Clinical trial NCT03197168: Psychosocial Intervention to Reduce Self-stigma and Improve Quality of Life Among People With Mental Illness in Chile
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Schizoaffective Disorder
Keywords: stigma
psychosocial intervention
low-and-middle income countries
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Chile
First posted: 2017-06-23
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Self-stigma
timeFrame: 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 outcomes:
measure: Quality of Life
timeFrame: 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)
measure: Psychopathology
timeFrame: 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)
measure: Treatment adherence
timeFrame: 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)
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: University of Chile
state: Metropolitana
Study officials:
References:
citation: 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 Nac Cordoba. 2015;72(4):284-94.