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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03491852
• Date of registration: 02/04/2018
• Prospective Registration: No
• Primary sponsor: Queen's University
• Public title: A Novel Treatment Approach for Self-Stigma in First Episode Psychosis BOOST
• Scientific title: Be Outspoken and Overcome Stigmatizing Thoughts: A Randomized Controlled Trial Targeting Self-Stigma in First Episode Psychosis
• Date of first enrolment: April 1, 2018
• Target sample size: 40
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03491852
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Elmar Gardizi, PhD

• Name: Michael Grossman, MA

• Name: Christopher Bowie, PhD
• Affiliation: Queen's University

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Psychotic Disorders

Intervention(s)

Behavioral: BOOST Intervention

Behavioral: Waitlist Control

Primary Outcome(s)

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)]

Secondary Outcome(s)

Change in Depression - Beck Depression Inventory-II (BDI) [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 Functioning - Sheehan Disability Scale (SDS) [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 Self-Esteem - Rosenberg Self-Esteem Scale (RSES) from Baseline [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 Stigma Stress - Cognitive Appraisal of Stigma Stress (CogApp) [Time Frame: Post-treatment (within 2 weeks following the end of treatment)]

Secondary ID(s)

4077

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St. Joseph's Healthcare Hamilton