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Behavioral Intervention
Cognitive Emotion Regulation Training for Grief
N/A
Recruiting
Led By Bryan Denny, Ph.D.
Research Sponsored by Bryan Denny
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, final training session (approximately 2 weeks post-baseline), and at 1 and 2 months post-intervention
Awards & highlights
Study Summary
This trialstudies how thinking objectively about a negative situation can reduce psychological distress in bereaved spouses.
Who is the study for?
This trial is for English-speaking adults who have recently lost a spouse and are experiencing intense grief. They must score at least 25 on the Inventory for Complicated Grief, be able to undergo MRI scans safely, and have faced the loss within the last 5-7 months.Check my eligibility
What is being tested?
The study tests how changing one's thoughts about emotional events (reappraisal) can help manage stress, heart rate variability, inflammation levels in blood, and brain activity. It compares two types of reappraisal: distancing (objective view) versus reinterpretation (imagining better outcomes).See study design
What are the potential side effects?
There may not be direct side effects from cognitive training itself; however, participants might experience discomfort or emotional distress when discussing their grief or undergoing MRI scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, final training session (approximately 2 weeks post-baseline), and at 1 and 2 months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, final training session (approximately 2 weeks post-baseline), and at 1 and 2 months post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in depressive symptoms
Change in grief rumination
Change in neural activity
+3 moreSecondary outcome measures
Frequency of reappraisal usage
Inflammatory biomarkers
Physical health
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DistancingExperimental Treatment1 Intervention
Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction in which detailed instructions for implementation of the distancing strategy is explained (i.e. appraising an emotional stimulus as an objective, impartial observer).
Group II: ReinterpretationActive Control1 Intervention
Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction in which detailed instructions for implementation of the reinterpretation strategy is explained (i.e. imagining a better outcome than what initially seemed apparent).
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Who is running the clinical trial?
Bryan DennyLead Sponsor
1 Previous Clinical Trials
270 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,684 Previous Clinical Trials
28,025,973 Total Patients Enrolled
Bryan Denny, Ph.D.Principal InvestigatorWilliam Marsh Rice University
1 Previous Clinical Trials
270 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to score at least 25 on a test called the Inventory for Complicated Grief.I am 18 years old or older.I am currently undergoing psychotherapy.I have been diagnosed with a lung, heart, liver, or kidney disease, or diabetes.I have major issues with my vision, hearing, or thinking.You have lost your romantic partner within the last 5-7 months.You are physically able to undergo an MRI scan without any safety concerns.
Research Study Groups:
This trial has the following groups:- Group 1: Reinterpretation
- Group 2: Distancing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Grief Patient Testimony for trial: Trial Name: NCT04822194 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the overall participant count for this clinical research?
"Affirmative. The information found on clinicaltrials.gov verifies that this research trial is actively looking for participants. It was initially posted on February 2nd 2022 and has had its last update October 25th 2022; the study seeks to enroll 84 people at a single site."
Answered by AI
Is enrollment open for this clinical experiment right now?
"Affirmative. Clinicaltrials.gov presents data that this trial, first published on February 2nd 2022, is now actively seeking participants. There are 84 patients to recruit from one single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Kansas
What site did they apply to?
Rice University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
Needing help with grief from losing my son to suicide.
PatientReceived 1 prior treatment
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