Clinical trial NCT04546178: Psychotherapy for Psychosis, Adverse Events, and Substance Misuse
Official title: Implementation and Evaluation of Prolonged Exposure Psychotherapy for Adverse Events in Early Phase Psychosis With Comorbid Substance Misuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Stress Disorders, Traumatic
Substance Use
Keywords: Substance misuse
Schizophrenia spectrum disorders
Adversity
Cognitive Behavioral Therapy (CBT)
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Queen Elizabeth II Health Sciences Centre Foundation
name: Research Nova Scotia
name: Killam Laureates
First posted: 2020-09-11
Enrollment: 19
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Beck Hopelessness Scale (BHS); Change in hopelessness
timeFrame: 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)
measure: Brief Experiential Avoidance Questionnaire (BEAQ); Change in avoidance
timeFrame: 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)
measure: World Health Organization's Alcohol, Smoking, and Substance Involvement Screening Test (WHO ASSIST); Change in substance use
timeFrame: Eligibility assessment (week 0); 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)
measure: Positive and Negative Syndrome Scale (PANSS) - Negative subscale; Change in negative psychotic symptoms
timeFrame: Study week 1; pre-intervention assessment 1 (study week 3,4, or 5, depending on randomization); 8 weeks following study week 18,19, or 20 and 9 weeks post study week 18,19, or 20 (depending on randomization to intervention start time)
measure: Social and Occupational Functioning Assessment Scale (SOFAS); Change in functioning
timeFrame: 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)
Secondary outcomes:
measure: Trauma Symptom Checklist-40 (TSC-40); Change in adversity sequelae
timeFrame: 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)
measure: Positive and Negative Syndrome Scale (PANSS) - Positive subscale; Change in positive psychotic symptoms
timeFrame: Study week 1; pre-intervention assessment 1 (study week 3,4, or 5, depending on randomization); 8 weeks following study week 18,19, or 20 and 9 weeks post study week 18, 19, or 20 (depending on randomization to intervention start time)
measure: Clinical Global Impression - Severity of Illness and Improvement of Illness (CGI-S & -I); Change in functioning
timeFrame: Study week 1; depending on randomization to intervention start time: administered 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)
measure: PTSD Checklist for DSM-5 - 8-item screener version
timeFrame: 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)
Other outcomes:
measure: Session rating scale Version 3 (SRS V3); Change in therapeutic alliance
timeFrame: Depending on randomization to intervention start time, this measure is administered after each intervention session; meaning it is administered through study weeks 4 to 18; 5 to 19; or 6 to 20.
measure: Trauma and Life Events (TALE) checklist; Change in measurement of how much someone is affected by an adverse event
timeFrame: Eligibility assessment, 8 weeks post-assessment 6 (follow-up assessment 1).
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Early Psychosis Program (NSEPP), Abbie J. Lane Memorial Building
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Victoria Patterson, PhD student
role: PRINCIPAL_INVESTIGATOR
References: