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

Primary Purpose

Stigmatization

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Stigma reduction program
Sponsored by
Fakeeh College for Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stigmatization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ministry of Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention vs control

Control

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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: α=.87-.96; test-retest reliability: ICC=.86-.90) were demonstrated for the subscales (Tsang et al., 2006).
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 (α=0.92-0.93) and test-retest reliability (ICC=0.75-0.94) (Chiu & Tsang, 2004).

Full Information

First Posted
September 7, 2019
Last Updated
September 10, 2019
Sponsor
Fakeeh College for Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04087954
Brief Title
Evaluation the Impact of Self-Stigma Reduction Program on Psychosocial Outcomes Among People Diagnosed With Schizophrenia
Official Title
Evaluation the Impact of Self-Stigma Reduction Program on Psychosocial Outcomes Among People Diagnosed With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 22, 2018 (Actual)
Study Completion Date
December 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fakeeh College for Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stigmatization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention vs control
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Stigma reduction program
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome was stigma perception measured by the Internalised Stigma of Mental Illness Scale (ISMI)
Description
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).
Time Frame
November 2017-December 2018 (up to 11 months)
Secondary Outcome Measure Information:
Title
Positive and Negative Symptom Scale (PANSS)
Description
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.
Time Frame
November 2017-December 2018 (up to 11 months)
Title
The Psychosocial Treatment Compliance Scale (PTCS)
Description
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: α=.87-.96; test-retest reliability: ICC=.86-.90) were demonstrated for the subscales (Tsang et al., 2006).
Time Frame
November 2017-December 2018 (up to 11 months)
Title
The Chinese General Self-efficacy Scale (CGSS)
Description
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 (α=0.92-0.93) and test-retest reliability (ICC=0.75-0.94) (Chiu & Tsang, 2004).
Time Frame
November 2017-December 2018 (up to 11 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ministry of Health
City
Amman
ZIP/Postal Code
00962
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34517747
Citation
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.
Results Reference
derived

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

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