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
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.
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).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
| Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
| Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
| Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
| Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
| Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
| Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
| Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
| Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
| Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
| Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
| Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
| Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
| Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
| Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
| Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
| Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
| Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
| Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |