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

November 14, 2023 updated by: Dr. Christopher Bowie, Queen's University
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.

Study Overview

Status

Active, not recruiting

Detailed Description

Internalized stigma, defined as the application of negative stereotypes about a diagnostic group to one's self, is a strong predictor of quality of life and recovery in schizophrenia and other psychoses, accounting for over half the variance. However, few effective interventions for self-stigma have been developed and even fewer individuals have access to these services.

Be Outspoken and Overcome Stigmatizing Thoughts (BOOST) is an evidence-based intervention developed by the research team that has significantly improved internalized stigma, self-esteem, and quality of life for young people with psychosis. This group therapy was co-created and is co-facilitated by people with lived experience with psychosis specifically for the early psychosis population. The proposed research expands this intervention by examining the efficacy of group delivery through virtual methods that could allow us to reach individuals that are unlikely to attend regular in-person sessions for a variety of reasons.

Psychotic disorders are among the most highly stigmatized mental health conditions. Over 50% of individuals with schizophrenia and other psychoses report significant internalization of these stigmatizing attitudes. Internalized stigma is defined as the application of societally held stereotypes about the illness to one's self. It is associated with a broad array of significant psychosocial consequences including reduced social functioning, isolation, and reduced rates of recovery. Internalized stigma is also associated with serious decrements in self-esteem, self-efficacy, and hope. Reducing internalized stigma has been recognized as such a critical factor in recovery from psychosis that both the World Health Organization and National Institute for Health and Care Excellence prioritize the reduction of stigma to improve recovery from psychosis.

Despite the clear importance of reducing internalized stigma in psychosis, few interventions have been developed to reduce internalized stigma about mental illness. Only a single intervention had previously been developed to specifically reduce internalized stigma among individuals in the early stages of psychosis. None of these internalized stigma interventions have demonstrated strong evidence for efficacy. The current approaches to reducing internalized stigma have focused almost exclusively on psychoeducation about psychosis, without evidence-based therapeutic techniques, and with treatment later in illness, when self-stigma has already set in. The investigators developed Be Outspoken and Overcome Stigmatizing Thoughts (BOOST), a group-based intervention integrating cognitive behavioural therapy (CBT) and peer support to reduce or prevent the internalization of stigma in early psychosis. Peer support is an especially important intervention for psychosis as peer support workers provide personal examples to normalize experiences that clients are having. Peer support has been demonstrated to improve social functioning and recovery for individuals with psychosis. Thus, the investigators propose that the combination of these approaches would be ideal to reduce internalized stigma.

In the initial pilot study[13], BOOST demonstrated significant improvements in internalized stigma, self-esteem, and quality of life. Despite BOOST demonstrating the largest effect size improvement on internalized stigma of any intervention currently evaluated (Cohen's d = 0.76), this was a small non-randomized sample, so the investigators would like to build the evidence base for the intervention and examine the breadth of treatment effects.

Proposed Solution Description:

BOOST is an 8-session group intervention, delivered over 4 weeks, near the time of psychosis onset. BOOST is the only intervention that integrates cognitive behavioural therapy with peer support, and these two intervention work synergistically to reduce internalized stigma. Interactive sessions are co-led by a psychologist or doctoral level psychology student and a peer support worker with lived experience. 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. Exercises include identifying the effects of self-labelling, evaluating self-stigmatizing beliefs, and testing the dimensionality of experiences associated with psychosis. All of these exercises are designed to help participants develop new ways of thinking that more accurately reflect the evidence, to build confidence in their capacity to recognize and modify negative self-attributions, and provide hope for the future. Sessions 5-8 teach behavioural approaches for self-empowerment through social skills training, development of assertiveness skills, and goal setting. Discussions in group are focused on the verbal and non-verbal characteristics of passive, aggressive, and assertive communication, as well as how to develop social communication and problem-solving skills. 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. Throughout each session, the peer support worker uses both prepared and spontaneous examples from their experiences of internalized stigma, negative beliefs, communication, and recovery in order to normalize experiences and instill hope. This is an interactive intervention designed for individuals of all cultural backgrounds. Although the internalized stigma belief content may be different in different cultures, the process of evaluating and normalizing experiences is consistent across demographic and geographic factors. Inclusion of a wide geographic sample in this project enhances the ability to generate a diverse set of content during group discussions.

Preliminary BOOST findings show large statistical effects in changing variables predictive of future suicidal ideation and behaviour, such as self-esteem and internalized stigma. The goal of the proposed research is to conduct a trial to examine how effective this group treatment for self-stigma, co-developed and co-facilitated by service users is when delivered through virtual care.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Kingston, Ontario, Canada, K7L 3J9
        • Queen's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internalized stigma group
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.
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.
Other Names:
  • Be Outspoken and Overcome Stigmatizing Thoughts (BOOST)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internalized stigma
Time Frame: Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Injurious Thoughts and Behaviours Interview Self-Report
Time Frame: Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.
Cognition associated with risk of suicide
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
Time Frame: Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.
Cognition associated with hopelessness
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
Time Frame: 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 measure
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
Time Frame: Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.
Self-esteem measure
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
Time Frame: Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.
Depression symptom severity measure
Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.
Psychache Scale
Time Frame: Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.
Depression symptom severity measure
Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.
Generalized Anxiety Disorder scale (GAD-7)
Time Frame: Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.
Self-reported anxiety measure
Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.
Satisfaction with Life Scale
Time Frame: Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.
Quality of life measure
Participants will be assessed at baseline, and assessed for changes immediately following the treatment and at 6 months and 12 months post treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christopher R Bowie, PhD, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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