Trauma-Focused Therapies for PTSD

(HOPE Trial)

Enrolling by invitation at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Arkansas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests therapies for PTSD (posttraumatic stress disorder) to determine their effectiveness in helping individuals with opioid and stimulant use disorders engage in substance use treatment after jail release. It compares the effectiveness of starting therapy in jail versus waiting until release to encourage treatment. The trial aims to improve care for those with PTSD who also struggle with drug use, particularly after incarceration. Suitable participants have been diagnosed with probable PTSD and opioid or stimulant use problems while incarcerated. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance treatment strategies for individuals facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific situation with the trial coordinators or your healthcare provider.

What prior data suggests that these trauma-focused therapies are safe for individuals with PTSD and substance use disorders?

Research shows that both Cognitive Processing Therapy (CPT) and Written Exposure Therapy (WET) are safe treatments for PTSD.

Studies on CPT indicate it is generally easy for people to continue. One study found that only about 6.9% of participants stopped the therapy early, suggesting most people can complete it. Specifically, 82.6% of those who finished the therapy experienced major improvements in their PTSD symptoms, with none still meeting the criteria for PTSD afterward.

For WET, research shows it is also easy for most people to stick with, as less than 10% of participants dropped out. Studies have shown that WET can greatly reduce PTSD symptoms, even for those with other mental health issues or substance use problems.

Both therapies have shown promising results without any major safety concerns reported.12345

Why are researchers excited about this trial?

Researchers are excited about these trauma-focused therapies for PTSD because they offer a tailored approach for individuals in jail, which is not typically part of standard care. The intervention arm allows participants to begin Cognitive Processing Therapy (CPT) or Written Exposure Therapy (WET) while still in jail, providing continuity of care even if they're released early or return to jail. This immediate and consistent access to therapy aims to address PTSD symptoms more promptly and effectively than the usual practice, which typically involves waiting until release to begin treatment. By starting therapy in a controlled environment and maintaining it through transitions, these methods could significantly improve outcomes for people with PTSD, especially those also dealing with opioid or substance use disorders.

What evidence suggests that this trial's treatments could be effective for PTSD?

This trial will compare Cognitive Processing Therapy (CPT) and Written Exposure Therapy (WET) for PTSD. Studies have shown that both therapies can greatly reduce PTSD symptoms. Research indicates that CPT leads to major improvements in PTSD symptoms, anxiety, and depression, with these benefits lasting over time. CPT has proven effective in various settings and for diverse groups, including individuals with serious mental health issues. WET also significantly reduces PTSD symptoms and matches the effectiveness of more intensive treatments. Both therapies have demonstrated success in clinical trials, confirming their effectiveness in treating PTSD.23467

Are You a Good Fit for This Trial?

This trial is for adults (18+) in jail who screen positive for both PTSD and opioid or stimulant use disorder, can speak English, are expected to stay long enough to receive therapy and complete study assessments, and are able to give informed consent.

Inclusion Criteria

* Incarcerated at the study site
* Screened positive for probable PTSD and OUD/STUD as part of the SBIRT-J process
* Have an expected duration of incarceration that is compatible with receiving trauma-focused treatment and completing assessments within the remaining timeline of the study
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SBIRT-J Implementation

Implementation of the SBIRT-J model to identify and address substance use and mental health needs in jail

6 months
Ongoing engagement with jail stakeholders

Treatment

Participants receive PTSD therapy either in jail or upon community reentry

Variable, based on participant needs
Variable schedule to meet participant needs

Follow-up

Participants are monitored for substance use treatment initiation and retention post-release

6 months post-release

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Processing Therapy (CPT)
  • Written Exposure Therapy (WET)

Trial Overview

The study compares two ways of starting trauma-focused therapy (either right away in jail or after release) using Written Exposure Therapy or Cognitive Processing Therapy. Participants are randomly assigned to one group. The goal is to see which approach helps people start substance use treatment after leaving jail.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Arm (Jail-Initiated PTSD Therapy)Experimental Treatment2 Interventions
Group II: Control Arm (Community-Initiated PTSD Therapy)Active Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials
500
Recruited
153,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Rush University Medical Center

Collaborator

Trials
448
Recruited
247,000+

University of New Mexico

Collaborator

Trials
393
Recruited
3,526,000+

Pulaski County Regional Detention Center

Collaborator

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30332919/

A meta-analytic review of cognitive processing therapy for ...

These meta-analytic findings indicate that CPT is an effective PTSD treatment with lasting benefits across a range of outcomes.

Effectiveness of Cognitive Processing Therapy for PTSD in ...

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The CPT-TAU group maintained improvements in all outcomes from 17 to 34 weeks. Sensitivity analyses controlling for the types of traumatic ...

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Analyses included 148 patients. Large effect sizes were observed for improvements in PTSD (ΔM = 39.00), d = 2.94; anxiety (ΔM = 8.90), d = 1.79; ...

Long-Term Outcomes of Cognitive–Behavioral Treatments for ...

The ITT examination of diagnostics indicated that 22.2% of CPT and 17.5% of PE participants met the diagnosis for PTSD according to the Clinician-Administered ...

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This study will evaluate the effectiveness of cognitive processing therapy versus prolonged exposure therapy in treating women with post-traumatic stress ...