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Community and Familial Impacts of the Opioid Crisis

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ClinicalTrials.gov Identifier: NCT05116852
Recruitment Status : Not yet recruiting
First Posted : November 11, 2021
Last Update Posted : March 24, 2022
Sponsor:
Collaborator:
The Sandra and Arnold Gold Humanism Research Fund
Information provided by (Responsible Party):
Zev Schuman Olivier, Cambridge Health Alliance

Study Description
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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.

Condition or disease Intervention/treatment
Opioid Use Disorder Bereavement Overdose of Opiate Other: Survey

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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Community and Familial Impacts of the Opioid Crisis
Estimated Study Start Date : April 2022
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Opioid Overdose

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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.
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Other Outcome Measures:
  1. 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).

  2. 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.

  3. Anxiety [ Time Frame: Day 1 ]
    This aim will be assessed via CAT-MH's CAT-Anxiety adaptive test

  4. PTSD symptoms [ Time Frame: Day 1 ]
    This aim will be assessed via CAT-MH's CAT-PTSD adaptive test

  5. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05116852


Contacts
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Contact: Grace Janzow 716-574-6689 gjanzow@challiance.org
Contact: Alexandra Comeau 617-591-6132 acomeau@challiance.org

Locations
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United States, Massachusetts
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02141
Contact: Zev Schuman-Olivier, MD    617-591-6132    zschuman@cha.harvard.edu   
Contact: Grace Janzow    716-574-6689    gjanzow@challiance.org   
Principal Investigator: Zev Schuman-Olivier, MD         
Sponsors and Collaborators
Cambridge Health Alliance
The Sandra and Arnold Gold Humanism Research Fund
Investigators
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Principal Investigator: Zev Schuman-Olivier, MD Cambridge Health Alliance
More Information
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Responsible Party: Zev Schuman Olivier, Assistant Professor, Psychiatry, Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT05116852    
Other Study ID Numbers: CHA-IRB-20-21-7
First Posted: November 11, 2021    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Opiate Overdose
Narcotic-Related Disorders
Substance-Related Disorders
 Chemically-Induced Disorders
Mental Disorders
Drug Overdose