Psychotherapy for Psychosis, Adverse Events, and Substance Misuse

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

19 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to help young adults with early-phase psychosis by using a therapy called Prolonged Exposure (PE). PE helps them face and process difficult past experiences to reduce fear and hopelessness. The goal is to improve their recovery by addressing issues related to substance misuse and adversity.

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.

Research Team

Victoria Patterson, PhD student

Principal Investigator

Dalhousie University

Eligibility Criteria

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

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

Treatment Details

Interventions

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

Participant Groups

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+