Community and Familial Impacts of the Opioid Crisis

Sponsor
Cambridge Health Alliance (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05116852
Collaborator
The Sandra and Arnold Gold Humanism Research Fund (Other)
300
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2
149.7

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Community and Familial Impacts of the Opioid Crisis
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm 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

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. [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. [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. [Day 1]

    This aim will be assessed via participant survey response between cohorts

  3. Prolonged Grief [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 [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. [Day 1]

    This aim will be assessed via participant survey self-report responses.

  3. Anxiety [Day 1]

    This aim will be assessed via CAT-MH's CAT-Anxiety adaptive test

  4. PTSD symptoms [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. [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Cambridge Health Alliance Cambridge Massachusetts United States 02141

Sponsors and Collaborators

  • Cambridge Health Alliance
  • The Sandra and Arnold Gold Humanism Research Fund

Investigators

  • Principal Investigator: Zev Schuman-Olivier, MD, Cambridge Health Alliance

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Nov 11, 2021
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2022