Be Outspoken and Overcome Stigmatizing Thoughts (BOOST) Group for Early Psychosis

NCT05571228 | Unknown

• 1 other identifier: PSYC-242-20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Internalized stigma, (i.e. the application of negative stereotypes about a diagnostic group to one's self) is a strong predictor of recovery and quality of life for individuals with psychosis. Be Outspoken and Overcome Stigmatizing Thoughts (BOOST) is an evidence-based intervention aimed at improving internalized stigma, self-esteem, and quality of life for those with psychosis. The proposed research expands BOOST's program by adding additional therapeutic methods and material, and adopting the use of virtual care methods to: (a) increase the generalization of treatment effects, (b) examine long-term treatment effects, and (C) provide rural Ontario communities with remote treatment access.

Conditions

Schizophrenia; Psychosis

Keywords

Early Psychosis; Remote treatment

Outcome Measures

Primary Outcomes (1)

• Internalized stigma

  This project will assess how virtual BOOST treatment changes psychological factors associated with recovery. The primary outcome measure is internalized stigma as measured by the Internalized Stigma of Mental Illness Scale.

  Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.

Secondary Outcomes (8)

• Self-Injurious Thoughts and Behaviours Interview Self-Report

  Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.

• Interpersonal Hopelessness Scale

  Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.

• Interpersonal Needs Questionnaire

  Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.

• Rosenberg Self-Esteem Scale

  Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.

• Patient Health Questionnaire

  Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.

Study Arms (1)

Internalized stigma group

EXPERIMENTAL

BOOST is an 8 session group intervention, delivered over 4 weeks. The program uses evidence based therapeutic techniques and integrates cognitive behavioural therapy and peer support to reduce or prevent the internalization of stigma in early psychosis. Sessions 1-4 focus on dispelling stigmatizing myths about psychosis and evaluating the accuracy of group members or societies stigmatizing beliefs in order to normalize experiences associated with and reactions to the symptoms of psychosis. Sessions 5-8 teach behavioural approaches for self-empowerment through social skills training, development of assertiveness skills, and goal setting. Role-plays that are specific to young people with psychosis, which were co-developed with people with lived experience, provide opportunities to practice these skills in session. During role plays, participants monitor stigmatizing beliefs that may interfere with communication or pursuing goals.

Behavioral: Self-stigma intervention

Interventions

Self-stigma intervention BEHAVIORAL

Be Outspoken and Overcome Stigmatizing Thoughts (BOOST) is a group-based intervention integrating cognitive behavioural therapy (CBT) and peer support to reduce or prevent the internalization of stigma in early psychosis. The BOOST group will last for 4 weeks and consists of two 1-hour sessions per week. Participants will be assessed prior to the first group, following the final group, six months after the group ends, and twelve months after the group ends.

Also known as: Be Outspoken and Overcome Stigmatizing Thoughts (BOOST)

Internalized stigma group

Eligibility Criteria

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

You may qualify if:

• Diagnosis of schizophrenia, schizoaffective disorder or any other psychotic disorder
• Must be 18-35 years of age
• Know how to use a computer and telephone
• Not abusing drugs or alcohol
• Can read and speak English

You may not qualify if:

• Individuals enrolled in a cognitive behavioural therapy program in the last 6 months
• Individuals with neurological disease or neurological damage
• Individuals with medical illnesses that can change neurocognitive function
• Individuals with a medical history of a head injury with loss of consciousness
• Physical handicaps that would prevent an individual from engaging in the BOOST program

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3J9, Canada

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Christopher R Bowie, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Clinical Training Department with the Psychology

Model Details: Consultation with our lived-experience advisory group, consisting of service-users and family members, supports our decision to use a single-arm, non-randomized trial design. All participants recruited into the study will receive the intervention. Results of single arm interventions can provide rich data using data analytic techniques such as Reliable Change Index and will allow us to examine mediators of change from the intervention to continue to refine its efficacy.

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: October 7, 2022
• Study Start: October 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)