Recruiting

PCT+2HOPE

Sponsor:

Yale University

Code:

NCT07115030

Conditions

Opioid Use Disorder

Intimate Partner Violence (IPV)

Post Traumatic Stress Disorder PTSD

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PCT+2HOPE

Study Details

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.

Conditions

Opioid Use Disorder

Intimate Partner Violence (IPV)

Post Traumatic Stress Disorder PTSD

Study ID

NCT07115030

Start date

Jun 1, 2026

Status verified date

Jul, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

532 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PCT+2HOPE

During the first 12 weeks, participants will be offered PCT+ via eight 1-hour group sessions facilitated by a trained counselor ("facilitator") at the treatment program where they receive MOUD. The purpose of this group is to help participants address problems in their daily lives that arise from PTSD-related impairment in psychosocial functioning. After 12 weeks, participants who meet any of the following criteria will be "stepped up" to HOPE: 1) are not retained in MOUD treatment or 2) have moderate or higher impairment in PTSD-related psychosocial functioning. Participants who are "stepped up" will be offered 10 1-hour individual sessions over the next 14 weeks. HOPE is an individual counseling program designed for women in treatment for their opioid use, who have experienced abuse from an intimate partner and are experiencing PTSD-related impairment in psychosocial functioning.

no intervention: Treatment as Usual

Participants will be provided with a list of community resources and a referral to a local domestic violence service provider that can help address experiences of relationship strain with an intimate or romantic partner.

Interventions

PCT+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.

Primary outcome measure

  • Retention in MOUD treatment [ Time Frame: Week 26 ]

Central Contacts and Locations

Central contacts

Tami Sullivan, PhD

203-789-7645tami.sullivan@yale.edu

Ashley Clayton, MA

203-789-7645 ext 121ashley.clayton@yale.edu

Locations

Liberation Programs

Recruiting

Bridgeport, Connecticut, United States, 06610

Contacts

Joanne Montgomery, LCSW, LADC

203-953-3347Joanne.Montgomery@liberationprograms.org

The APT Foundation, Inc.

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

Lynn Madden, PhD, MPA

203-781-4600lmadden@aptfoundation.org

More Information

Sponsor

Yale University

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • opioid use disorder
  • intimate partner violence
  • domestic violence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-16.