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Clinical Trials/NCT03491852
NCT03491852
Unknown
N/A

Be Outspoken and Overcome Stigmatizing Thoughts: A Randomized Controlled Trial Targeting Self-Stigma in First Episode Psychosis

Queen's University1 site in 1 country40 target enrollmentApril 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychotic Disorders
Sponsor
Queen's University
Enrollment
40
Locations
1
Primary Endpoint
Change in Self-Stigma - Internalized Stigma of Mental Illness Scale (ISMI) from Baseline
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
January 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Christopher Bowie

Principal Investigator, Professor, Deptartment of Psychology, Queen's University

Queen's University

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Change in Functioning - Sheehan Disability Scale (SDS)(Post-treatment (within 2 weeks following the end of treatment))
  • Change in Depression - Beck Depression Inventory-II (BDI)(Post-treatment (within 2 weeks following the end of treatment))
  • Change in Personal Recovery - Questionnaire about the Process of Recovery (QPR)(Post-treatment (within 2 weeks following the end of treatment))
  • Change in Quality of Life - Satisfaction with Life Safe (SWLS) from Baseline(Post-treatment (within 2 weeks following the end of treatment))
  • Change in Social Anxiety - Social Interaction Anxiety Scale (SIAS)(Post-treatment (within 2 weeks following the end of treatment))
  • Change in Self-Esteem - Rosenberg Self-Esteem Scale (RSES) from Baseline(Post-treatment (within 2 weeks following the end of treatment))
  • Change in Stigma Stress - Cognitive Appraisal of Stigma Stress (CogApp)(Post-treatment (within 2 weeks following the end of treatment))

Study Sites (1)

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