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Community and Familial Impacts of the Opioid Crisis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05116852
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : March 22, 2023
Sponsor:
Collaborator:
The Sandra and Arnold Gold Humanism Research Fund
Information provided by (Responsible Party):
Zev Schuman Olivier, Cambridge Health Alliance

Tracking Information
First Submitted Date October 13, 2021
First Posted Date November 11, 2021
Last Update Posted Date March 22, 2023
Actual Study Start Date April 1, 2022
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 2, 2021)		 Establish the percentage of adults who have lost a loved one to opioid overdose who had increased substance use in the year after their loss. [ Time Frame: Day 1 ]
This self-report aim will be assessed via participant survey response asking for recollection of substance use before and after the loss.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 11, 2021)
  • Establish the percentage of adults who have lost a loved one to opioid overdose who received mental health treatment in the year after their loss. [ Time Frame: Day 1 ]
    This self-report aim will be assessed via participant survey response asking for recollection of mental health treatment before and after the loss.
  • Compare the level of negative impact on substance use and mental health status in the year after loss due to overdose with the impact on substance use and mental health in the year after becoming aware of a child's opioid addiction. [ Time Frame: Day 1 ]
    This aim will be assessed via participant survey response between cohorts
  • Prolonged Grief [ Time Frame: Day 1 ]
    Aa version of the prolonged grief (PG-13) scale will be used to assess presence of prolonged grief after date of loss event.
Original Secondary Outcome Measures
 (submitted: November 2, 2021)
  • Establish the percentage of adults who have lost a loved one to opioid overdose who received mental health treatment in the year after their loss. [ Time Frame: Day 1 ]
    This self-report aim will be assessed via participant survey response asking for recollection of mental health treatment before and after the loss.
  • Compare the level of negative impact on substance use and mental health status in the year after loss due to overdose with the impact on substance use and mental health in the year after becoming aware of a child's opioid addiction. [ Time Frame: Day 1 ]
    This aim will be assessed via participant survey response between cohorts
  • Prolonged Grief [ Time Frame: Day 1 ]
    We will use a version of the prolonged grief (PG-13) scale to assess presence of prolonged grief after date of loss event.
Current Other Pre-specified Outcome Measures
 (submitted: November 11, 2021)
  • Depression [ Time Frame: Day 1 ]
    This aim will be assessed via CAT-MH's CAT-DI adaptive test (computerized adaptive testing-mental health suite for depression).
  • Establish the percentage of adults who have lost a loved one to opioid overdose who had worsening eating disorders, OCD (Obsessive-compulsive disorder), or problematic sexual behaviors in the year after their loss. [ Time Frame: Day 1 ]
    This aim will be assessed via participant survey self-report responses.
  • Anxiety [ Time Frame: Day 1 ]
    This aim will be assessed via CAT-MH's CAT-Anxiety adaptive test
  • PTSD symptoms [ Time Frame: Day 1 ]
    This aim will be assessed via CAT-MH's CAT-PTSD adaptive test
  • Establish the percentage of adults who have lost a loved one to opioid overdose who had worsening depression in the year after their loss. [ Time Frame: Day 1 ]
    This self-report aim will be assessed via participant survey response asking for recollection of depression symptoms before and after the loss.
Original Other Pre-specified Outcome Measures
 (submitted: November 2, 2021)
  • Depression [ Time Frame: Day 1 ]
    This aim will be assessed via CAT-MH's CAT-DI adaptive test
  • Establish the percentage of adults who have lost a loved one to opioid overdose who had worsening eating disorders, OCD, or problematic sexual behaviors in the year after their loss. [ Time Frame: Day 1 ]
    This aim will be assessed via participant survey self-report responses.
  • Anxiety [ Time Frame: Day 1 ]
    This aim will be assessed via CAT-MH's CAT-Anxiety adaptive test
  • PTSD symptoms [ Time Frame: Day 1 ]
    This aim will be assessed via CAT-MH's CAT-PTSD adaptive test
  • Establish the percentage of adults who have lost a loved one to opioid overdose who had worsening depression in the year after their loss. [ Time Frame: Day 1 ]
    This self-report aim will be assessed via participant survey response asking for recollection of depression symptoms before and after the loss.
 
Descriptive Information
Brief Title Community and Familial Impacts of the Opioid Crisis
Official Title Community and Familial Impacts of the Opioid Crisis
Brief Summary This study aims to analyze the needs of those who have lost a loved one to opioid-related death and/or those currently supporting a loved one in treatment for Opioid Use Disorder. Mental health status related to the death or support of a loved one will be assessed through a survey and through the use of several modules of the CAT-MH (computerized adaptive testing-mental health suite) questionnaire.
Detailed Description This study aims to establish the level of needs in the community among those who have lost loved ones to opioid overdose and/or currently support those in opioid addiction recovery. This study aims to analyze the needs of those who have lost a loved one to opioid-related death and/or those currently supporting a loved one in treatment for Opioid Use Disorder. The study will evaluate the mental health status for each study participant through a primary survey as well as current participant mental health status through the use of several modules of the CAT-MH adaptive testing questionnaire. CAT-MH will be used to rapidly measure severity levels of depression, anxiety, and substance use risk after participants complete the primary survey. The primary survey assesses the immediate impact of overdose death by a loved one and recognition of the onset of opioid addiction in the years after the event on family and community members. The primary survey will compare the impact of loss and/or recovery support on mental health and substance use at specified time points before and after the loss and/or an individual finding out about a loved one's opioid addiction. The primary survey will also evaluate attitudes in this population about mindfulness and self-compassion skills training, openness to technology and various treatment options, current and past levels of depression, anxiety and grief, as well as thematic areas of need specific to those who have lost a loved one to opioid overdose and/or currently support a loved one in opioid addiction recovery.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The population will be selected by an email send both to collaborating organizations that provide peer support for those with addiction-related overdose and to healthcare systems that provide care for people with OUD to share with people in their communities who may have lost a loved one to opioid-related death.
Condition
  • Opioid Use Disorder
  • Bereavement
  • Overdose of Opiate
Intervention Other: Survey
All study participants will be asked to complete two surveys relevant to their personal experience either losing a loved one to opioid-related death, supporting a loved on in recovery for Opioid Use Disorder, or both.
Study Groups/Cohorts
  • Both grieving a loved one to opioid-related death and have an actively using loved one
    These individuals will complete the study survey for their designated experience both supporting a loved one in treatment for Opioid Use Disorder, and having lost a loved one to opioid-related death.
    Intervention: Other: Survey
  • Individuals supporting a loved one in treatment for Opioid Use Disorder
    These individuals will complete the study survey for their designated experience supporting a loved one in treatment for Opioid Use Disorder.
    Intervention: Other: Survey
  • Individuals grieving a loved one to opioid-related death
    These individuals will complete the study survey for their designated experience losing a loved one to opioid-related death.
    Intervention: Other: Survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 2, 2021)		 300
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Aged 18+, inclusive, who are competent, wish to participate and willing to provide informed consent
  • Willing and able to participate in completing the surveys using the internet on via smartphone as requested
  • Identify in one of the 3 groups: (a) Adults who have lost a direct relative or friend to opioid overdose or opioid-related death prior to taking the survey; (2) Adults who are currently supporting a loved one with active opioid addiction; (3) Adults who have lost a direct relative or friend to opioid overdose or opioid related death at least six months prior to survey participation and also currently support a loved one in active addiction recovery.

Exclusion Criteria:

  • Inability to complete the survey
  • Inability to speak, read, and understand English
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Liz Gracey 781-873-9484 egracey@challiance.org
Contact: Alexandra Comeau 617-591-6132 acomeau@challiance.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05116852
Other Study ID Numbers CHA-IRB-20-21-7
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Zev Schuman Olivier, Cambridge Health Alliance
Original Responsible Party Same as current
Current Study Sponsor Cambridge Health Alliance
Original Study Sponsor Same as current
Collaborators The Sandra and Arnold Gold Humanism Research Fund
Investigators
Principal Investigator: Zev Schuman-Olivier, MD Cambridge Health Alliance
PRS Account Cambridge Health Alliance
Verification Date March 2023