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A Novel Treatment Approach for Self-Stigma in First Episode Psychosis (BOOST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491852
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
Dr. Christopher Bowie, Queen's University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Behavioral: BOOST Intervention Behavioral: Waitlist Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Be Outspoken and Overcome Stigmatizing Thoughts: A Randomized Controlled Trial Targeting Self-Stigma in First Episode Psychosis
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BOOST Intervention
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).
Behavioral: BOOST Intervention
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.

Active Comparator: Waitlist Controls
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.
Behavioral: Waitlist Control
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Self-Esteem - Rosenberg Self-Esteem Scale (RSES) from Baseline [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]
    The RSES (Rosenberg et al., 1995) is a 10-item self-report questionnaire that IS used to measure self-esteem.

  2. Change in Quality of Life - Satisfaction with Life Safe (SWLS) from Baseline [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]
    The SWLS (Kobau et al., 2010) is a short 5-item instrument designed to measure global cognitive judgments of satisfactions with one's life.

  3. Change in Stigma Stress - Cognitive Appraisal of Stigma Stress (CogApp) [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]
    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.

  4. Change in Depression - Beck Depression Inventory-II (BDI) [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]
    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.

  5. Change in Social Anxiety - Social Interaction Anxiety Scale (SIAS) [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]
    The SIAS (Mattick & Clarke, 1998) is a 20 item self-report scale designed to measure social interaction anxiety.

  6. Change in Personal Recovery - Questionnaire about the Process of Recovery (QPR) [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]
    The QPR (Williams et al., 2015) is a 22-item, service user-rated measure of personal recovery.

  7. Change in Functioning - Sheehan Disability Scale (SDS) [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491852


Contacts
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Contact: Michael Grossman, MA 1-877-669-8510 ext 106 michael.grossman@queensu.ca
Contact: Michael Best, MSc 1-877-669-8510 ext 105 best.m@queensu.ca

Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton, West 5th Campus Recruiting
Hamilton, Ontario, Canada, L8N 3K7
Contact: Elmar Gardizi, PhD    905-522-1155 ext 33883    egardizi@stjoes.ca   
Sponsors and Collaborators
Queen's University
St. Joseph's Healthcare Hamilton
Investigators
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Principal Investigator: Christopher Bowie, PhD Queen's University

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Responsible Party: Dr. Christopher Bowie, Principal Investigator, Professor, Deptartment of Psychology, Queen's University, Queen's University
ClinicalTrials.gov Identifier: NCT03491852    
Other Study ID Numbers: 4077
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders