A Novel Treatment Approach for Self-Stigma in First Episode Psychosis (BOOST)
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|ClinicalTrials.gov Identifier: NCT03491852|
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Psychotic Disorders||Behavioral: BOOST Intervention Behavioral: Waitlist Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Be Outspoken and Overcome Stigmatizing Thoughts: A Randomized Controlled Trial Targeting Self-Stigma in First Episode Psychosis|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
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).
Behavioral: 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.
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.
Behavioral: Waitlist Control
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.
- 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.
- Change in Self-Esteem - Rosenberg Self-Esteem Scale (RSES) from Baseline [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]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 [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]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) [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]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) [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]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) [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]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) [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]The QPR (Williams et al., 2015) is a 22-item, service user-rated measure of personal recovery.
- Change in Functioning - Sheehan Disability Scale (SDS) [ Time Frame: Post-treatment (within 2 weeks following the end of treatment) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491852
|Contact: Michael Grossman, MA||1-877-669-8510 ext firstname.lastname@example.org|
|Contact: Michael Best, MSc||1-877-669-8510 ext email@example.com|
|St. Joseph's Healthcare Hamilton, West 5th Campus||Recruiting|
|Hamilton, Ontario, Canada, L8N 3K7|
|Contact: Elmar Gardizi, PhD 905-522-1155 ext 33883 firstname.lastname@example.org|
|Principal Investigator:||Christopher Bowie, PhD||Queen's University|