Opioid Use Disorder Clinical Trial
Official title:
Community and Familial Impacts of the Opioid Crisis
Verified date | April 2024 |
Source | Cambridge Health Alliance |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cambridge Health Alliance | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Cambridge Health Alliance | The Sandra and Arnold Gold Humanism Research Fund |
United States,
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 |
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