Evaluation the Impact of Self-Stigma Reduction Program on Psychosocial Outcomes Among People Diagnosed With Schizophrenia
1 other identifier
interventional
278
1 country
1
Brief Summary
Backgrounds: Research evidence suggests that people diagnosed with schizophrenia (PDwS) experience higher level of stigma compared with other forms of mental illness, and they are prone to internalize stereotype, which exacerbates severity of psychiatric symptoms, reduces their psychosocial treatment adherence. The purpose of the study to evaluate the effectiveness of stigma reduction program on the perceived stigma, psychiatric symptoms, compliance with psychosocial intervention and self-efficacy. Methods: A randomized controlled trial was conducted from November 2017 to December 2018 with 278 PDwS. Participants aged 18 years or older with DSM-IV schizophrenia or schizoaffective disorder, from four outpatient mental health clinics in Jordan, were randomly assigned to receive 13 sessions of a booklet form of stigma reduction program (n = 140) (psycho-education, cognitive behavioural therapy and social skills training), and treatment as usual \[TAU\] (intervention, n = 140), or TAU (control, n = 138). Participants were assessed at baseline, immediately post-intervention (post-treatment1) and at six months follow-up. The primary outcome measure was change in stigma perception. Secondary outcomes were psychiatric symptoms, compliance with psychosocial interventions and self-efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2018
CompletedFirst Submitted
Initial submission to the registry
September 7, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedSeptember 12, 2019
September 1, 2019
1.1 years
September 7, 2019
September 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The primary outcome was stigma perception measured by the Internalised Stigma of Mental Illness Scale (ISMI)
The primary outcome was stigma perception measured by the Internalised Stigma of Mental Illness Scale (ISMI). This scale has 29 items measure service user experience of stigma. It is composed of 5 subscales: alienation (6 items), stereotype endorsement (7 items), discrimination experience (5 items), social withdrawal (6 items), and stigma resistance (5 items). Each item is rated on a four-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). The five stigma resistance subscale items are reverse-coded, and also serve as a validity check. The stigma resistance score is calculated by subtracting the actual value from five. Therefore, stigma resistance displays the same direction of correlation as the other four subscales. A high total score on the ISMI scale indicates more severe internalized stigmatization. The internal consistency is (α=0.90) and test-retest reliability (r=0.92) have been reported for the ISMI (Ritsher \& Phelan, 2004).
November 2017-December 2018 (up to 11 months)
Secondary Outcomes (3)
Positive and Negative Symptom Scale (PANSS)
November 2017-December 2018 (up to 11 months)
The Psychosocial Treatment Compliance Scale (PTCS)
November 2017-December 2018 (up to 11 months)
The Chinese General Self-efficacy Scale (CGSS)
November 2017-December 2018 (up to 11 months)
Study Arms (2)
Intervention vs control
EXPERIMENTALControl
NO INTERVENTIONInterventions
Participants in the intervention group received treatment as usual, supported with stigma reduction program booklets each fortnight for 26 weeks. The stigma reduction program includes three modules; psychoeducation, cognitive behavioural therapy and social skills training. The program aims to enhance patient understanding of Schizophrenia and foster communication skills which supposed to increase self-confidence and strengthen communication networking with society. Psychoeducation module purposes at introducing about the concepts of schizophrenia, providing patient with essential information about schizophrenia, including nature of disease, sign/symptoms, treatment strategies, side effects of medication. Social Skills Training (SST) module purposes at fostering communication skills among patient diagnosed with schizophrenia. This assists the participants to be re-integrated in the society and build a harmonious atmosphere in the community.
Eligibility Criteria
You may not qualify if:
- \- People diagnosed with schizophrenia who had a learning disability, with known organic mental disorder, substance abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ministry of Health
Amman, 00962, Jordan
Related Publications (1)
Hasan AA, Alasmee N. Evaluation of the impact of a self-stigma reduction programme on psychosocial outcomes among people with schizophrenia spectrum disorder. J Ment Health. 2022 Feb;31(1):83-91. doi: 10.1080/09638237.2021.1922628. Epub 2021 Sep 14.
PMID: 34517747DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
September 7, 2019
First Posted
September 12, 2019
Study Start
November 1, 2017
Primary Completion
December 22, 2018
Study Completion
December 22, 2018
Last Updated
September 12, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share