Psychosocial Intervention to Reduce Self-stigma and Improve Quality of Life Among People With Mental Illness in Chile

Schizophrenia Clinical Trial

Official title:

Implementing a Psychosocial Intervention to Reduce Self-stigma and Improve Quality of Life Among Mental Health Outpatients in Chile: a Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197168
• Other study ID #: SA13I20384
• Status: Completed
• Phase: N/A
• First received: September 1, 2016
• Last updated: June 22, 2017
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: June 2017
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The principal objective of this pilot trial is to evaluate the effectiveness of a psychosocial intervention to reduce self-stigma and improve treatment adherence and quality of life among people with a severe mental illness who attend to Community Mental Health Centers in Chile. The intervention is based on recovery and narrative therapy and considers 10 group sessions, mainly with patients, but also integrating relatives and professionals in some of the activities.

Description:

It has been shown that stigma is one of the main barriers faced by individuals with mental illness, negatively impacting their service use and continuity of treatment. Additionally, given its impact on self-esteem, personal empowerment, and social inclusion, stigma greatly affects the quality of life of this population.

Consequently, a pilot randomized controlled trial (RCT) with two arms (intervention group vs. control group) was designed and implemented. Participants were identified and recruited from two community mental health centers located in Central Chile. The intervention group, in addition to usual care, received a psychosocial intervention based on narrative therapy, recovery and psychoeducation which was specially tailored for this population by the authors.

The sample corresponds to 76 individuals with a severe mental illness (ICD-10), currently treated in the two participating Community Mental Health Centers (COSAM). The category "severe mental illness" includes patients with diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder and severe depressive disorder with psychotic symptoms. Finally, those two clinics were chosen by convenience in order to facilitate the implementation of this study.

Before and after the intervention, the participants' self-stigma (Internalized Stigma of Mental Illness, ISMI), treatment adherence (weeks in treatment), and quality of life (Sevilla Quality of Life Scale) were measured. In addition, the following control variables were also evaluated, due to their influence on the principal outcomes: 1) sociodemographic information, 2) symptom presence and severity (Positive and Negative Syndrome Scale, PANSS), and 3) alcohol consumption (The Alcohol Use Disorders Identification Test, AUDIT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• People with diagnosis of severe mental illness, including the following ICD-10 disorders: schizophrenia, schizoaffective disorder, bipolar disorder, severe depressive episode with psychotic symptoms.

• No longer than 5 years since the diagnosis since the first visit to a mental health clinic.

Exclusion Criteria:

• Expressing active suicidal ideation.

• Having substance abuse or dependence alone (may have psychotic symptoms but does not meet criteria for diagnoses included).

• Presenting cognitive or other sensorial impairment which is likely to preclude reliable assessment via our interview procedures

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Intervention to reduce self-stigma among people with mental illness
This is a 10-session group intervention (held once a week), each lasting approximately 90 minutes, taking place where the participants receive mental health treatment. The intervention is informed by the following key areas: (1) recovery perspective of mental health and severe mental disorders; (2) constructivist epistemology approach to learning, using cases and users' experiences; and (3) psychotherapeutic and collective narrative practices, to address internalized problems and challenges shared among the group members, respectively.
• Control
Generally, each community mental health center in Chile includes two full-time psychologists, a full-time social worker and half-time occupational therapist, nurse, and psychiatrist. This team mainly offers psychiatric medication, psychotherapy, and psycho-education for users and relatives. They do not offer any specific intervention to tackle stigma among providers.

Locations

Country	Name	City	State
Chile	University of Chile	Santiago	Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Ministry of Health, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (1)

Schilling S, Bustamante JA, Sala A, Acevedo C, Tapia E, Alvarado R, Sapag JC, Yang LH, Lukens E, Mascayano F, Cid P, Tapia T. Development of an intervention to reduce self-stigma in outpatient mental health service users in Chile. Rev Fac Cien Med Univ Na — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-stigma	Internalized Stigma of Mental Illness Scale (ISMI) (Rishter et al., 2003). A Chilean version of this instrument was used during the study.	Baseline (month 6); First follow-up assessment (change from Baseline ISMI scores at month 10); Second follow-up assessment (change from Baseline and 1st follow-up ISMI scores at month 14)
Secondary	Quality of Life	Seville Quality of Life Questionnaire (CSCV) (Gómez de Regil, 2016). A Chilean version of this instrument was used during the study.	Baseline (month 6); First follow-up assessment (change from Baseline CSCV scores at month 10); Second follow-up assessment (change from Baseline and 1st follow-up CSCV scores at month 14)
Secondary	Psychopathology	Positive and Negative Syndrome Scale (PANSS). A Chilean version of this instrument was used during the study.	Baseline (month 6); First follow-up assessment (chance from Baseline PANSS scores at month 10); Second follow-up assessment (change from Baseline and 1st follow-up PANSS scores at month 14)
Secondary	Treatment adherence	Adherence to medical appointments during the study. Time remaining in treatment is estimated by counting the number of days between randomization to the time of the last mental health service received. Medical records at each community mental health center are reviewed to obtain this data.	Baseline (month 6); First follow-up assessment (change from Treatment Adherence Baseline at month 10); Second follow-up assessment (change from Treatment Adherence Baseline and 1st follow-up at month 14)

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