Community and Familial Impacts of the Opioid Crisis

Opioid Use Disorder Clinical Trial

Official title:

Community and Familial Impacts of the Opioid Crisis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05116852
• Other study ID #: CHA-IRB-20-21-7
• Status: Active, not recruiting
• Start date: April 1, 2022
• Est. completion date: June 21, 2024

Study information

• Verified date: April 2024
• Source: Cambridge Health Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 21, 2024
• Est. primary completion date: April 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bereavement
• Opiate Overdose
• Opioid Use Disorder
• Opioid-Related Disorders
• 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.

Locations

Country	Name	City	State
United States	Cambridge Health Alliance	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge Health Alliance	The Sandra and Arnold Gold Humanism Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression	This aim will be assessed via CAT-MH's CAT-DI adaptive test (computerized adaptive testing-mental health suite for depression).	Day 1
Other	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.	This aim will be assessed via participant survey self-report responses.	Day 1
Other	Anxiety	This aim will be assessed via CAT-MH's CAT-Anxiety adaptive test	Day 1
Other	PTSD symptoms	This aim will be assessed via CAT-MH's CAT-PTSD adaptive test	Day 1
Other	Establish the percentage of adults who have lost a loved one to opioid overdose who had worsening depression in the year after their loss.	This self-report aim will be assessed via participant survey response asking for recollection of depression symptoms before and after the loss.	Day 1
Primary	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.	This self-report aim will be assessed via participant survey response asking for recollection of substance use before and after the loss.	Day 1
Secondary	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.	This self-report aim will be assessed via participant survey response asking for recollection of mental health treatment before and after the loss.	Day 1
Secondary	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.	This aim will be assessed via participant survey response between cohorts	Day 1
Secondary	Prolonged Grief	Aa version of the prolonged grief (PG-13) scale will be used to assess presence of prolonged grief after date of loss event.	Day 1