Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05571228 |
| Other study ID # |
PSYC-242-20 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Queen's University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
