NCT04087954

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

September 7, 2019

Last Update Submit

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

EXPERIMENTAL
Behavioral: Stigma reduction program

Control

NO INTERVENTION

Interventions

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.

Intervention vs control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Stereotyping

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

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

Locations