VideoInsight: Video as a Tool to Improve Insight in Schizophrenia

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT02664129
Collaborator
Centre Hospitalier Universitaire de Nīmes (Other)
60
2
2
36.7
30
0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Video self-observation
  • Other: Non Self video observation
N/A

Detailed Description

In everyday practice in psychiatry, some interviews are filmed in order to follow the clinical course and for educational purposes. But the videos are not used as a therapeutic tool for patients. This research project focuses on the therapeutic potential of these videos and particularly on the awareness of patients of their disorder (insight). Patients hospitalized for decompensation of their schizophrenic pathology will be filmed during structured interviews. After clinical stabilization patients will be proposed to participate to this trial. A group of patients (G1) will watch the video recorded in the acute phase of their illness. A control group (G2) will have a usual care without video or specific therapy. 48 hours after, the clinical impact et the evolution of insight of patients will be evaluated. Then follow-up visits will also be provided at one and four months with the same clinical evaluation, plus an evaluation of treatment adherence and functional remission. This study also includes qualitative interviews for group 1 after watching the video to explore the experience of patients in this situation of self-confrontation. The autobiographical memory will also be studied in this protocol. Tolerance of this experience will be assessed by a monitoring of emotions, specifically depressive affects and suicidal ideation. Adverse events will be reported and patients will always have the access to a psychiatrist if necessary.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Video Self-observation as a Therapeutic Tool for Improving the Insight of Patients With Schizophrenia Disorders
Actual Study Start Date :
Dec 8, 2015
Actual Primary Completion Date :
Oct 4, 2018
Actual Study Completion Date :
Dec 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group with video

30 patients will watch the video of them in acute decompensation phase

Other: Video self-observation
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:
  • Group 1
  • 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

    Other: Non Self video observation
    Patients will not watch the video of them in acute decompensation phase.
    Other Names:
  • Group 2
  • Outcome Measures

    Primary Outcome Measures

    1. Unawareness of Mental Disorder (SUMD) [48 hours]

      Scale to assess Unawareness of Mental Disorder (SUMD)

    Secondary Outcome Measures

    1. Insight [48 hours]

      Birchwood Insight Scale

    2. Cognitif Insight [48 hours]

      Beck Cognitive Insight Scale

    3. Positive Symptom [48 hours]

      Positive and Negative Symptom Scale

    4. Negative Symptom [48 hours]

      Positive and Negative Symptom Scale

    5. Depression [48 hours]

      Calgary Depression Scale for Schizophrenia

    6. Autobiographical Memory [48 hours]

      Autobiographical Memory Test

    7. Medication Adherence [48 hours]

      Medication Adherence Rating Scale

    8. Functional Remission (FROGS scale) [48 hours]

      Evaluation of quality of daily life

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Montpellier Montpellier France 34295
    2 University Hospital of Nîmes Nîmes France 30029

    Sponsors and Collaborators

    • University Hospital, Montpellier
    • Centre Hospitalier Universitaire de Nīmes

    Investigators

    • Study Director: Aurélie SCHANDRIN, MD, University hospital of Nîmes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT02664129
    Other Study ID Numbers:
    • UF 9545
    First Posted:
    Jan 26, 2016
    Last Update Posted:
    Dec 30, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 30, 2020