ClinicalTrials.gg
Status unknownNCT05571228Updated Nov 15, 2023

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

An interventional study of Self-stigma intervention in Schizophrenia and Psychosis, sponsored by Queen's University. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-11-15.

Sponsored by Queen's University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Oct 2020, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Schizophrenia
  • Psychosis

Keywords

  • Early Psychosis
  • Remote treatment
03

In context

Schizophrenia

3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 2,924 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Queen's University is the lead sponsor of 207 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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.

    Behavioral: Self-stigma intervention

Interventions

  • BehavioralSelf-stigma intervention

    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)

06

What researchers measure

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.

    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.

Secondary outcomes

  1. Self-Injurious Thoughts and Behaviours Interview Self-Report

    Cognition associated with risk of suicide

    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.

  2. Interpersonal Hopelessness Scale

    Cognition associated with hopelessness

    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.

  3. Interpersonal Needs Questionnaire

    Interpersonal needs measure

    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.

  4. Rosenberg Self-Esteem Scale

    Self-esteem measure

    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.

  5. Patient Health Questionnaire

    Depression symptom severity measure

    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.

  6. Psychache Scale

    Depression symptom severity measure

    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.

  7. Generalized Anxiety Disorder scale (GAD-7)

    Self-reported anxiety measure

    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.

  8. Satisfaction with Life Scale

    Quality of life measure

    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.

07

Study locations

1 site
  • Queen's University
    Kingston, Ontario K7L 3J9, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2020 (actual). Primary completion is estimated for Dec 2023, 38 months after the start.

Of 755 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 38 months is above that.

Counting every sponsor, half of 768 studies reached it within 32 months; a quarter within 16 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2022
First posted
Oct 7, 2022
StartActual
Oct 1, 2020
Primary completionEst.
Dec 31, 2023
CompletionEst.
Dec 31, 2024
Last update
Nov 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05571228
Lead sponsor
Queen's University
Responsible party
Dr. Christopher Bowie (Professor and Director of Clinical Training Department with the Psychology, Queen's University) — Principal investigator
First posted
Oct 7, 2022
Start date
Oct 1, 2020
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Nov 15, 2023

Study contacts

Christopher R Bowie, PhD
principal investigator · Queen's University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion