Psychotherapy for Psychosis, Adverse Events, and Substance Misuse

NCT04546178 | Completed

• 1 other identifier: REB1025608
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders; Stress Disorders, Traumatic; Substance Use

Keywords

Substance misuse; Schizophrenia spectrum disorders; Adversity; Cognitive Behavioral Therapy (CBT)

Outcome Measures

Primary Outcomes (5)

• Beck Hopelessness Scale (BHS); Change in hopelessness

  This 20-item true/false scale measures hopelessness in participants; we will use the total score on this measure as an indicator of hopelessness. Scores range from 0 to 20; higher scores indicate greater hopelessness. Detailed timeline: Pre-intervention baseline assessment (study week 1); pre-intervention follow-up appointments (study weeks 2; 2,3; or 2,3, and 4; depending on randomization); pre-intervention assessment 1 (study week 3,4, or 5, depending on randomization); intra-intervention assessment 2 (study week 6,7, or 8, depending on randomization); intra-intervention assessment 3 (study week 9,10, or 11, depending on randomization); intra-intervention assessment 4 (study week 12,13, or 14, depending on randomization); intra-intervention assessment 5 (study week 15,16, or 17, depending on randomization); intra-intervention assessment 6 (study week 18,19, or 20, depending on randomization); 8 weeks post-assessment 6 (week 18, 19, or 20); 9 weeks post-assessment 6

  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)

• Brief Experiential Avoidance Questionnaire (BEAQ); Change in avoidance

  This 15-item scale measures avoidance in participants; we will use the overall score on this measure as an indicator of avoidance. Scores range from 15 to 90; higher scores indicate greater avoidance. Detailed timeline: Pre-intervention baseline assessment (study week 1); pre-intervention follow-up appointments (study weeks 2; 2,3; or 2,3, and 4; depending on randomization); pre-intervention assessment 1 (study week 3,4, or 5, depending on randomization); intra-intervention assessment 2 (study week 6,7, or 8, depending on randomization); intra-intervention assessment 3 (study week 9,10, or 11, depending on randomization); intra-intervention assessment 4 (study week 12,13, or 14, depending on randomization); intra-intervention assessment 5 (study week 15,16, or 17, depending on randomization); intra-intervention assessment 6 (study week 18,19, or 20, depending on randomization); 8 weeks post-assessment 6 (week 18, 19, or 20); 9 weeks post-assessment 6 (week 18, 19, or 20)

  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)

• World Health Organization's Alcohol, Smoking, and Substance Involvement Screening Test (WHO ASSIST); Change in substance use

  The ASSIST measures substance use; we will use the total score for each substance as an indicator of substance use. Scores range from 0-39 for each subscale; higher scores indicate substance misuse. Detailed timeline: Eligibility screening assessment (pre-study enrollment); pre-intervention assessment 1 (study week 3,4, or 5, depending on randomization); intra-intervention assessment 2 (study week 6,7, or 8, depending on randomization); intra-intervention assessment 3 (study week 9,10, or 11, depending on randomization); intra-intervention assessment 4 (study week 12,13, or 14, depending on randomization); intra-intervention assessment 5 (study week 15,16, or 17, depending on randomization); intra-intervention assessment 6 (study week 18,19, or 20, depending on randomization); 8 weeks post-assessment 6 (week 18, 19, or 20); 9 weeks post-assessment 6

  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)

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

  The PANSS measures positive and negative psychotic symptoms; we will use the total score of the negative symptoms subscale on this measure as an indicator of negative symptoms. Scores range from 7 to 49; higher scores indicate greater negative symptoms.

  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)

• Social and Occupational Functioning Assessment Scale (SOFAS); Change in functioning

  This clinician-reported instrument measures social and occupational functioning. Scores on this measure range from 1 to 100; higher scores indicate greater functioning, lower scores indicate greater impairment in functioning. Detailed timeline: Pre-intervention follow-up appointments (study weeks 2; 2 and 3; or 2,3, and 4; depending on randomization to intervention start time); pre-intervention assessment 1 (study week 3,4, or 5, depending on randomization); intra-intervention assessment 2 (study week 6,7, or 8, depending on randomization); intra-intervention assessment 3 (study week 9,10, or 11, depending on randomization); intra-intervention assessment 4 (study week 12,13, or 14, depending on randomization); intra-intervention assessment 5 (study week 15,16, or 17, depending on randomization); intra-intervention assessment 6 (study week 18,19, or 20, depending on randomization); 8 weeks post-assessment 6 (week 18, 19, or 20); 9 weeks post-assessment 6 (week 18, 19, or 20)

  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 (4)

• Trauma Symptom Checklist-40 (TSC-40); Change in adversity sequelae

  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)

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

  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)

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

  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)

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

  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 (2)

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

  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.

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

  Eligibility assessment, 8 weeks post-assessment 6 (follow-up assessment 1).

Study Arms (2)

PE+ intervention group

EXPERIMENTAL

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.

Behavioral: Prolonged exposure (PE)+ therapy; Other: Treatment as usual (TAU)

Pre-intervention scores group (TAU)

ACTIVE COMPARATOR

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).

Other: Treatment as usual (TAU)

Interventions

Prolonged exposure (PE)+ therapy 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.

Also known as: PE+ therapy

PE+ intervention group

Treatment as usual (TAU) 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.

Also known as: Antipsychotics and program access

PE+ intervention group; Pre-intervention scores group (TAU)

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Queen Elizabeth II Health Sciences Centre Foundation: collaborator
• Research Nova Scotia: collaborator
• Killam Laureates: collaborator

Study Sites (1)

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

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Related Publications (2)

• 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.

  PMID: 39402517 DERIVED

• 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.

  PMID: 36578677 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Stress Disorders, Traumatic; Substance-Related Disorders

Interventions

Therapeutics; Antipsychotic Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Trauma and Stressor Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Officials

• Victoria Patterson, PhD student

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 11, 2020
• Study Start: November 15, 2021
• Primary Completion: September 15, 2023
• Study Completion: September 30, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)