Clinical trial NCT05116852: Community and Familial Impacts of the Opioid Crisis
Official title: Community and Familial Impacts of the Opioid Crisis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Opioid Use Disorder
Bereavement
Overdose of Opiate
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: The Sandra and Arnold Gold Humanism Research Fund
First posted: 2021-11-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: 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.
timeFrame: Day 1
Secondary outcomes:
measure: 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.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
measure: Prolonged Grief
timeFrame: Day 1
Other outcomes:
measure: Depression
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
measure: Anxiety
timeFrame: Day 1
measure: PTSD symptoms
timeFrame: Day 1
measure: Establish the percentage of adults who have lost a loved one to opioid overdose who had worsening depression in the year after their loss.
timeFrame: Day 1
Locations:
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Zev Schuman-Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References: