Community and Familial Impacts of the Opioid Crisis

Active, not recruiting

• Conditions: Opioid Use Disorder; Bereavement; Overdose of Opiate
• Interventions: Other: Survey

• Registration Number: NCT05116852
• Lead Sponsor: Cambridge Health Alliance

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 Timeline

• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-11
• Study Start: 2022-04-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2024-04-21
• Study Completion: 2024-06-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Both grieving a loved one to opioid-related death and have an actively using loved one	Survey	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.
Individuals supporting a loved one in treatment for Opioid Use Disorder	Survey	These individuals will complete the study survey for their designated experience supporting a loved one in treatment for Opioid Use Disorder.
Individuals grieving a loved one to opioid-related death	Survey	These individuals will complete the study survey for their designated experience losing a loved one to opioid-related death.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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.

Trial Locations

Locations (1)

Cambridge Health Alliance; 🇺🇸 Cambridge, Massachusetts, United States