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

Trial Summary

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 data supports the effectiveness of the treatment Adapted Cognitive Processing Therapy for PTSD and Opioid Use Disorder?

Cognitive Processing Therapy (CPT) has been shown to significantly improve PTSD and depression symptoms in sexual assault survivors and military veterans, with benefits maintained for several months. Additionally, CPT has been effective in reducing PTSD symptoms and improving anxiety, depression, and social relationships in military veterans, suggesting its potential effectiveness for individuals with PTSD and Opioid Use Disorder. ^{1 2 3 4 5}

Is Cognitive Processing Therapy (CPT) safe for humans?

Cognitive Processing Therapy (CPT) has been widely used and studied for treating PTSD, including in military veterans and sexual assault victims, with no reported adverse events related to the therapy itself. ^{1 3 4 5 6}

How is Adapted Cognitive Processing Therapy different from other treatments for PTSD and opioid use disorder?

Adapted Cognitive Processing Therapy (CPT) is unique because it focuses on identifying the most effective components of traditional CPT to create a shorter, more accessible treatment for PTSD, which is crucial since many patients do not complete the full course. This adaptation aims to address both PTSD and opioid use disorder by enhancing emotional self-regulation and executive control, potentially offering a more integrated approach compared to standard treatments. ^{1 5 7 8 9}

What is the purpose of this trial?

The goal of this open pilot trial is to learn if an adapted version of Cognitive Processing Therapy (CPT), delivered through telehealth, can treat posttraumatic stress disorder (PTSD) in adults who use syringe services programs. The main questions it aims to answer are: * Can the intervention be done in syringe services programs? * Are syringe services program clients and staff open to the intervention? * Can the intervention lower PTSD symptoms and help participants keep taking their medication for opioid use disorder (ex. Buprenorphine or methadone)? Participants will: * Attend 4-18 tele-delivered CPT sessions at the syringe services program * Complete between-session CPT practice with the support of SSP-based "coaches" * Meet with research staff monthly to complete surveys of their PTSD symptoms, drug use, and mental health

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A participant-randomized pilot hybrid II trial of group cognitive processing therapy for incarcerated persons with posttraumatic stress and substance use disorder symptoms: study protocol and rationale. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Prolonged exposure therapy for PTSD in individuals with opioid use disorder: A randomized pilot study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for sexual assault victims. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A multisite randomized controlled effectiveness trial of cognitive processing therapy for military-related posttraumatic stress disorder. [2018]

5. England 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Neurocircuitry basis of the opioid use disorder-post-traumatic stress disorder comorbid state: conceptual analyses using a dimensional framework. [2022]

8. United States 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). [2018]

9. Ireland pubmed.ncbi.nlm.nih.gov

The effect of post-traumatic stress disorder on the risk of developing prescription opioid use disorder: Results from the National Epidemiologic Survey on Alcohol and Related Conditions III. [2020]