NCT02664129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

September 30, 2025

Status Verified

December 1, 2020

Enrollment Period

2.8 years

First QC Date

January 11, 2016

Last Update Submit

September 29, 2025

Conditions

Keywords

schizophreniaawarenessinsightvideoself-observation

Outcome Measures

Primary Outcomes (1)

  • Unawareness of Mental Disorder (SUMD)

    Scale to assess Unawareness of Mental Disorder (SUMD)

    48 hours

Secondary Outcomes (8)

  • Insight

    48 hours

  • Cognitif Insight

    48 hours

  • Positive Symptom

    48 hours

  • Negative Symptom

    48 hours

  • Depression

    48 hours

  • +3 more secondary outcomes

Study Arms (2)

Experimental group with video

EXPERIMENTAL

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

Other: Video self-observation

Control group without video

SHAM COMPARATOR

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

Interventions

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

Also known as: Group 1
Experimental group with video

Patients will not watch the video of them in acute decompensation phase.

Also known as: Group 2
Control group without video

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Montpellier

Montpellier, 34295, France

Location

University Hospital of Nîmes

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Aurélie SCHANDRIN, MD

    University hospital of Nîmes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 26, 2016

Study Start

December 8, 2015

Primary Completion

October 4, 2018

Study Completion

December 30, 2018

Last Updated

September 30, 2025

Record last verified: 2020-12

Locations