perinatal death, with assessments conducted 6 months post-delivery, showing no overall difference in grief scores between the grief support team and control groups.

However, the treatment group reported significantly lower levels of anger-hostility and physical symptoms related to grief, particularly benefiting those with low social support, indicating that targeted grief support can help alleviate specific grief symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a perinatal grief support team. Lake, MF., Johnson, TM., Murphy, J., et al.[2019]

A study involving 51 cancer inpatients found that a Meaning-Centered Psychotherapy Model tailored for palliative care, especially with compassion elements, is feasible and acceptable for patients in their final weeks of life.

Patients reported that key elements like meaning, self-compassion, and legacy were particularly helpful, suggesting that these constructs can aid in coping with the dying process, although further research with larger samples is needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-centered psychotherapy integrated with elements of compassion: A pilot study to assess feasibility and utility. Gil, F., Fraguell, C., Benito, L., et al.[2019]

Online therapeutic writing courses can provide bereaved parents with a valuable opportunity for self-exploration and emotional processing after the unexpected death of a child, fostering a sense of belonging and validation within a supportive community.

While these online interventions show promise in helping parents cope with their grief, they should complement, not replace, traditional therapies like psychotherapy, suggesting a need for further research into integrating different models of grief support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Norwegian Mothers Attending an Online Course of Therapeutic Writing Following the Unexpected Death of a Child. Lehmann, OV., Neimeyer, RA., Thimm, J., et al.[2023]

A new inpatient grief therapy program called Cross-Modality Grief Therapy (CMGT) was evaluated over a 3-month period in a Dutch Health Care Centre, showing systematic advantages in reducing symptoms compared to a traditional therapy program.

The effectiveness of CMGT was assessed using the General Health Questionnaire at multiple time points, indicating that the integrated approach of behavior and art therapy contributed to its success in treating grief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-modality grief therapy: description and assessment of a new program. Schut, HA., de Keijser, J., van den Bout, J., et al.[2006]

In a study of 156 bereaved parents, 45% struggled to make sense of their loss, and 21% could not identify any benefits from their experience, which correlated with more severe grief symptoms.

The research identified 32 distinct ways parents sought meaning in their child's death, highlighting the significance of spirituality and a desire to help others, suggesting that meaning-centered grief interventions could be beneficial for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sense and significance: a mixed methods examination of meaning making after the loss of one's child. Lichtenthal, WG., Currier, JM., Neimeyer, RA., et al.[2021]

The study will compare two internet-based interventions (IBIs) for grief, LIVIA 1 and LIVIA 2.0, with the aim of determining if LIVIA 2.0, which includes a 'guidance on demand' feature, is more effective and has lower dropout rates than LIVIA 1.

A total of 234 participants will be recruited to assess changes in grief symptoms, depressive symptoms, and overall well-being over a 24-week period, highlighting the importance of innovative IBIs in addressing increased grief symptoms following the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting People Who Have Lost a Close Person by Bereavement or Separation: Protocol of a Randomized Controlled Trial Comparing Two French-Language Internet-Based Interventions. Debrot, A., Kheyar, M., Efinger, L., et al.[2022]

A modified meaning-centered psychotherapy (MCP) was successfully adapted for Japanese bereaved families, with all five participants completing the 5-session program, indicating good feasibility and acceptance of the intervention.

Participants showed significant improvements in grief and depression symptoms, suggesting that the MCP helped them reappraise their experiences and rediscover meaning in life after loss, which may facilitate post-traumatic growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience of application of the meaning-centered psychotherapy to Japanese bereaved family of patients with cancer - A mixed-method study. Koda, R., Fujisawa, D., Kawaguchi, M., et al.[2023]

Citations

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

An Open Trial of Meaning-Centered Grief Therapy To determine the preliminary feasibility, acceptability, and effects of Meaning-Centered Grief Therapy (MCGT) for parents who lost a child to cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4361184/

Implications for the Development of Meaning-Centered Grief ... This review describes research on meaning and meaning-making in parents who lost a child to cancer, suggesting the need for a meaning-centered therapeutic ...

3. 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05142605

Evaluation of Grief Therapy Approaches for Bereaved ... Meaning-Centered Grief Therapy is a therapy that focuses on helping participants find a sense of meaning or purpose in participants' life after participants' ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666560324000306

Culturally sensitive grief treatment and support: A scoping ... The goal of this scoping review was to assess the scope and nature of evidence concerning culturally sensitive grief treatment and support interventions.

6. umiamihealth.org umiamihealth.org/en/sylvester-comprehensive-cancer-center/research/labs/lichtenthal-lab/research

Research | University of Miami Health ... The goal of this study is to adapt Meaning-Centered Grief Therapy (MCGT) for parents bereaved by suicide using stakeholder feedback and to then pilot MCGT for ...

7. 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 ...

8. 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 ...