Skip to main content
OpenTrials
Completed

NCT Number: NCT05116852

Community and Familial Impacts of the Opioid Crisis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid Use Disorder Bereavement Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Narcotic-Related Disorders Opiate Overdose Opioid-Related Disorders Overdose of Opiate Prescription Drug Misuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cambridge Health Alliance

Cambridge, Massachusetts, 02141, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Other

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cambridge Health Alliance

Other

Collaborators

  • The Sandra and Arnold Gold Humanism Research Fund

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 11, 2021
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.