Schizophrenia Clinical Trial
— RISEOfficial title:
RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia): a Cluster-randomised Trial
Verified date | May 2017 |
Source | London School of Hygiene and Tropical Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether community-based rehabilitation plus facility-based care is superior to facility-based care alone in reducing disability related to schizophrenia in rural Ethiopia.
Status | Completed |
Enrollment | 166 |
Est. completion date | May 8, 2017 |
Est. primary completion date | March 26, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age =18 years - Diagnosis of schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using (DSM-IV) criteria - Evidence of severe, enduring or disabling illness - Resident in kebele for >6 months and no immediate plans to leave the kebele - Has a primary caregiver who is willing to participate in the study Exclusion Criteria: - No specific criteria |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Department of Psychiatry, College of Health Sciences, Addis Ababa University | Addis Ababa |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | Addis Ababa University |
Ethiopia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Discrimination (DISC-12) | Potential mediator | 6 and 12 months | |
Other | Health service use and costs | Potential mediator | 6 and 12 months | |
Other | Depression (PHQ-9+1) | Potential confounder | 6 and 12 months | |
Other | Access/ adherence to CBR and reasons for non-adherence | Potential mediator | 6 and 12 months | |
Other | Social support (OSLO-3) | Potential mediator | 6 and 12 months | |
Other | Stigma and discrimination (WHO Family Interview Schedule Stigma section) | 6 and 12 months | ||
Primary | Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0) | 12 months | ||
Secondary | Symptom severity (Brief Psychiatric Rating Scale- Expanded version (BPRS-E)) | 6 and 12 months | ||
Secondary | Clinical Global Impression (CGI) | 6 and 12 months | ||
Secondary | Relapse (Longitudinal Interval Follow up Evaluation: DSM-IV version (LIFE)) | 6 and 12 months | ||
Secondary | Disability (36-item WHODAS 2.0) | 6 months | ||
Secondary | Functioning (indigenous functioning scale) | Scale is currently under development. It is being designed and validated to measure functioning in people with severe mental illness in rural Ethiopia. | 6 and 12 months | |
Secondary | Economic activity of patient (employment, income and household work) | Section includes current occupation (categories), employment status (categories), typical income (specific amount). Section also includes questions adapted from the WHO-DAS 12 and 36 relating to problems doing usual work task both generally and as a result of their mental illness (likert scale) | 6 and 12 months | |
Secondary | Medication adherence (4 item Morisky Medication Adherence Scale) | 6 and 12 months | ||
Secondary | Engagement with facility based care | Potential mediator | 6 and 12 months | |
Secondary | Proportion with human rights problems (chaining or restraint)- self-reported | The outcome is the proportion chained, restrained or confined within last one month. Additional data on who perpetrated the chaining i.e. traditional healer/ family member will be collected. | 6 and 12 months | |
Secondary | Nutritional status (BMI) | 6 and 12 months | ||
Secondary | Serious adverse events | 6 and 12 months | ||
Secondary | Economic activity of caregiver | Section includes current occupation (categories), employment status (categories), typical income (specific amount). Section also includes questions adapted from the WHO-DAS 12 and 36 relating to problems doing usual work tasks (likert scale). | 6 and 12 months | |
Secondary | Caregiver burden (WHO Family Interview Schedule Impact section) | 6 and 12 months | ||
Secondary | Caregiver depression (PHQ9 +1) | 6 and 12 months | ||
Secondary | Patient medication adherence | 6 and 12 months | ||
Secondary | Proportion with human rights problems (chaining or restraint)- Caregiver-reported | Caregiver to report presence of human rights problems relating to patient. The outcome is the proportion chained, restrained or confined within last one month. Additional data on who perpetrated the chaining i.e. traditional healer/ family member will be collected. | 6 and 12 months |
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 |