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

NCT03491852 | Unknown

• 1 other identifier: 4077
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  Post-treatment (within 2 weeks following the end of treatment)

Secondary Outcomes (7)

• Change in Self-Esteem - Rosenberg Self-Esteem Scale (RSES) from Baseline

  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 Stigma Stress - Cognitive Appraisal of Stigma Stress (CogApp)

  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 Social Anxiety - Social Interaction Anxiety Scale (SIAS)

  Post-treatment (within 2 weeks following the end of treatment)

Study Arms (2)

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).

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.

Behavioral: Waitlist Control

Interventions

BOOST Intervention BEHAVIORAL

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.

BOOST Intervention

Waitlist Control BEHAVIORAL

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.

Waitlist Controls

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton, West 5th Campus

Hamilton, Ontario, L8N 3K7, Canada

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Christopher Bowie, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Grossman, MA

CONTACT

1-877-669-8510; michael.grossman@queensu.ca

Michael Best, MSc

CONTACT

1-877-669-8510; best.m@queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor, Deptartment of Psychology, Queen's University

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 9, 2018
• Study Start: April 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)