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Video as a Tool to Improve Insight in Schizophrenia (VideoInsight)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Video self-observation
Non Self video observation
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, awareness, insight, video, self-observation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Montpellier
  • University Hospital of Nîmes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental group with video

Control group without video

Arm Description

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

30 patients will not watch the video of them in acute decompensation phase, they pass a standard interview with psychometric scales

Outcomes

Primary Outcome Measures

Unawareness of Mental Disorder (SUMD)
Scale to assess Unawareness of Mental Disorder (SUMD)

Secondary Outcome Measures

Insight
Birchwood Insight Scale
Cognitif Insight
Beck Cognitive Insight Scale
Positive Symptom
Positive and Negative Symptom Scale
Negative Symptom
Positive and Negative Symptom Scale
Depression
Calgary Depression Scale for Schizophrenia
Autobiographical Memory
Autobiographical Memory Test
Medication Adherence
Medication Adherence Rating Scale
Functional Remission (FROGS scale)
Evaluation of quality of daily life

Full Information

First Posted
January 11, 2016
Last Updated
December 29, 2020
Sponsor
University Hospital, Montpellier
Collaborators
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02664129
Brief Title
Video as a Tool to Improve Insight in Schizophrenia
Acronym
VideoInsight
Official Title
Video Self-observation as a Therapeutic Tool for Improving the Insight of Patients With Schizophrenia Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 8, 2015 (Actual)
Primary Completion Date
October 4, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
schizophrenia, awareness, insight, video, self-observation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group with video
Arm Type
Experimental
Arm Description
30 patients will watch the video of them in acute decompensation phase
Arm Title
Control group without video
Arm Type
Sham Comparator
Arm Description
30 patients will not watch the video of them in acute decompensation phase, they pass a standard interview with psychometric scales
Intervention Type
Other
Intervention Name(s)
Video self-observation
Other Intervention Name(s)
Group 1
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Non Self video observation
Other Intervention Name(s)
Group 2
Intervention Description
Patients will not watch the video of them in acute decompensation phase.
Primary Outcome Measure Information:
Title
Unawareness of Mental Disorder (SUMD)
Description
Scale to assess Unawareness of Mental Disorder (SUMD)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Insight
Description
Birchwood Insight Scale
Time Frame
48 hours
Title
Cognitif Insight
Description
Beck Cognitive Insight Scale
Time Frame
48 hours
Title
Positive Symptom
Description
Positive and Negative Symptom Scale
Time Frame
48 hours
Title
Negative Symptom
Description
Positive and Negative Symptom Scale
Time Frame
48 hours
Title
Depression
Description
Calgary Depression Scale for Schizophrenia
Time Frame
48 hours
Title
Autobiographical Memory
Description
Autobiographical Memory Test
Time Frame
48 hours
Title
Medication Adherence
Description
Medication Adherence Rating Scale
Time Frame
48 hours
Title
Functional Remission (FROGS scale)
Description
Evaluation of quality of daily life
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie SCHANDRIN, MD
Organizational Affiliation
University hospital of Nîmes
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
University Hospital of Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34991040
Citation
Schandrin A, Picot MC, Marin G, Andre M, Gardes J, Leger A, O'Donoghue B, Raffard S, Abbar M, Capdevielle D. Video self-confrontation as a therapeutic tool in schizophrenia: A randomized parallel-arm single-blind trial. Schizophr Res. 2022 Feb;240:103-112. doi: 10.1016/j.schres.2021.12.016. Epub 2022 Jan 3.
Results Reference
derived

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Video as a Tool to Improve Insight in Schizophrenia

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