Recruiting

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

Sponsor:

Queen's University

Code:

NCT03491852

Conditions

Psychotic Disorders

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

Interventions

BOOST Intervention

Waitlist Control

Study Details

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

Study ID

NCT03491852

Start date

Apr 1, 2018

Status verified date

Aug, 2018

Completion date

Jan, 2020

Anticipated

Primary completion date

Jan, 2020

Anticipated

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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.

Interventions

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.

Waitlist Control

Primary outcome measure

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) ]

Central Contacts and Locations

Central contacts

Michael Grossman, MA

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

Michael Best, MSc

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

Locations

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

Recruiting

Hamilton, Ontario, Canada, L8N 3K7

Contacts

Elmar Gardizi, PhD

905-522-1155 egardizi@stjoes.ca

More Information

Sponsor

Queen's University

Last update posted

Aug 28, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's University on 2018-08-28.