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SchizophreniaNCT05571228

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

A study testing Self-stigma intervention in people with Schizophrenia and Psychosis, run by Queen's University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Schizophrenia, Psychosis
What is being tested?
Self-stigma intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
1 Oct 2020to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Queen's University

    Kingston, Ontario, K7L 3J9

Other trials in Canada

About this study

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.

Being tested
Self-stigma intervention
Keywords
Early Psychosis, Remote treatment
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-stigma interventionBehavioural

    Also called Be Outspoken and Overcome Stigmatizing Thoughts (BOOST)

    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.

Study groups in NCT05571228
Study groupRoleWhat they receive
Internalized stigma groupExperimentalBOOST 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.
Receives: Behavioral: Self-stigma intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Self-Injurious Thoughts and Behaviours Interview Self-Report

    Cognition associated with risk of suicide

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2022
  2. Study start1 Oct 2020
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05571228
Sponsor's protocol ID
PSYC-242-20
Status last verified
Nov 2023
First submitted
17 Jan 2022
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Self-stigma intervention in people with Schizophrenia and Psychosis, run by Queen's University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.

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