Schizophrenia Clinical Trial
— VideoInsightOfficial title:
Video Self-observation as a Therapeutic Tool for Improving the Insight of Patients With Schizophrenia Disorders
Verified date | December 2020 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The deficit of awareness of pathology (or insight) is a common symptom in patients with schizophrenia and has a negative impact on the prognosis of the disease. Current treatments aren't effective enough on this symptom (Pijnenbord et al., 2013). Previous studies have shown a positive impact of videos of patients themselves on insight but they lacked power. This technique needs more investigation. The study aims to improve the patient's awareness of pathology with a video of themselves recorded in the acute phase of their illness. Patients will watch this video after clinical stabilization. This is a randomized controlled and single blinded trial. A population of 60 patients (30 in each group) will be included. The impact on the insight, symptomatology, treatment adherence and functional remission will be evaluated. The video of patient is useful for a personalized clinical follow-up. Its use for therapeutic purposes would be innovative and could be extended to other applications in psychiatry, especially as this tool is readily available.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 30, 2018 |
Est. primary completion date | October 4, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients with a diagnosis of schizophrenia or schizoaffective disorder according to the DSM 5 - Age between 18 and 65 years - Patients initially hospitalized for acute decompensation of their schizophrenia or schizoaffective disorder according to the medical records and any medical certificates - Patients who agreed to be filmed during a standardized interview at screening (in acute decompensation phase of the disease at the beginning of hospitalization) - Clinical state compatible with the therapeutic experience and obtaining consent with a score on the scale of PANSS positive symptoms of less than 24 Exclusion Criteria: - Mental impairment moderate to severe - Central nervous system disease or severe head trauma - Chronic alcohol dependence - Patients hospitalized for a social problem or otherwise, without acute decompensation of their schizophrenia or schizoaffective disorder as assessed by the referring psychiatrist - Patients deprived of liberty by judicial decision - Pregnant and breastfeeding women |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Montpellier | Montpellier | |
France | University Hospital of Nîmes | Nîmes |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Unawareness of Mental Disorder (SUMD) | Scale to assess Unawareness of Mental Disorder (SUMD) | 48 hours | |
Secondary | Insight | Birchwood Insight Scale | 48 hours | |
Secondary | Cognitif Insight | Beck Cognitive Insight Scale | 48 hours | |
Secondary | Positive Symptom | Positive and Negative Symptom Scale | 48 hours | |
Secondary | Negative Symptom | Positive and Negative Symptom Scale | 48 hours | |
Secondary | Depression | Calgary Depression Scale for Schizophrenia | 48 hours | |
Secondary | Autobiographical Memory | Autobiographical Memory Test | 48 hours | |
Secondary | Medication Adherence | Medication Adherence Rating Scale | 48 hours | |
Secondary | Functional Remission (FROGS scale) | Evaluation of quality of daily life | 48 hours |
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