- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02664129
Video as a Tool to Improve Insight in Schizophrenia (VideoInsight)
Video Self-observation as a Therapeutic Tool for Improving the Insight of Patients With Schizophrenia Disorders
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Montpellier, France, 34295
- University Hospital of Montpellier
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Nîmes, France, 30029
- University Hospital of Nimes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group with video
30 patients will watch the video of them in acute decompensation phase
|
Patients will watch the video of them in acute decompensation phase then they will be asked about their emotions, their understanding and awareness of mental illness
Other Names:
|
|
Sham Comparator: Control group without video
30 patients will not watch the video of them in acute decompensation phase, they pass a standard interview with psychometric scales
|
Patients will not watch the video of them in acute decompensation phase.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Unawareness of Mental Disorder (SUMD)
Time Frame: 48 hours
|
Scale to assess Unawareness of Mental Disorder (SUMD)
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insight
Time Frame: 48 hours
|
Birchwood Insight Scale
|
48 hours
|
|
Cognitif Insight
Time Frame: 48 hours
|
Beck Cognitive Insight Scale
|
48 hours
|
|
Positive Symptom
Time Frame: 48 hours
|
Positive and Negative Symptom Scale
|
48 hours
|
|
Negative Symptom
Time Frame: 48 hours
|
Positive and Negative Symptom Scale
|
48 hours
|
|
Depression
Time Frame: 48 hours
|
Calgary Depression Scale for Schizophrenia
|
48 hours
|
|
Autobiographical Memory
Time Frame: 48 hours
|
Autobiographical Memory Test
|
48 hours
|
|
Medication Adherence
Time Frame: 48 hours
|
Medication Adherence Rating Scale
|
48 hours
|
|
Functional Remission (FROGS scale)
Time Frame: 48 hours
|
Evaluation of quality of daily life
|
48 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Aurélie SCHANDRIN, MD, University Hospital of Nimes
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9545
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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