GriefNCT05142605
Evaluation of Grief Therapy Approaches for Bereaved Parents
A study testing Meaning-Centered Grief Therapy and Supportive Psychotherapy in people with Grief and Bereavement, run by University of Miami at 5 sites in United States.
Trial summary
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 affect participants' grief and depression symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grief, Bereavement, Cancer
- What is being tested?
- Meaning-Centered Grief Therapy and Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Mar 2022to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Parent Participant Inclusion Criteria:
- A biological, adoptive, step-parent or legal guardian from across the United States who lost a child diagnosed with cancer as indicated by self-report
- Age 18 or older as indicated by self-report
- Experienced the loss of a child diagnosed with cancer at least 6 months prior to enrollment as indicated by medical record or self-report
- Elevated prolonged grief (PG) symptoms (PG-13-R scores of 30 or above)
- Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
- English-speaking as per the language assessment items below and willing to receive the intervention in English
- What is the participant's preferred language? °(Specify Lang)___________________________
- How well does the participant speak English?
- Very well (PARTICIPANT IS ELIGIBLE)
- Well (PARTICIPANT is NOT ELIGIBLE)
- Not well (PARTICIPANT is NOT ELIGIBLE)
- Not at all (PARTICIPANT is NOT ELIGIBLE)
- Individuals who are pregnant per self-report are eligible to participate
Support Provider Inclusion Criteria:
- Must be age 18 or over as indicated by self-report
- Has been identified by the bereaved parent participant as a support or someone important to bereaved parent
- Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
- English-speaking as per the language assessment items below and willing to receive the intervention in English
- What is the participant's preferred language? °(Specify Lang)___________________________
- How well does the participant speak English?
- Very well (PARTICIPANT IS ELIGIBLE)
- Well (PARTICIPANT is NOT ELIGIBLE)
- Not well (PARTICIPANT is NOT ELIGIBLE)
- Not at all (PARTICIPANT is NOT ELIGIBLE)
- Individuals who are pregnant per self-report are eligible to participate.
Family Participant Inclusion Criteria:
- A biological, adoptive, step-parent or legal guardian from across the United States who lost a child diagnosed with cancer as indicated by self-report
- Age 18 or older as indicated by self-report
- Experienced the loss of a child diagnosed with cancer at least 6 months prior to enrollment as indicated by medical record or self-report
- Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
- English-speaking as per the language assessment items below and willing to receive the intervention in English
- What is the participant's preferred language? °(Specify Lang)___________________________
- How well does the participant speak English?
- Very well (PARTICIPANT IS ELIGIBLE)
- Well (PARTICIPANT is NOT ELIGIBLE)
- Not well (PARTICIPANT is NOT ELIGIBLE)
- Not at all (PARTICIPANT is NOT ELIGIBLE)
- Individuals who are pregnant per self-report are eligible to participate.
Training Case Inclusion Criteria:
- A biological, adoptive, step-parent, or legal guardian from across the United States as indicated by self-report
- Age 18 or older as indicated by self-report
- Experienced the loss of a child at least 6 months prior to enrollment as indicated by medical record or self-report
- Score of 29 or below on the PG-13-R OR lost a child to a cause other than cancer OR child's additional guardian has consented as a Parent Participant and has not provided permission to share participation status OR past participants who indicate an interest in serving as a training case and, in the judgment of the Principal Investigator, would be appropriate to enroll as a training case
- Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
- English-speaking as per the language assessment items below and willing to receive the intervention in English
- What is the participant's preferred language? ° (Specify Lang)___________________________
- How well does the participant speak English?
- Very well (PARTICIPANT IS ELIGIBLE)
- Well (PARTICIPANT is NOT ELIGIBLE)
- Not well (PARTICIPANT is NOT ELIGIBLE)
- Not at all (PARTICIPANT is NOT ELIGIBLE)
- Individuals who are pregnant per self-report are eligible to participate.
Training Case Support Provider Inclusion Criteria:
- Must be age 18 or over as indicated by self-report
- Has been identified by the bereaved parent training case participant as a support or someone important to bereaved parent
- Resides in a state in which a study clinical supervisor is licensed to permit telepsychology practice or otherwise able to comply with current telehealth regulations as indicated by self-report
- English-speaking as per the language assessment items below and willing to receive the intervention in English
- What is the participant's preferred language? ° (Specify Lang)___________________________
- How well does the participant speak English?
- Very well (PARTICIPANT IS ELIGIBLE)
- Well (PARTICIPANT is NOT ELIGIBLE)
- Not well (PARTICIPANT is NOT ELIGIBLE)
- Not at all (PARTICIPANT is NOT ELIGIBLE)
- Individuals who are pregnant per self-report are eligible to participate.
Parent Participant Exclusion Criteria:
- Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude completion of the assessment measures, interview or informed consent
- Inability to access a functional device for videoconferencing and declines offer to use a study loaner device as indicated by self-report
- Prisoners
- Participants unable to consent
Support Provider Exclusion Criteria:
- Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude informed consent
- Inability to access a computer with Internet as indicated by self-report
- Prisoners
- Participants unable to consent
Family Participant Exclusion Criteria:
- Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude informed consent
- Inability to access a computer with Internet as indicated by self-report
- Prisoners
- Participants unable to consent
Training Case Exclusion Criteria:
- Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude completion of the assessment measures, interview or informed consent
- Inability to access a functional device for videoconferencing and declines offer to use a study loaner device as indicated by self-report
- Prisoners
- Participants unable to consent
Training Case Support Provider Exclusion Criteria
- Significant psychiatric disturbance sufficient, in the investigator/study staff's judgment, to preclude informed consent
- Inability to access a computer with Internet as indicated by self-report
- Prisoners
- Participants unable to consent
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
St Jude's Children's Hospital (Data collection only)
Memphis, Tennessee, 38105
Erica Kaye, MD, 901-595-8188, erica.kaye@stjude.org
Erica Kaye
- Not yet recruiting
University of Miami
Miami, Florida, 33136
Wendy Lichtenthal, 305-243-8983, wendy.lichtenthal@miami.edu
Wendy Lichtenthal, PhD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Talia Zaider, PhD, 646-888-0162
Talia Zaider, PhD
- Recruiting
Children's Hospital of Philadelphia (Data Collection Only)
Philadelphia, Pennsylvania, 19104
Lamia Barakat, PhD, (267) 426-0762
Lamia Barakat, PhD
- Recruiting
Stanford University (Data Collection Only)
Stanford, California, 94305
Justin Baker, MD, 650-725-4187, jusbaker@stanford.edu
About this study
Official title: Meaning-Centered Grief Therapy for Parents Bereaved by Cancer: A Multisite Randomized Controlled Trial
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 affect participants' grief and depression symptoms. The three support programs are called Meaning-Centered Grief Therapy, Supportive Counseling, and Enhanced Usual Care.
- Conditions
- Grief, Bereavement, Cancer
- Being tested
- Meaning-Centered Grief Therapy, Supportive Psychotherapy, Enhanced Usual Care
- Keywords
- Parental bereavement, Parents, Elevated prolonged grief symptoms
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meaning-Centered Grief TherapyBehavioural
Also called MCGT
Meaning-Centered Grief Therapy is a therapy that focuses on helping participants find a sense of meaning or purpose in participants' life after participants' loss. Parents will be provided (via mail or email) a workbook. This support program will involve 16 sessions that will take place about once a week. Each session will last 60 to 90 minutes and will be delivered through videoconferencing.
Supportive PsychotherapyBehavioural
Also called SP
Supportive Psychotherapy will help participants cope with participants' loss by giving them a place to express participants' feelings and providing participants with support during the sessions. Supportive counseling will involve 16 sessions that will take place about once a week. Each session will last 60 to 90 minutes and will be delivered through videoconferencing.
Enhanced Usual CareBehavioural
Also called EUC
Enhanced usual care includes any support or resources participants may receive as part of participants' standard care (for example, therapy sessions with a local therapist), enhanced with additional resources.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Meaning-Centered Grief Therapy (MCGT) | Experimental | Participants will receive the MCGT intervention for approximately 4 months or longer as needed. Receives: Behavioral: Meaning-Centered Grief Therapy |
| Group 2: Supportive Psychotherapy (SP) | Active comparator | Participants will receive the SP intervention for approximately 4 months or longer as needed. Receives: Behavioral: Supportive Psychotherapy |
| Group 3: Enhanced usual care (EUC) | Active comparator | Participants will receive EUC for approximately 4 months or longer as needed. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prolonged Grief Disorder-13-R (PG-13-R) scores
The Prolonged Grief-13-Revised (PG-13-R) is a 13-item self-report scale evaluating the proposed symptoms of prolonged grief disorder. The PG-13-R assesses the severity of 10 grief-related symptoms using a 5-point Likert-type scale. Additional items evaluate the experience of a significant loss, symptom duration, and functional impairment. The PG-13-R yields a score between 10 and 50, where a higher score indicates that a person experiences higher levels of prolonged grief.
Measured: Baseline up to 10 months
Change in Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) score
The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) is a 20-item self-report measure assessing the frequency of depressive symptoms in the past week on a 4-point scale. Total scores range from 0 to 60, with scores above 16 indicating possible clinically significant depression levels.
Measured: Baseline up to 10 months
Secondary outcomes (7)
Change in PROMIS: Global Health Scale (PROMIS-GH) scores
The PROMIS-Global Health Scale (PROMIS-GH), is a National Institutes of Health-developed and well-validated self-report assessment that captures global mental health (i.e., quality of life, mental health, satisfaction with social activities, and emotional problems) and physical health (i.e., physical health, physical function, pain, and fatigue). PROMIS-GH consists of 10-items, with each utilizing a 7-day recall period. The initial 9-items make use of a 5-point scale, with 3 separate verbal anchors that ask patients to rate their health or abilities, indicate how often they are experiencing a phenomenon or how severe their symptomatic experience is. A final item asks patients to indicate their average pain on a 0-10 numeric rating scale (i.e., 0 = no pain, 10 = worst pain imaginable). The composite score is a sum of each item, and scores range from 10 to 50.
Measured: Baseline up to 10 months
Change in State-Trait Anxiety Inventory - Short Form (STAI-SF) scores
The State-Trait Anxiety Inventory (STAI-SF) is a 10-item valid and reliable self-report measure of both state and trait anxiety. For both of these subscales, higher scores indicate higher levels of anxiety. Responses range from 1 (almost never) to 4 (almost always), with higher scores reflecting increased anxiety.
Measured: Baseline up to 10 months
Change in Beck Hopelessness Scale - Short Form (BHS-SF) scores
The Beck Hopelessness Scale-Short Form (BHS-SF) is a 4-item true-false self-report measure of participants' degree of pessimism and hopelessness. Scores range from 0 to 12. A higher score indicates more experiences of pessimism or lack of hope.
Measured: Baseline up to 10 months
Change in Presence of Regret Scale scores
The presence of regret and associated distress will be assessed by items used in the investigative team's prior research on regret. The measure asks respondents to rate level of distress associated with regret on a scale from 1-10 with higher scores indicating greater distress.
Measured: Baseline up to 10 months
Change in Posttraumatic Growth Inventory - Short Form (PTGI-SF) scores
The Posttraumatic Growth Inventory-Short Form (PTGI-SF) is a 10-item self-report measure that assesses positive outcomes following stressful life events. Scores range from 0 to 50, and higher total scores reflect higher levels of posttraumatic growth.
Measured: Baseline up to 10 months
Change in Continuing Bonds Scale (CBS) scores
The Continuing Bonds Scale (CBS) is an 11-item self-report measure that assesses the degree of continued connection with a deceased loved one on a 5-point scale. Scores range from 11 to 55, with higher scores reflecting a stronger continued bond.
Measured: Baseline up to 10 months
Change in Prolonged Grief Disorder - Clinical Global Impressions Scale - Severity and Improvement Items (PGD-CGI) ratings
The Prolonged Grief Disorder-Clinical Global Impression Scale (PGD-CGI), adapted from trials examining Complicated Grief Treatment, will be used to assess global severity and symptom improvement. It is a two-item observer assessment that uses a seven-point scale for a global rating of illness severity and improvement. Scores range from 1 to 7, with lower scores indicating low severity of symptoms and improvement in functioning.
Measured: Baseline up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start31 Mar 2022
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GriefStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 415 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Wendy G. Lichtenthal, University of Miami
- Investigators
- Wendy G. Lichtenthal, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142605
- Sponsor's protocol ID
- 20230899
- Other IDs
- R01NR019637
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2021
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meaning-Centered Grief Therapy for Parents Bereaved by Cancer: A Multisite Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05142605
- Acronym / sponsor ID
- 20230899
- Conditions
- Grief, Bereavement, Cancer
- Keywords
- Parental bereavement, Parents, Elevated prolonged grief symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 415 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 2 Dec 2021 (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.
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 affect participants' grief and depression symptoms. The three support programs are called Meaning-Centered Grief Therapy, Supportive Counseling, and Enhanced Usual Care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Meaning-Centered Grief Therapy (MCGT) | Experimental | Behavioral: Meaning-Centered Grief TherapyParticipants will receive the MCGT intervention for approximately 4 months or longer as needed. |
| Group 2: Supportive Psychotherapy (SP) | Active comparator | Behavioral: Supportive PsychotherapyParticipants will receive the SP intervention for approximately 4 months or longer as needed. |
| Group 3: Enhanced usual care (EUC) | Active comparator | Behavioral: Enhanced Usual CareParticipants will receive EUC for approximately 4 months or longer as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Meaning-Centered Grief TherapyAlso: MCGTMeaning-Centered Grief Therapy is a therapy that focuses on helping participants find a sense of meaning or purpose in participants' life after participants' loss. Parents will be provided (via mail or email) a workbook. This support program will involve 16 sessions that will take place about once a week. Each session will last 60 to 90 minutes and will be delivered through videoconferencing. | Behavioural | Cohort 1: Meaning-Centered Grief Therapy (MCGT) |
| Supportive PsychotherapyAlso: SPSupportive Psychotherapy will help participants cope with participants' loss by giving them a place to express participants' feelings and providing participants with support during the sessions. Supportive counseling will involve 16 sessions that will take place about once a week. Each session will last 60 to 90 minutes and will be delivered through videoconferencing. | Behavioural | Group 2: Supportive Psychotherapy (SP) |
| Enhanced Usual CareAlso: EUCEnhanced usual care includes any support or resources participants may receive as part of participants' standard care (for example, therapy sessions with a local therapist), enhanced with additional resources. | Behavioural | Group 3: Enhanced usual care (EUC) |
Primary outcome
Change in Prolonged Grief Disorder-13-R (PG-13-R) scores
Time frame: Baseline up to 10 months
The Prolonged Grief-13-Revised (PG-13-R) is a 13-item self-report scale evaluating the proposed symptoms of prolonged grief disorder. The PG-13-R assesses the severity of 10 grief-related symptoms using a 5-point Likert-type scale. Additional items evaluate the experience of a significant loss, symptom duration, and functional impairment. The PG-13-R yields a score between 10 and 50, where a higher score indicates that a person experiences higher levels of prolonged grief.
Change in Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) score
Time frame: Baseline up to 10 months
The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) is a 20-item self-report measure assessing the frequency of depressive symptoms in the past week on a 4-point scale. Total scores range from 0 to 60, with scores above 16 indicating possible clinically significant depression levels.
7 secondary outcomes
Change in PROMIS: Global Health Scale (PROMIS-GH) scores
Time frame: Baseline up to 10 months
Change in State-Trait Anxiety Inventory - Short Form (STAI-SF) scores
Time frame: Baseline up to 10 months
Change in Beck Hopelessness Scale - Short Form (BHS-SF) scores
Time frame: Baseline up to 10 months
Change in Presence of Regret Scale scores
Time frame: Baseline up to 10 months
Change in Posttraumatic Growth Inventory - Short Form (PTGI-SF) scores
Time frame: Baseline up to 10 months
Change in Continuing Bonds Scale (CBS) scores
Time frame: Baseline up to 10 months
Change in Prolonged Grief Disorder - Clinical Global Impressions Scale - Severity and Improvement Items (PGD-CGI) ratings
Time frame: Baseline up to 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Wendy G. Lichtenthal, PhD principal investigator
University of Miami
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meaning-Centered Grief Therapy and Supportive Psychotherapy in people with Grief and Bereavement, run by University of Miami at 5 sites 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?
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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy G. Lichtenthal, PhD (305-243-8983, wendy.lichtenthal@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prolonged Grief Disorder-13-R (PG-13-R) scores (time frame: Baseline up to 10 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 1 Jul 2026.