Intimate Partner Violence (IPV), Opioid Use Disorder, Post Traumatic Stress Disorder PTSD
Conditions
Keywords
opioid use disorder, intimate partner violence, domestic violence
Brief summary
Using a hybrid type 1 effectiveness-implementation approach, this study aims to evaluate the impact of a novel stepped care model ("PCT+2HOPE") versus treatment as usual (TAU) on increasing retention in community-based medication for opioid use disorder (MOUD) treatment among women who have experienced intimate partner violence (W-IPV). PCT+2HOPE includes Present-Centered Therapy (PCT+) with stepped care as indicated by moderate, severe, or extreme PTSD-related impairment in psychosocial functioning to Helping to Overcome PTSD through Empowerment (HOPE), two evidence-based behavioral interventions adapted for women with opioid use disorder (OUD). We will examine the effectiveness of PCT+2HOPE vs. TAU on the primary outcome (i.e., retention in MOUD treatment) and secondary outcomes related to trauma (i.e., PTSD-related impairment in psychosocial functioning and depression), substance use (i.e. OUD symptom severity, extra-medical opioid use \[i.e., use of prescription opioids without a doctor's prescription; in greater amounts, more often, longer than prescribed, or for a reason other than a doctor said they should be used\], and recovery), and empowerment. We will explore the extent to which the effectiveness of PCT+2HOPE vs. treatment as usual differs based on access to basic needs. We will also conduct an implementation-focused process evaluation.
Interventions
BEHAVIORALPCT+2HOPE
Each PCT+ group follows the same structure and starts with the group setting an agenda. Clients identify issues to work on using these steps: 1) Identify an issue and if/how it relates to their PTSD or substance use, 2) Brainstorm ideas that may help, 3) Evaluate how useful each idea is, and 4) Choose a plan. Clients are encouraged to implement and evaluate the effectiveness of the plan and share the outcome at their next group. At the end of the group, clients process their experiences of the discussion. HOPE is a flexible, module-based individual treatment where the ordering and emphasis of each module are determined by client priorities. HOPE is trauma-focused; clients relate their current symptoms to their experience of IPV, but do not process traumatic memories. Modules focus on 1) Establishing safety, providing information and skills that enhance empowerment, 2) Cognitive behavioral therapy skills, and 3) Improving relationships and establishing healthy boundaries.
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman; * Are ≥ 18 years old; * Receive MOUD treatment at one of the participating sites; * Have received MOUD for \>14 days to allow for initial stabilization; * Have initiated the current treatment episode within the past 12 months; * Experienced physical or psychological IPV in their lifetime; * Have at least moderate impairment in psychosocial functioning (on B-IPF) as a result of PTSD symptoms; * Available during the date/time of the intervention group * Able to read/understand English; and * Provide written informed consent.
Exclusion criteria
* Fail a capacity-to-consent questionnaire; * Have an unstable medical condition (e.g., hospitalization, planned surgery, newly starting chemotherapy, plans for palliative care) and/or unstable psychiatric illness (e.g., untreated psychosis) that would interfere with their ability to participate in study activities; * Will be unavailable for \>4 consecutive weeks during the study period (e.g., anticipated move, planned surgery); * Are unable to read/understand English; * Inability to provide at least one form of contact
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention in MOUD treatment | Week 26 | Retention in MOUD treatment at week 26. This will be measured through a combination of self-report with objective confirmation (e.g., via electronic health record, provider-confirmed treatment engagement/retention, medication bottles, urine toxicology testing). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD-related impairment in psychosocial functioning | Week 26 | The Brief-Inventory of Psychosocial Functioning (B-IPF) will be collected to assess PTSD-related impairment in functioning. The PCL-5 will be administered immediately prior and B-IPF items will be anchored to endorsed PTSD). B-IPF total scores represent an index of overall functional impairment, with higher scores indicating greater functional impairment. |
| Opioid use disorder symptom severity | Week 26 | Past 30-day opioid use disorder (OUD) symptom severity will be assessed with the Opioid Use Disorder Checklist, an 11-item assessment of DSM-5 criteria. DSM-5 considers 2 to 3 criteria mild; 4 to 5, moderate; and 6 to 11, severe OUD. |
| Days of extra-medical opioid use, past 30 days | Week 26 | Past 30-day opioid use will be assessed with the timeline follow back (TLFB) method to capture the number of days of extra-medical opioid use. |
| Urine test positive for opioid use | Week 26 | Urine toxicology testing will be performed to assess for the presence of extra-medical opioid use (e.g., opiates, oxycodone, fentanyl). |
| Depression symptom severity | Week 26 | The 9-item Patient Health Questionnaire (PHQ-9) will be collected to measure the prevalence and severity of the 9 DSM criteria for depression. The PHQ-9 uses a continuous score with higher scores indicating greater depression symptom severity and a 5-point change indicating clinically significant change. |
| Recovery | Week 26 | The Response to Addiction Recovery (R2AR) will be collected to measure recovery. The R2AR is a 19-item assessment that measures recovery from a patient-centered perspective. |
| Empowerment | Week 26 | The Personal Progress Scale-Revised (PPS-R) will be collected to measure empowerment. The PPS-R uses a continuous score with higher scores indicating higher empowerment. |
Countries
United States
Contacts
CONTACTTami Sullivan, PhD
CONTACTAshley Clayton, MA
PRINCIPAL_INVESTIGATORTami Sullivan, PhD
Yale University
PRINCIPAL_INVESTIGATORE. Jennifer Edelman, MD, MHS, AAHIVS
Yale University
PRINCIPAL_INVESTIGATORDawn Johnson, PhD
The University of Akron
Outcome results
None listed