Clinical trial NCT04087954: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stigmatization
Lead sponsor: Fakeeh College for Medical Sciences
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: The primary outcome was stigma perception measured by the Internalised Stigma of Mental Illness Scale (ISMI)
timeFrame: November 2017-December 2018 (up to 11 months)
Secondary outcomes:
measure: Positive and Negative Symptom Scale (PANSS)
timeFrame: November 2017-December 2018 (up to 11 months)
measure: The Psychosocial Treatment Compliance Scale (PTCS)
timeFrame: November 2017-December 2018 (up to 11 months)
measure: The Chinese General Self-efficacy Scale (CGSS)
timeFrame: November 2017-December 2018 (up to 11 months)
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Ministry of Health
Study officials:
References:
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.