Cognitive Processing Therapy for PTSD and Opioid Use Disorder

(OPTIMO Trial)

Overseen By Aaron D Fox, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The City College of New York

Must be taking: Opioid use disorder meds

Disqualifiers: Suicidal risk, Psychotic, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a modified version of Cognitive Processing Therapy (CPT) can reduce PTSD symptoms in adults who use syringe services programs and receive treatment for opioid use disorder. It evaluates the effectiveness of delivering the therapy via telehealth and assesses participants' adherence to their opioid use medication. This trial suits individuals who frequently visit syringe services programs, have a PTSD diagnosis, and currently take medication like buprenorphine or methadone for opioid use disorder. Participants will attend multiple online therapy sessions from their syringe services program and complete related activities between sessions with support from onsite coaches. As an unphased trial, this study offers a unique opportunity to explore new methods for managing PTSD symptoms and improving adherence to opioid use disorder treatments.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, it aims to help participants keep taking their medication for opioid use disorder, like Buprenorphine or methadone.

What prior data suggests that this adapted Cognitive Processing Therapy is safe for treating PTSD in adults using syringe services programs?

Research has shown that Cognitive Processing Therapy (CPT) is a safe and effective treatment for PTSD. Studies have found that CPT can significantly reduce PTSD symptoms without causing major side effects. This therapy helps change negative thoughts related to trauma and works well in various situations, even for individuals with substance use issues.

In past trials, participants who received CPT reported much better PTSD symptoms compared to those who did not receive the treatment. No serious negative effects were linked to the therapy. CPT's strong safety record makes it a promising choice for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Adapted Cognitive Processing Therapy is unique because it combines traditional Cognitive Processing Therapy (CPT) with a focus on individuals using syringe services programs, addressing both PTSD and opioid use disorder simultaneously. Unlike standard treatments that often focus separately on PTSD or substance use, this adapted version is delivered via telehealth, making it accessible and private for participants within syringe services programs. Researchers are excited about this approach because it tailors therapy to the specific needs of this population, potentially improving accessibility and effectiveness in treating both conditions together.

What evidence suggests that this adapted Cognitive Processing Therapy is effective for PTSD?

Research has shown that Cognitive Processing Therapy (CPT) can greatly reduce PTSD symptoms. For individuals dealing with both PTSD and substance use problems, CPT has proven more effective in improving PTSD symptoms than other methods. One study found that participants receiving CPT reported better improvements in their PTSD symptoms compared to those receiving different treatments. CPT works by changing how people think about their trauma, which can lessen their distress. This trial will test an adapted version of CPT, delivered via telehealth, specifically for individuals using syringe services programs. This therapy has been effective for veterans, who often face similar issues, suggesting it could also help others with PTSD and opioid use challenges. ^{1 3 6 7 8}

Who Is on the Research Team?

Teresa Lopez-Castro, PhD

Principal Investigator

The City College of New York, CUNY

Aaron D Fox, MD

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with PTSD who also use syringe services programs and have an opioid use disorder. They must be willing to attend telehealth therapy sessions and work with coaches at the program. Specific details on inclusion or exclusion criteria are not provided.

Inclusion Criteria

Ability to provide informed consent

Regular syringe services program attendance (ex. at least 4 visits in the past month)

Meeting DSM-5 opioid use disorder criteria

Exclusion Criteria

High risk for suicidal thoughts and/or behaviors that would make participation dangerous, as measured by the Columbia Suicide Severity Rating Scale Lifetime-Recent Screen

I have been diagnosed with a psychotic or bipolar disorder.

I am currently undergoing therapy for trauma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4-18 tele-delivered Cognitive Processing Therapy (CPT) sessions at the syringe services program

12 weeks

4-18 visits (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monthly surveys of PTSD symptoms, drug use, and mental health

4 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Adapted Cognitive Processing Therapy

Trial Overview

The study tests if Cognitive Processing Therapy (CPT) adapted for telehealth can reduce PTSD symptoms in those using syringe services while helping them continue their medication for opioid use disorder, like Buprenorphine or methadone.

How Is the Trial Designed?

Group I: Adapted Cognitive Processing Therapy Experimental Treatment 1 Intervention

Participants will receive 4-18 sessions of telehealth-delivered Cognitive Processing Therapy (CPT) adapted for people who use syringe services programs. Participants will attend the 50-minute CPT sessions in a private space within the syringe services program.

Who Is Running the Clinical Trial?

The City College of New York

Lead Sponsor

Trials

32

Recruited

6,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Albert Einstein College of Medicine

Collaborator

Trials

302

Recruited

11,690,000+

Published Research Related to This Trial

Cognitive Processing Therapy (CPT) is an effective evidence-based treatment for PTSD, particularly for individuals who have experienced combat, assault, or interpersonal violence, as supported by randomized controlled trials.

The Department of Veterans Affairs has successfully implemented CPT across its healthcare system, with trained clinicians showing good adoption of the therapy and significant improvements in patients' PTSD and depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. Chard, KM., Ricksecker, EG., Healy, ET., et al.[2022]

Cognitive Processing Therapy (CPT) significantly improved symptoms of military-related PTSD in veterans compared to usual treatment, as shown in a randomized controlled trial with 59 participants receiving 12 sessions of therapy.

CPT also led to greater reductions in anxiety, depression, and improvements in social relationships, with no reported adverse events, highlighting its safety and efficacy in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multisite randomized controlled effectiveness trial of cognitive processing therapy for military-related posttraumatic stress disorder. Forbes, D., Lloyd, D., Nixon, RD., et al.[2018]

Cognitive Processing Therapy (CPT) significantly improved PTSD and depression symptoms in 19 sexual assault survivors after 12 weekly group sessions, with benefits maintained for 6 months post-treatment.

In contrast, a comparison group of 20 individuals who waited for therapy showed no improvement, highlighting the efficacy of CPT in treating PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for sexual assault victims. Resick, PA., Schnicke, MK.[2022]

The TARGET model is a new approach designed to treat both posttraumatic stress disorder (PTSD) and substance use disorders simultaneously, focusing on trauma and emotion self-regulation.

The model is based on extensive research and clinical literature, providing a structured skill set for therapists to use in both individual and group therapy settings, which is illustrated through real-life case examples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused, present-centered, emotional self-regulation approach to integrated treatment for posttraumatic stress and addiction: trauma adaptive recovery group education and therapy (TARGET). Ford, JD., Russo, E.[2018]

Cognitive processing therapy (CPT) is an effective treatment for PTSD in veterans, but many do not complete the full program, often receiving only four sessions instead of the full 12, highlighting the need for a more efficient treatment format.

A study involving 270 veterans used a fractional factorial design to identify the most effective components of CPT, aiming to create a shorter version that could reduce dropout rates and improve treatment accessibility for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the multiphase optimization strategy to adapt cognitive processing therapy (CPT MOST): study protocol for a randomized controlled factorial experiment. Sripada, RK., Peterson, CL., Dziak, JJ., et al.[2023]

A pilot study involving 30 adults with co-occurring PTSD and opioid use disorder showed that providing financial incentives for attending Prolonged Exposure (PE) therapy significantly increased attendance rates (87% vs. 35%) compared to standard PE therapy.

Participants receiving PE with financial incentives also experienced greater reductions in PTSD symptoms and had lower rates of opioid use, with 0% testing positive for opioids compared to 22% in the treatment as usual group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged exposure therapy for PTSD in individuals with opioid use disorder: A randomized pilot study. Peck, KR., Badger, GJ., Cole, R., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5803416/

Development of a Novel, Integrated Cognitive-Behavioral ...

CPT targets PTSD symptoms through a focus on evaluating and changing trauma-related cognitions, particularly those relevant to five central themes: safety, ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0887618518300744

A cognitive processing therapy-based treatment program ...

Although preliminary evidence indicates that CPT is effective in reducing PTSD symptomatology and depression in veterans even when these symptoms are comorbid ...

3.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/add.70097

Effectiveness of treating post‐traumatic stress disorder in ...

Post-traumatic stress disorder (PTSD) and substance use disorder (SUD) are highly co-occurring and evidence for the optimal ways of treating ...

4.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0276111

Cognitive Processing Therapy or Relapse Prevention for ...

At post-treatment, participants assigned to CPT showed significantly greater improvement than those in AO on PTSD symptom severity (b = -9.72, ...

5.

ptsd.va.gov

ptsd.va.gov/professional/articles/article-pdf/id1643766.pdf

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

Cognitive processing therapy (CPT) versus individual drug counseling (IDC) for PTSD for veterans with opioid use disorder maintained on ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0887618521001377

Efficacy and acceptability of interventions for co-occurring ...

Results suggest that trauma-focused, non-trauma-focused, and manualized SUD interventions are sound options for individuals with comorbid PTSD/SUD.

7.

bmcpsychiatry.biomedcentral.com

bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06348-0

Study protocol for a randomized controlled trial to adapt a ...

This study will use eight study phases to adapt an existing evidence-based PTSD intervention, Skills Training in Affective and Interpersonal Regulation with ...

8.

link.springer.com

link.springer.com/article/10.1007/s10461-018-02382-8

Randomized Control Trial of Culturally Adapted Cognitive ...

Consistent with hypotheses, CPT had large and statistically significant effects in improving PTSD symptoms, both from pre- to post-treatment and ...