Psychotic DisordersBOOSTNCT03491852
A Novel Treatment Approach for Self-Stigma in First Episode Psychosis
A study testing BOOST Intervention in people with Psychotic Disorders, run by Queen's University at 1 site in Canada.
Trial summary
Stigma towards mental illness is one of the greatest barriers to functional recovery that people with psychotic disorders face. Internalization of stigma (self-stigma) is associated with increased depressive symptoms, treatment non-adherence, and reduced quality of life. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- BOOST Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2018to Jan 2020
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Involvement in an early psychosis clinic for a period of less than 3 years, due to the focus of this study being on the treatment of early psychosis. Participants must be between the ages of 16 and 65 years. Participants 16 years of age who are incapable to consent without a parent or guardian will be excluded. Participants must be fluent in English, as determined by referring clinicians or researchers (in the case of advertisement referred participants) in order to meaningfully participate in the BOOST intervention and complete the assessment tools.
Who cannot join
- Potential participants who are unable to provide informed consent, as determined by the treatment team, will not be able to meaningfully participate in the BOOST intervention and will, therefore, be unable to participate in the research study. Individuals with a presence of intellectual disability or history of traumatic brain injury will also be excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton, West 5th Campus
Hamilton, Ontario, L8N 3K7
Elmar Gardizi, PhD, 905-522-1155 ext. 33883, egardizi@stjoes.ca
About this study
Official title: Be Outspoken and Overcome Stigmatizing Thoughts: A Randomized Controlled Trial Targeting Self-Stigma in First Episode Psychosis
Stigma towards mental illness is one of the greatest barriers to functional recovery that people with psychotic disorders face. Internalization of stigma (self-stigma) is associated with increased depressive symptoms, treatment non-adherence, and reduced quality of life. Self-stigma also has functional consequences, such as social avoidance and decreased help-seeking behaviour, which may worsen symptoms and impede recovery. Despite a growing awareness of the negative outcomes associated with self-stigma, few interventions have been designed to specifically address this experience in first episode psychosis. This project proposes to determine the effectiveness of an innovative, youth-oriented, group-based intervention known as Be Outspoken and Overcome Stigmatizing Thoughts (BOOST), which aims to reduce self-stigma and promote effective communication skills for adults (16-65 years old) experiencing a first episode of psychosis.
Read the detailed description
BOOST is a manualized intervention that combines psychoeducation and cognitive restructuring to replace stigmatizing views about early psychosis and help patients challenge negative self-evaluations. Assertiveness skills training is a unique component that was added to the group to empower individuals and provide them with the behavioural skills to fight back against self-stigma and get their needs met during social interactions.
Sessions are 60 minutes long and occur once a week for 8 weeks. Groups comprise 4-6 outpatients enrolled in a specialized outpatient clinic for early psychosis. Session are led by one therapist and co-facilitated with a peer support worker who has "lived experience" with early psychosis to provide unique insights on living with and overcoming self-stigma. The group format is informal and discussion-based, with an emphasis on sharing personal experiences.
Early sessions (1-4) focus on dispelling popular myths associated with psychosis and challenging erroneous beliefs, as a way to provide psychoeducation to patients. Additionally, time is spent identifying the impact of self-labelling, how this can lead to self-fulfilling prophecies, and getting participants to reflect on examples of when self-stigma might have behavioural consequences. Cognitive behavioural therapy techniques are used as a basis for the intervention, with an initial focus on cognitive restructuring to fight back against negative, stigmatizing thoughts.
Later sessions (5-8) target behavioural approaches for self-empowerment through assertiveness skills training and goal setting. Discussions are focused on the verbal and non-verbal characteristics of passive, aggressive, and assertive communication, in addition to techniques for speaking in an assertive manner. Role play scenarios that are specific to young people with psychosis provide opportunities to practice these skills in session. For example, Speaking up to a psychiatrist about the negative side effects of a medication or reaching out to a friend for support after returning from a hospitalization.
Weekly "missions" (i.e., home practice activities) are administered following each session to build on group content and help participants fight back against self-stigmatizing thoughts and attitudes in everyday contexts.
- Conditions
- Psychotic Disorders
- Being tested
- BOOST Intervention, Waitlist Control
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOOST InterventionBehavioural
A cognitive and behavioural group therapy designed to reduce self-stigma and promote effective communication skills for adults (16-65 years old) experiencing a first episode of psychosis.
Waitlist ControlBehavioural
Participants on the waitlist will still receive treatment as usual, which includes medical, psychosocial, and occupational interventions to help maximize patients' integration within the community and support recovery from a first episode of psychosis.
| Study group | Role | What they receive |
|---|---|---|
| BOOST Intervention | Experimental | The BOOST intervention consists of 8 group-based, weekly one-hour sessions. While every BOOST session is different, in general they will focus on helping participants fight back against stigmatizing thoughts and develop a sense of self-worth and empowerment. BOOST sessions are group-based and facilitated by trained clinicians, with the aid of a peer support worker to provide unique insights on living with and overcoming self-stigma. Content of sessions involve group discussions, exercises conducted in session, and between-session "missions" (i.e., home practice activities). Receives: Behavioral: BOOST Intervention |
| Waitlist Controls | Active comparator | Participants on the waitlist will still receive treatment as usual, which includes medical, psychosocial, and occupational interventions to help maximize patients' integration within the community and support recovery from a first episode of psychosis. Frequency of contact largely depends on the individual needs of patients. Waitlist controls will be offered the BOOST intervention 3 months post-enrollment. Receives: Behavioral: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Stigma - Internalized Stigma of Mental Illness Scale (ISMI) from Baseline
The ISMI (Ritsher, Otilingam, \& Grajales, 2003) is a 29-item self-report questionnaire designed to assess subjective experience of stigma.
Measured: Post-treatment (within 2 weeks following the end of treatment)
Secondary outcomes (7)
Change in Self-Esteem - Rosenberg Self-Esteem Scale (RSES) from Baseline
The RSES (Rosenberg et al., 1995) is a 10-item self-report questionnaire that IS used to measure self-esteem.
Measured: Post-treatment (within 2 weeks following the end of treatment)
Change in Quality of Life - Satisfaction with Life Safe (SWLS) from Baseline
The SWLS (Kobau et al., 2010) is a short 5-item instrument designed to measure global cognitive judgments of satisfactions with one's life.
Measured: Post-treatment (within 2 weeks following the end of treatment)
Change in Stigma Stress - Cognitive Appraisal of Stigma Stress (CogApp)
The CogApp (Rüsch et al., 2009) is an 8-item measure that yields a difference score of stigma stress by subtracting perceived resources to cope with stigma from perceived stigma-related harm.
Measured: Post-treatment (within 2 weeks following the end of treatment)
Change in Depression - Beck Depression Inventory-II (BDI)
The BDI-II (Beck, Steer, \& Brown, 1996) is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression.
Measured: Post-treatment (within 2 weeks following the end of treatment)
Change in Social Anxiety - Social Interaction Anxiety Scale (SIAS)
The SIAS (Mattick \& Clarke, 1998) is a 20 item self-report scale designed to measure social interaction anxiety.
Measured: Post-treatment (within 2 weeks following the end of treatment)
Change in Personal Recovery - Questionnaire about the Process of Recovery (QPR)
The QPR (Williams et al., 2015) is a 22-item, service user-rated measure of personal recovery.
Measured: Post-treatment (within 2 weeks following the end of treatment)
Change in Functioning - Sheehan Disability Scale (SDS)
The SDS (Sheehan et al., 1996) is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.
Measured: Post-treatment (within 2 weeks following the end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Apr 2018
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Principal investigator, Dr. Christopher Bowie, Queen's University
- Investigators
- Christopher Bowie, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491852
- Sponsor's protocol ID
- 4077
- Acronym
- BOOST
- Status last verified
- Aug 2018
- First submitted
- 2 Apr 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Be Outspoken and Overcome Stigmatizing Thoughts: A Randomized Controlled Trial Targeting Self-Stigma in First Episode Psychosis
- ClinicalTrials.gov ID
- NCT03491852
- Acronym / sponsor ID
- BOOST / 4077
- Conditions
- Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stigma towards mental illness is one of the greatest barriers to functional recovery that people with psychotic disorders face. Internalization of stigma (self-stigma) is associated with increased depressive symptoms, treatment non-adherence, and reduced quality of life. Self-stigma also has functional consequences, such as social avoidance and decreased help-seeking behaviour, which may worsen symptoms and impede recovery. Despite a growing awareness of the negative outcomes associated with self-stigma, few interventions have been designed to specifically address this experience in first episode psychosis. This project proposes to determine the effectiveness of an innovative, youth-oriented, group-based intervention known as Be Outspoken and Overcome Stigmatizing Thoughts (BOOST), which aims to reduce self-stigma and promote effective communication skills for adults (16-65 years old) experiencing a first episode of psychosis.
Detailed description
BOOST is a manualized intervention that combines psychoeducation and cognitive restructuring to replace stigmatizing views about early psychosis and help patients challenge negative self-evaluations. Assertiveness skills training is a unique component that was added to the group to empower individuals and provide them with the behavioural skills to fight back against self-stigma and get their needs met during social interactions.
Sessions are 60 minutes long and occur once a week for 8 weeks. Groups comprise 4-6 outpatients enrolled in a specialized outpatient clinic for early psychosis. Session are led by one therapist and co-facilitated with a peer support worker who has "lived experience" with early psychosis to provide unique insights on living with and overcoming self-stigma. The group format is informal and discussion-based, with an emphasis on sharing personal experiences.
Early sessions (1-4) focus on dispelling popular myths associated with psychosis and challenging erroneous beliefs, as a way to provide psychoeducation to patients. Additionally, time is spent identifying the impact of self-labelling, how this can lead to self-fulfilling prophecies, and getting participants to reflect on examples of when self-stigma might have behavioural consequences. Cognitive behavioural therapy techniques are used as a basis for the intervention, with an initial focus on cognitive restructuring to fight back against negative, stigmatizing thoughts.
Later sessions (5-8) target behavioural approaches for self-empowerment through assertiveness skills training and goal setting. Discussions are focused on the verbal and non-verbal characteristics of passive, aggressive, and assertive communication, in addition to techniques for speaking in an assertive manner. Role play scenarios that are specific to young people with psychosis provide opportunities to practice these skills in session. For example, Speaking up to a psychiatrist about the negative side effects of a medication or reaching out to a friend for support after returning from a hospitalization.
Weekly "missions" (i.e., home practice activities) are administered following each session to build on group content and help participants fight back against self-stigmatizing thoughts and attitudes in everyday contexts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOOST Intervention | Experimental | Behavioral: BOOST InterventionThe BOOST intervention consists of 8 group-based, weekly one-hour sessions. While every BOOST session is different, in general they will focus on helping participants fight back against stigmatizing thoughts and develop a sense of self-worth and empowerment. BOOST sessions are group-based and facilitated by trained clinicians, with the aid of a peer support worker to provide unique insights on living with and overcoming self-stigma. Content of sessions involve group discussions, exercises conducted in session, and between-session "missions" (i.e., home practice activities). |
| Waitlist Controls | Active comparator | Behavioral: Waitlist ControlParticipants on the waitlist will still receive treatment as usual, which includes medical, psychosocial, and occupational interventions to help maximize patients' integration within the community and support recovery from a first episode of psychosis. Frequency of contact largely depends on the individual needs of patients. Waitlist controls will be offered the BOOST intervention 3 months post-enrollment. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Involvement in an early psychosis clinic for a period of less than 3 years, due to the focus of this study being on the treatment of early psychosis. Participants must be between the ages of 16 and 65 years. Participants 16 years of age who are incapable to consent without a parent or guardian will be excluded. Participants must be fluent in English, as determined by referring clinicians or researchers (in the case of advertisement referred participants) in order to meaningfully participate in the BOOST intervention and complete the assessment tools.
Key exclusion criteria (1 listed)
- Potential participants who are unable to provide informed consent, as determined by the treatment team, will not be able to meaningfully participate in the BOOST intervention and will, therefore, be unable to participate in the research study. Individuals with a presence of intellectual disability or history of traumatic brain injury will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOOST InterventionA cognitive and behavioural group therapy designed to reduce self-stigma and promote effective communication skills for adults (16-65 years old) experiencing a first episode of psychosis. | Behavioural | BOOST Intervention |
| Waitlist ControlParticipants on the waitlist will still receive treatment as usual, which includes medical, psychosocial, and occupational interventions to help maximize patients' integration within the community and support recovery from a first episode of psychosis. | Behavioural | Waitlist Controls |
Primary outcome
Change in Self-Stigma - Internalized Stigma of Mental Illness Scale (ISMI) from Baseline
Time frame: Post-treatment (within 2 weeks following the end of treatment)
The ISMI (Ritsher, Otilingam, \& Grajales, 2003) is a 29-item self-report questionnaire designed to assess subjective experience of stigma.
7 secondary outcomes
Change in Self-Esteem - Rosenberg Self-Esteem Scale (RSES) from Baseline
Time frame: Post-treatment (within 2 weeks following the end of treatment)
Change in Quality of Life - Satisfaction with Life Safe (SWLS) from Baseline
Time frame: Post-treatment (within 2 weeks following the end of treatment)
Change in Stigma Stress - Cognitive Appraisal of Stigma Stress (CogApp)
Time frame: Post-treatment (within 2 weeks following the end of treatment)
Change in Depression - Beck Depression Inventory-II (BDI)
Time frame: Post-treatment (within 2 weeks following the end of treatment)
Change in Social Anxiety - Social Interaction Anxiety Scale (SIAS)
Time frame: Post-treatment (within 2 weeks following the end of treatment)
Change in Personal Recovery - Questionnaire about the Process of Recovery (QPR)
Time frame: Post-treatment (within 2 weeks following the end of treatment)
Change in Functioning - Sheehan Disability Scale (SDS)
Time frame: Post-treatment (within 2 weeks following the end of treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Psychotic Disorders
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
Recruiting
REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Schizophrenia, Schizo Affective Disorder
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
Psychotic Disorders, Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Bowie, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BOOST Intervention in people with Psychotic Disorders, 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 1 inclusion and 1 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 28 Aug 2018. 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?
Contact Michael Grossman, MA (1-877-669-8510 ext. 106, michael.grossman@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Stigma - Internalized Stigma of Mental Illness Scale (ISMI) from Baseline (time frame: Post-treatment (within 2 weeks following the end of 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 28 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.