Evaluation the Impact of Self-Stigma Reduction Program on Psychosocial Outcomes Among People Diagnosed With Schizophrenia

Stigmatization Clinical Trial

Official title:

Evaluation the Impact of Self-Stigma Reduction Program on Psychosocial Outcomes Among People Diagnosed With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087954
• Other study ID #: 5115
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 22, 2018

Study information

• Verified date: September 2019
• Source: Fakeeh College for Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: December 22, 2018
• Est. primary completion date: December 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Eligibility Criteria

• Adults aged 18 or over diagnosed with schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) (American Psychiatric Association, 2013).

• All participants had to be able to read and write English or Arabic

• Willing and able to consent.

Exclusion criteria were:

• People diagnosed with schizophrenia who had a learning disability, with known organic mental disorder, substance abuse

Related Conditions & MeSH terms

• Schizophrenia
• Stigmatization

Intervention

Behavioral:
• Stigma reduction program
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.

Locations

Country	Name	City	State
Jordan	Ministry of Health	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Fakeeh College for Medical Sciences

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (a=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	Positive and Negative Symptom Scale (PANSS)	PANSS measures 30 clinical symptoms of schizophrenia; each symptom is scored from 1 indicating absence of psychopathology to 7 indicating severe psychopathology, with higher scores indicating poorer mental health status. Internal reliability and criterion-related validity are 0.77 (positive scale) and 0.77 (negative scale), and 0.52 with the Clinical Global Impression scale (CGI) (Kay, Fiszbein, & Opfer, 1987). The primary researcher (AH) attended training delivered by the PANSS Institute, USA, and trained the outcomes assessors. An inter-rater reliability checked prior to the study, between assessors was 0.75 and inter-rater reliability (intra-class correlation (ICC) was 0.79. This tool was administered in English by the primary researcher (AH) and research assistants.	November 2017-December 2018 (up to 11 months)
Secondary	The Psychosocial Treatment Compliance Scale (PTCS)	The Psychosocial Treatment Compliance Scale (PTCS) (Tsang et al., 2006) has 17 items rated from "(1) never" to "(5) always". The PTCS has the "participation" (12 items) and "attendance" (5 items) subscales. The scale has two main parts, participation which indicates the level of participants engagement and participation in the psychosocial interventions (e.g., "was willing to follow therapists' instructions"). However, attendance measures that participants commitment to scheduled appointments (e.g., "attended prescribed psychosocial treatment on time"). The scale has good psychometric properties (internal consistency: a=.87-.96; test-retest reliability: ICC=.86-.90) were demonstrated for the subscales (Tsang et al., 2006).	November 2017-December 2018 (up to 11 months)
Secondary	The Chinese General Self-efficacy Scale (CGSS)	The Chinese General Self-efficacy Scale (CGSS) developed by (Chiu & Tsang, 2004). This scale has a 10-item. Scoring system ranges from "(1) Not at all true" to "(4) Exactly true". Participants with higher score reflect better general self-efficacy. The CGSS demonstrated good internal consistency (a=0.92-0.93) and test-retest reliability (ICC=0.75-0.94) (Chiu & Tsang, 2004).	November 2017-December 2018 (up to 11 months)