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Prolonged exposure (PE)+ therapy for Psychosis

N/A

Waitlist Available

Led By Victoria Patterson, PhD student

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study weeks 1, 2; depending on randomization to intervention start time: administered weeks 3 through 20, 8 weeks following study week 18,19, or 20, and 9 weeks following study week 18,19, or 20 (see description above for more detail)

Awards & highlights

Study Summary

This trial will test whether an evidence-based therapy called Prolonged Exposure (PE) can be adapted and used to help young adults in early phase psychosis (EPP) who are also struggling with substance misuse and adversity-related symptoms.

Eligible Conditions

Psychosis
Traumatic Stress Disorders
Substance Abuse

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study weeks 1, 2; depending on randomization to intervention start time: administered weeks 3 through 20, 8 weeks following study week 18,19, or 20, and 9 weeks following study week 18,19, or 20 (see description above for more detail)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study weeks 1, 2; depending on randomization to intervention start time: administered weeks 3 through 20, 8 weeks following study week 18,19, or 20, and 9 weeks following study week 18,19, or 20 (see description above for more detail)

This trial's timeline: 3 weeks for screening, Varies for treatment, and study weeks 1, 2; depending on randomization to intervention start time: administered weeks 3 through 20, 8 weeks following study week 18,19, or 20, and 9 weeks following study week 18,19, or 20 (see description above for more detail) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Beck Hopelessness Scale (BHS); Change in hopelessness

Brief Experiential Avoidance Questionnaire (BEAQ); Change in avoidance

Positive and Negative Syndrome Scale (PANSS) - Negative subscale; Change in negative psychotic symptoms

+2 more

Secondary outcome measures

Clinical Global Impression - Severity of Illness and Improvement of Illness (CGI-S & -I); Change in functioning

PTSD Checklist for DSM-5 - 8-item screener version

Syndrome

+1 more

Other outcome measures

Session rating scale Version 3 (SRS V3); Change in therapeutic alliance

Trauma and Life Events (TALE) checklist; Change in measurement of how much someone is affected by an adverse event

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PE+ intervention groupExperimental Treatment2 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 Control1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prolonged exposure (PE)+ therapy

2021

N/A

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Killam LaureatesUNKNOWN

Nova Scotia Health AuthorityLead Sponsor

258 Previous Clinical Trials

83,835 Total Patients Enrolled

2 Trials studying Psychosis

142 Patients Enrolled for Psychosis

Queen Elizabeth II Health Sciences Centre FoundationUNKNOWN

Media Library

Prolonged exposure (PE)+ therapy Clinical Trial Eligibility Overview. Trial Name: NCT04546178 — N/A

Psychosis Research Study Groups: Pre-intervention scores group (TAU), PE+ intervention group

Psychosis Clinical Trial 2023: Prolonged exposure (PE)+ therapy Highlights & Side Effects. Trial Name: NCT04546178 — N/A

Prolonged exposure (PE)+ therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04546178 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for participants in this trial beyond thirty years of age?

"This medical trial is open to individuals aged 19-35. Conversely, there are 437 trials for minors and 1204 studies specifically targeting the elderly population."

Answered by AI

What key insights are researchers hoping to gain from this investigation?

"This clinical trial seeks to assess the efficacy of a novel intervention by monitoring patient's Beck Hopelessness Scale (BHS) and Trauma Symptom Checklist-40 (TSC-40). Secondary objectives include measuring any changes in adversity sequelae via TSC-40 total scores and subscale dissociation, anxiety, depression. In addition, participants will be evaluated using Clinical Global Impression - Severity of Illness and Improvement of Illness (CGI-S & -I), as well as PTSD Checklist for DSM 5 - 8 item screener version at pre-intervention baseline assessment; prior to intervention start"

Answered by AI

Do I meet the prerequisites to take part in this medical experiment?

"This trial is accepting 20 young adults with schizophrenia between the ages of 19 and 35. Eligible applicants must meet a range of requisites, including but not limited to: diagnosis within 5 years; being an active patient at NSEPP; moderate/high risk for substance abuse according to WHO's ASSIST test; having sustained one or more negative life events listed on TALE checklist that still affects them."

Answered by AI

Are there any unfilled slots currently available for participation in this experiment?

"Clinicaltrials.gov data attests that this medical experiment is actively seeking participants, and was first publicized on November 15th 2021 before being updated most recently on April 1st 2022."

Answered by AI

How many participants currently comprise this experiment?

"Yes, the details displayed on clinicaltrials.gov indicate that enrollment is still open for this investigative trial which was first published on November 15th 2021. Specifically, 20 individuals are needed at just one centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Psychotherapy for Psychosis, Adverse Events, and Substance Misuse

Victoria Patterson 2021. "Psychotherapy for Psychosis, Adverse Events, and Substance Misuse". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04546178.