Clinical trial NCT02664129: Video as a Tool to Improve Insight in Schizophrenia
Official title: Video Self-observation as a Therapeutic Tool for Improving the Insight of Patients With Schizophrenia Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: schizophrenia
awareness
insight
video
self-observation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nīmes
First posted: 2016-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Unawareness of Mental Disorder (SUMD)
timeFrame: 48 hours
Secondary outcomes:
measure: Insight
timeFrame: 48 hours
measure: Cognitif Insight
timeFrame: 48 hours
measure: Positive Symptom
timeFrame: 48 hours
measure: Negative Symptom
timeFrame: 48 hours
measure: Depression
timeFrame: 48 hours
measure: Autobiographical Memory
timeFrame: 48 hours
measure: Medication Adherence
timeFrame: 48 hours
measure: Functional Remission (FROGS scale)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
city: Nîmes
country: France
facility: University Hospital of Nîmes
Study officials:
affiliation: University hospital of Nîmes
name: Aurélie SCHANDRIN, MD
role: STUDY_DIRECTOR
References:
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.