Prolonged Exposure Therapy for Psychosis

Overseen By Victoria Patterson, PhD student

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Cocaine use, Intellectual disability, others

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

Compensation: Varies

Number of Visits: 17

Duration: 15 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young adults dealing with early-phase psychosis, substance misuse, and the aftermath of difficult life experiences. The goal is to adapt a therapy called Prolonged Exposure (PE) to improve mental health outcomes by teaching participants to confront their fears and reframe their thoughts about past adversities. Participants will be divided into two groups: one will receive PE therapy, and the other will receive standard care, known as Treatment as Usual (TAU), before eventually crossing over to the therapy group. This trial may suit individuals aged 19-35 with a psychotic disorder diagnosed within the last five years, who have faced significant life challenges and currently misuse substances (excluding tobacco). As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health research and potentially benefit from a novel therapeutic approach.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that you are not currently participating in any intervention designed to reduce substance use or treat symptoms related to adverse events.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Prolonged Exposure (PE) therapy is generally safe for individuals with mental health issues. Many studies have found that it can significantly reduce symptoms of post-traumatic stress disorder (PTSD) without increasing drug use. For instance, one study found that 83% of participants experienced a significant reduction in PTSD symptoms after PE therapy. Another study showed that PE therapy did not lead to an increase in the use of non-prescribed drugs, reassuring those dealing with substance misuse. Overall, these findings suggest that PE therapy is well-tolerated and can be a safe treatment option for trauma-related problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Prolonged exposure (PE)+ therapy is unique because it combines traditional psychotherapy with techniques specifically designed for individuals with psychosis who also face substance misuse and adverse life events. Unlike standard treatments that primarily focus on medication and broad-based support, PE+ therapy emphasizes confronting and processing trauma in a structured way, which may help reduce symptoms of both psychosis and substance misuse more effectively. Researchers are excited about this approach because it could provide a more holistic treatment, potentially improving outcomes for patients who haven't fully responded to existing therapies.

What evidence suggests that Prolonged Exposure therapy could be an effective treatment for early phase psychosis?

Research has shown that Prolonged Exposure (PE) therapy, which participants in this trial may receive, can help reduce symptoms related to trauma and difficult experiences. Studies have found that PE therapy can lessen issues such as depression, anxiety, and substance use disorders in people with PTSD, a condition caused by experiencing or witnessing a traumatic event. One study found that PE therapy significantly reduced feelings of paranoia and depression while also improving overall daily functioning. Another study noted that many people no longer met the criteria for PTSD after PE therapy, indicating significant symptom improvement. These findings suggest that PE therapy could also benefit those with early signs of psychosis by addressing similar symptoms and aiding in recovery. Meanwhile, participants in the trial's other arm will receive Treatment as Usual (TAU), which includes medication for psychosis and access to standard education programs and clinical care. ^{2 4 5 6 7}

Who Is on the Research Team?

Victoria Patterson, PhD student

Principal Investigator

Dalhousie University

Are You a Good Fit for This Trial?

Inclusion Criteria

Aged 19-35 years

Speaks and understands English

Current patient at the Nova Scotia Early Psychosis Program (NSEPP) for the duration of the study

Exclusion Criteria

Participant does not speak or understand English

Documented, diagnosed intellectual disability (ID)

Not currently participating in any intervention designed to reduce substance use or treat symptoms related to adverse events (e.g., PTSD)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Pre-intervention

Baseline assessments and follow-up appointments to establish pre-intervention scores

2-4 weeks

Multiple visits depending on randomization

Treatment

Participants receive 15 sessions of adapted Prolonged Exposure (PE) therapy

15 weeks

15 therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 weeks

2 follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Prolonged exposure (PE)+ therapy
• Treatment as usual (TAU)

How Is the Trial Designed?

Group I: PE+ intervention group Experimental Treatment 2 Interventions

This group will participate in 15 sessions of PE+ therapy and participate in frequent symptom assessments; this is the same group of participants as the pre-intervention scores group, but they have crossed over from pre-intervention phase into intervention (active) phase.

Group II: Pre-intervention scores group (TAU) Active Control 1 Intervention

This group will participate in symptom assessments but will not receive the PE+ intervention until the begin the active part of the trial. Participants in this group have been diagnosed with a psychotic disorder, have also experienced adversity, and use substances. This group will receive medication for psychosis as well as access to standard education programs and clinical care; thus treatment as usual (TAU).

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Killam Laureates

Collaborator

Trials

1

Recruited

20+

Queen Elizabeth II Health Sciences Centre Foundation

Collaborator

Trials

1

Recruited

20+

Research Nova Scotia

Collaborator

Trials

3

Recruited

600+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38411129/

Impact of three variants of prolonged exposure therapy on ... PE for PTSD resulted in reductions in comorbid diagnoses of depressive, anxiety, substance use and personality disorders.

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

A novel prolonged exposure therapy protocol for improving ... PE+ yielded high rates of PTSD diagnostic remission (83 %). •. PE was not associated with an increase in non-prescribed opioid or other drug use ...

3. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2808302

Written Exposure Therapy vs Prolonged ... This randomized clinical trial compares treatment outcomes for written exposure therapy and prolonged exposure therapy among veterans ...

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2022.1012776/full

A multiple baseline trial of adapted prolonged exposure ... PE therapy also appeared to significantly reduce paranoia and depressive symptoms and improve functioning (de Bont et al., 2016). Grubaugh et al ...

5. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/prolonged_exposure_pro.asp

Prolonged Exposure for PTSD - PTSD: National Center for ... The review concluded that there is high strength of evidence to support the efficacy of exposure therapy such as PE for reduction of PTSD symptoms and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11479562/

Outcomes of an adapted prolonged exposure ... Several adversity-focused treatment trials have reported improvements to adversity sequelae (e.g., PTSD symptoms) and decreases in psychotic ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2788220

Comparison of Prolonged Exposure vs Cognitive ... Prolonged exposure was more effective than cognitive processing therapy for reducing PTSD symptoms, but the difference between treatments did ...