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Psychotherapy for Psychosis, Adverse Events, and Substance Misuse

NCT ID: NCT04546178

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2023-09-30

Brief Summary

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People with psychosis have significantly higher rates of adversity (e.g., abuse) and substance misuse (i.e., problematic drug and alcohol use) than people with other mental illnesses. Research has found that adversity and substance use both negatively influence recovery from a psychotic disorder. Currently, there are few treatment options for people living with psychosis, substance misuse, and adversity-related symptoms (e.g., anxiety, depression). This is especially true for young adults who are in the first years of a psychotic illness (i.e., early phase psychosis; EPP) who may be in the best position to benefit from treatment because they have not been ill for as long as others with more chronic psychosis (i.e., \>10 years). Research has demonstrated that Prolonged Exposure (PE), a psychological therapy that helps improve adversity-related symptoms, may be appropriate for people in EPP, although there is limited evidence regarding its adaptation from use in chronic psychosis to EPP. The aim of the proposed study is to adapt and optimize PE therapy for young adults in EPP. We aim to recruit 20 individuals from the Nova Scotia Early Psychosis Program (NSEPP) aged 19-35 who will participate in 15 sessions of adapted PE; we will compare their scores before and after treatment on measures of psychotic symptoms, amount and frequency of substance use, and adversity-related problems. Our goal is to target two factors that may be contributing to and maintaining negative outcomes: avoidance and hopelessness. These factors will be addressed by asking participants to face feared reminders of adversity and learn new ways to think about adverse experiences and mental health problems. The adaptation and application of this evidence-based intervention has the potential to create a new treatment avenue for EPP, reducing impairment and distress, and improving recovery rates.

Detailed Description

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Conditions

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Psychotic Disorders Stress Disorders, Traumatic Substance Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A single-case experimental design (SCED), specifically, a multiple-baseline design (MBD; Kratochwill et al., 2010) will be used; the MBD temporally staggers intervention start times across participants, thereby creating a control group composed of each individual's pre-intervention scores. Randomization of each participant's treatment start time will be used to increase internal validity and minimize bias (Kratochwill \& Levin, 2010). Participants will be randomized using a random sampling/assignment generator (randomizer.org). An MBD is an ideal design for a study focused on the optimization of PE+ and this approach will allow a fine-grained assessment (Lobo et al., 2017) of its effectiveness in EPP. This design can also detect significant changes during each phase of the intervention. In order to meet standards of evidence for SCEDs, this study will include a total of five treatment phases, which exceeds the recommended minimum of three phases (Kratochwill et al., 2010).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The trained therapist conducting the symptom assessments will not have access to information regarding that participant's treatment, and the person providing the treatment will not have access to the information regarding assessments of that participant's symptoms. Therapists will only conduct a symptom assessment for participants that are working with another therapist; they may not conduct a symptom assessment for participants with whom they are working through the intervention.

Study Groups

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PE+ intervention group

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 Type EXPERIMENTAL

Prolonged exposure (PE)+ therapy

Intervention Type BEHAVIORAL

The intervention will be adapted prolonged exposure therapy, called PE+ therapy. Participants will receive 15 weekly 90-minute sessions of PE+; these appointments will be divided into five sets of three sessions each: 1) psychoeducation about AEs, SM, and the interplay of both with psychosis; 2) emotion regulation strategies; 3) imaginal exposures, 4) in vivo exposures, and 5) review of treatment and planning for termination and maintenance.

Treatment as usual (TAU)

Intervention Type OTHER

The intervention will be antipsychotics prescribed by clinicians working within the Nova Scotia Early Psychosis Program (NSEPP) as well as case management supplied by their primary nurse. Program participants will have access to educational programs about psychosis, skills/vocational training, as well as familial education and support.

Pre-intervention scores group (TAU)

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).

Group Type ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type OTHER

The intervention will be antipsychotics prescribed by clinicians working within the Nova Scotia Early Psychosis Program (NSEPP) as well as case management supplied by their primary nurse. Program participants will have access to educational programs about psychosis, skills/vocational training, as well as familial education and support.

Interventions

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Prolonged exposure (PE)+ therapy

The intervention will be adapted prolonged exposure therapy, called PE+ therapy. Participants will receive 15 weekly 90-minute sessions of PE+; these appointments will be divided into five sets of three sessions each: 1) psychoeducation about AEs, SM, and the interplay of both with psychosis; 2) emotion regulation strategies; 3) imaginal exposures, 4) in vivo exposures, and 5) review of treatment and planning for termination and maintenance.

Intervention Type BEHAVIORAL

Treatment as usual (TAU)

The intervention will be antipsychotics prescribed by clinicians working within the Nova Scotia Early Psychosis Program (NSEPP) as well as case management supplied by their primary nurse. Program participants will have access to educational programs about psychosis, skills/vocational training, as well as familial education and support.

Intervention Type OTHER

Other Intervention Names

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PE+ therapy Antipsychotics and program access

Eligibility Criteria

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Inclusion Criteria

* Current patient at the Nova Scotia Early Psychosis Program (NSEPP) for the duration of the study
* Aged 19-35 years
* Diagnosis of a primary psychotic disorder (i.e., schizotypal disorder, delusional disorder, brief psychotic disorder, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance/medication-induced psychotic disorder, other specified schizophrenia spectrum and other psychotic disorder, unspecified schizophrenia spectrum and other psychotic disorder)
* Diagnosis of a primary psychotic disorder within the past 5 years; participants must not surpass this 5-year diagnostic window whilst enrolled in the study
* Have experienced 1 or more negative, distressing lifetime adverse events (e.g., child abuse, discrimination) listed on the Trauma and Life Events (TALE) checklist that the participant indicates still affects them now
* At least one score within the "moderate" or "high" risk range for any substance (except tobacco products) on the WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
* Speaks and understands English

Exclusion Criteria

* Aged 36 and older
* Aged 18 and younger
* Score in the 'high risk' range for cocaine use on the ASSIST
* Participant does not speak or understand English
* Current involuntary inpatient admission in a hospital or under a Community Treatment Order
* 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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Elizabeth II Health Sciences Centre Foundation

UNKNOWN

Sponsor Role collaborator

Research Nova Scotia

UNKNOWN

Sponsor Role collaborator

Killam Laureates

UNKNOWN

Sponsor Role collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role lead

Responsible Party

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Victoria Patterson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victoria Patterson, PhD student

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University

Locations

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Nova Scotia Early Psychosis Program (NSEPP), Abbie J. Lane Memorial Building

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

References

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Patterson VC, Tibbo PG, Stewart SH, Town J, Crocker CE, Ursuliak Z, Lee S, Morrison J, Abidi S, Dempster K, Alexiadis M, Henderson N, Pencer A. Outcomes of an adapted prolonged exposure psychotherapy for people with early phase psychosis, substance misuse, and a history of adversity: the PE + trial. BMC Psychiatry. 2024 Oct 14;24(1):684. doi: 10.1186/s12888-024-06050-1.

Reference Type DERIVED
PMID: 39402517 (View on PubMed)

Patterson VC, Tibbo PG, Stewart SH, Town J, Crocker CE, Ursuliak Z, Lee S, Morrison J, Abidi S, Dempster K, Alexiadis M, Henderson N, Pencer A. A multiple baseline trial of adapted prolonged exposure psychotherapy for individuals with early phase psychosis, comorbid substance misuse, and a history of adversity: A study protocol. Front Psychol. 2022 Dec 12;13:1012776. doi: 10.3389/fpsyg.2022.1012776. eCollection 2022.

Reference Type DERIVED
PMID: 36578677 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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REB1025608

Identifier Type: -

Identifier Source: org_study_id