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

Primary Purpose

Psychotic Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
BOOST Intervention
Waitlist Control
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Joseph's Healthcare Hamilton, West 5th CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BOOST Intervention

Waitlist Controls

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 2, 2018
Last Updated
August 27, 2018
Sponsor
Queen's University
Collaborators
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT03491852
Brief Title
A Novel Treatment Approach for Self-Stigma in First Episode Psychosis
Acronym
BOOST
Official Title
Be Outspoken and Overcome Stigmatizing Thoughts: A Randomized Controlled Trial Targeting Self-Stigma in First Episode Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
St. Joseph's Healthcare Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BOOST Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Waitlist Controls
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BOOST Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist Control
Intervention Description
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 Measure Information:
Title
Change in Self-Stigma - Internalized Stigma of Mental Illness Scale (ISMI) from Baseline
Description
The ISMI (Ritsher, Otilingam, & Grajales, 2003) is a 29-item self-report questionnaire designed to assess subjective experience of stigma.
Time Frame
Post-treatment (within 2 weeks following the end of treatment)
Secondary Outcome Measure Information:
Title
Change in Self-Esteem - Rosenberg Self-Esteem Scale (RSES) from Baseline
Description
The RSES (Rosenberg et al., 1995) is a 10-item self-report questionnaire that IS used to measure self-esteem.
Time Frame
Post-treatment (within 2 weeks following the end of treatment)
Title
Change in Quality of Life - Satisfaction with Life Safe (SWLS) from Baseline
Description
The SWLS (Kobau et al., 2010) is a short 5-item instrument designed to measure global cognitive judgments of satisfactions with one's life.
Time Frame
Post-treatment (within 2 weeks following the end of treatment)
Title
Change in Stigma Stress - Cognitive Appraisal of Stigma Stress (CogApp)
Description
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.
Time Frame
Post-treatment (within 2 weeks following the end of treatment)
Title
Change in Depression - Beck Depression Inventory-II (BDI)
Description
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.
Time Frame
Post-treatment (within 2 weeks following the end of treatment)
Title
Change in Social Anxiety - Social Interaction Anxiety Scale (SIAS)
Description
The SIAS (Mattick & Clarke, 1998) is a 20 item self-report scale designed to measure social interaction anxiety.
Time Frame
Post-treatment (within 2 weeks following the end of treatment)
Title
Change in Personal Recovery - Questionnaire about the Process of Recovery (QPR)
Description
The QPR (Williams et al., 2015) is a 22-item, service user-rated measure of personal recovery.
Time Frame
Post-treatment (within 2 weeks following the end of treatment)
Title
Change in Functioning - Sheehan Disability Scale (SDS)
Description
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.
Time Frame
Post-treatment (within 2 weeks following the end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Grossman, MA
Phone
1-877-669-8510
Ext
106
Email
michael.grossman@queensu.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Best, MSc
Phone
1-877-669-8510
Ext
105
Email
best.m@queensu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Bowie, PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton, West 5th Campus
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3K7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elmar Gardizi, PhD
Phone
905-522-1155
Ext
33883
Email
egardizi@stjoes.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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