Telemedicine Therapy for PTSD and Opioid Use Disorder

Overseen By Kelly Peck, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont

Must be taking: Methadone, Buprenorphine

Disqualifiers: Delusions, Hallucinations, Unstable bipolar, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new telemedicine therapy for individuals with both PTSD and opioid use disorder (OUD). The goal is to determine if this online therapy, called prolonged exposure therapy, can improve therapy attendance and reduce PTSD symptoms. Participants are divided into three groups: one receives standard treatment, another receives the online therapy, and the third receives the online therapy plus financial rewards for attending sessions. This trial is for individuals who have been on a steady dose of methadone or buprenorphine for more than a month and meet the criteria for PTSD. As an unphased trial, this study provides a unique opportunity to explore innovative therapy options that could enhance the treatment experience.

Will I have to stop taking my current medications?

The trial requires that participants stay on a stable dose of methadone, buprenorphine, or any psychotropic medications for more than one month before joining. So, you won't have to stop these medications if they are stable.

What prior data suggests that this telemedicine-delivered therapy protocol is safe for individuals with PTSD and OUD?

Research has shown that prolonged exposure (PE) therapy is a leading treatment for PTSD and is generally well-received by patients. Studies have found that it does not lead to an increase in the use of non-prescribed opioids or other drugs, meaning people do not start using more unprescribed drugs after treatment. One study found that offering financial rewards for attending PE therapy sessions increased attendance and led to significant improvements in PTSD symptoms.

While these studies provide encouraging information, the effects of PE therapy on individuals with both PTSD and opioid use disorder (OUD) are still under investigation. Participation in this trial will help gather important information about the safety and effectiveness of PE therapy for this specific group. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about prolonged exposure therapy (PE) for PTSD and opioid use disorder because it offers a new way to deliver therapy through telemedicine. Unlike standard treatments that focus primarily on medication like buprenorphine or methadone, PE provides structured psychological support via a secure, university-supported telemedicine platform. This innovative delivery method allows participants to receive therapy from home, making it more accessible and potentially increasing adherence to the treatment plan. Additionally, the study includes a variant with attendance contingent financial incentives (PE+), which could further motivate patients to complete their sessions, enhancing the overall effectiveness of the therapy.

What evidence suggests that this telemedicine therapy protocol is effective for PTSD and opioid use disorder?

Research shows that prolonged exposure therapy (PE) effectively treats posttraumatic stress disorder (PTSD). Studies have found that PE reduces PTSD symptoms and remains effective when delivered through telemedicine, which involves sessions over the phone or internet. One study found that this method improved therapy attendance and did not increase opioid use in individuals with both PTSD and opioid use disorder. In this trial, participants may receive PE alone or PE with attendance-contingent financial incentives (PE+), both delivered via telemedicine. While PE is a proven treatment for PTSD, telemedicine facilitates session attendance, helping patients adhere to therapy. Overall, evidence supports that PE can help individuals with PTSD and opioid use disorder feel better. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with PTSD and OUD who have been on a stable methadone or buprenorphine dose for at least one month. They must meet the DSM-5 criteria for PTSD and if taking psychotropic meds, be on a stable dose for over a month.

Inclusion Criteria

I have been on a steady dose of methadone or buprenorphine for over a month.

I am older than 18 years.

I have been on a stable dose of my mental health medication for over a month.

Exclusion Criteria

Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview

Cognitive impairment as evidenced by scores <22 on the Videoconference-based Mini Mental Status Examination (MMSE; Folstein, et al., 1975)

Enrolled in another ongoing evidence-based treatment for PTSD

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telemedicine-delivered prolonged exposure therapy consisting of 12 weekly sessions

12 weeks

12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 3 and 6 months post-study

What Are the Treatments Tested in This Trial?

Interventions

• Prolonged Exposure Therapy

Trial Overview The study tests telemedicine-delivered prolonged exposure therapy to see if it helps people with PTSD and OUD attend treatment sessions more regularly and reduce their PTSD symptoms compared to usual treatments plus financial incentives.

How Is the Trial Designed?

Group I: Prolonged exposure therapy + attendance contingent financial incentives (PE+) Experimental Treatment 3 Interventions

Participants assigned to the PE+ condition will receive the procedures noted above for the PE group plus financial incentives delivered contingent upon completion of PE sessions.

Group II: Prolonged exposure therapy (PE) Experimental Treatment 2 Interventions

In addition to receiving standard buprenorphine- or methadone-maintenance treatment from their current provider and completing scheduled assessments as described above, PE participants will also receive 12 individual sessions of prolonged exposure therapy scheduled weekly over the 12-week treatment period and delivered via a secure and university-supported telemedicine platform. Beginning in study week 1, PE participants will complete weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by doctoral or master's level therapists trained in prolonged exposure therapy.

Group III: Treatment as usual (TAU) Active Control 1 Intervention

Participants randomized to TAU will continue to receive standard buprenorphine or methadone maintenance treatment from their current treatment provider and complete follow-up assessments as described above. However, they will not receive posttraumatic stress disorder treatment. Staff will mail participants an emergency naloxone kit containing two naloxone doses with simple instructions, a list of resources and contact information for mental health providers and other relevant resources in their community and assistance contacting any resources of interest.

Prolonged Exposure Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Prolonged Exposure Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Approved in European Union as Prolonged Exposure Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Prolonged exposure therapy (PE) is recognized as a first-line treatment for posttraumatic stress disorder (PTSD), focusing on imaginal exposure to help patients process traumatic memories.

The article discusses the efficacy and safety of PE, as well as adaptations made for specific populations, such as Hispanics, and highlights challenges in implementing this therapy widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Emotional processing theory and prolonged exposure therapy for posttraumatic stress disorder]. Kichic, R., D'Alessio, N.[2018]

In a study of 31 combat veterans with PTSD undergoing prolonged exposure therapy, 9 out of 24 completers achieved complete remission from PTSD, indicating the therapy's potential efficacy.

The study found that successful remission from PTSD was associated with decreased activation in the left anterior insula during negative image anticipation and increased connectivity with other brain regions, suggesting that effective treatment may involve better regulation of anticipatory anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosubstrates of remission following prolonged exposure therapy in veterans with posttraumatic stress disorder. Simmons, AN., Norman, SB., Spadoni, AD., et al.[2021]

A training workshop on prolonged exposure (PE) therapy for PTSD significantly improved the self-efficacy and outcome expectations of 45 psychologists, leading to increased use of PE techniques in their practice.

The study highlights the importance of combining training with intensive consultation to enhance the delivery of evidence-based PTSD treatments, suggesting that such approaches could help more emergency service patients receive effective care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training plus intensive consultation improves uptake and outcome expectations of prolonged exposure therapy among practitioners treating emergency service personnel with post-traumatic stress disorder. Wade, D., Terhaag, S., Putica, A., et al.[2021]

Providers who received post-workshop consultation after a 4-day prolonged exposure therapy (PE) training reported significantly higher self-efficacy and used more components of PE, leading to better treatment delivery.

Patients treated by providers with post-workshop consultation experienced faster reductions in PTSD symptoms and lower severity at follow-up assessments, indicating that ongoing support for providers can enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. Foa, EB., McLean, CP., Brown, LA., et al.[2022]

Prolonged exposure (PE) therapy was found to be effective in reducing PTSD and depression symptoms in a small group of 10 Veterans with mild to moderate traumatic brain injury (TBI) and chronic PTSD, showing large effect sizes from pre- to posttreatment.

The therapy was safely adapted for Veterans with cognitive impairments, indicating that PE can be a viable treatment option for this population, with significant symptom improvements observed after 8 to 18 sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary examination of prolonged exposure therapy with Iraq and Afghanistan veterans with a diagnosis of posttraumatic stress disorder and mild to moderate traumatic brain injury. Wolf, GK., Strom, TQ., Kehle, SM., et al.[2022]

Prolonged Exposure (PE) therapy is a safe and effective treatment for PTSD, with a study of 361 female assault survivors showing no reliable worsening of PTSD symptoms and low rates of depression worsening among those who received PE.

Participants receiving PE and other active treatments demonstrated significant improvements in PTSD and depression compared to those on a waitlist, highlighting the importance of treatment in preventing symptom deterioration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primum non nocere (first do no harm): symptom worsening and improvement in female assault victims after prolonged exposure for PTSD. Jayawickreme, N., Cahill, SP., Riggs, DS., et al.[2014]

A study involving 160 active-duty military personnel with PTSD found that 60-minute prolonged exposure (PE) therapy sessions are just as effective as the standard 90-minute sessions, making treatment more accessible in settings that typically use shorter appointment times.

Both the Clinician Administered PTSD Scale (CAPS-5) and the PTSD Checklist (PCL-5) showed that the efficacy of 60-minute sessions was noninferior to 90-minute sessions, suggesting that shorter sessions can be effectively implemented without compromising treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. Foa, EB., Bredemeier, K., Acierno, R., et al.[2022]

A pilot study involving 12 veterans with combat-related PTSD showed that prolonged exposure therapy (PE) delivered via telehealth resulted in significant reductions in self-reported PTSD symptoms, indicating its efficacy.

The study also demonstrated the feasibility and safety of using telehealth for PE, with positive outcomes suggesting it could be a practical alternative to in-person therapy for veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of prolonged exposure therapy for posttraumatic stress disorder delivered via telehealth technology. Tuerk, PW., Yoder, M., Ruggiero, KJ., 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]

In a pilot study involving 12 female patients in a methadone program who were survivors of child sexual abuse or rape, prolonged exposure therapy (PE) led to significant reductions in PTSD and depressive symptoms after treatment and at 12-month follow-ups.

The study found no relapses to illicit drug use among participants, suggesting that PE therapy can be effectively delivered by social workers in methadone clinics, warranting further research in a randomized control trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged Exposure for Treating PTSD Among Female Methadone Patients Who Were Survivors of Sexual Abuse in Israel. Schiff, M., Nacasch, N., Levit, S., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06288711

Novel Telemedicine-Delivered Prolonged Exposure ... The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10291821/

Prolonged exposure therapy for PTSD in individuals with ... These findings provide preliminary support for the efficacy of PE+ for improving PE attendance and PTSD symptoms without prompting opioid relapse in individuals ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871624014327

A novel prolonged exposure therapy protocol for improving ... This randomized trial evaluated the efficacy of a novel protocol for improving PE attendance and PTSD symptoms among adults receiving buprenorphine or ...

4. reporter.nih.gov reporter.nih.gov/project-details/11086748

Project Details - NIH RePORTER Although Prolonged Exposure (PE) therapy is a first-line treatment for PTSD, its efficacy is commonly undermined by poor attendance. We recently demonstrated ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460323000837

Prolonged exposure therapy for PTSD in individuals with ... Nearly 90% of individuals with OUD report lifetime trauma exposure and 33% meet DSM diagnostic criteria for PTSD (Mills et al., 2005, Mills et al., 2006, Peirce ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36989699/

Prolonged exposure therapy for PTSD in individuals with ... Results: PE+ participants attended significantly more therapy sessions vs. PE (87% vs. 35%; p <.0001). PTSD symptom reductions were also ...