NCT03585842

Brief Summary

In France, there are no tools for screening psychiatric comorbidities for individuals with Substance Use Disorders. The literature shows that the cooccurrence of these psychiatric disorders in the same individual is frequent. It negatively impacts the healing prognosis, complicates the diagnostic processes and the type of care to be introduced for patients. The creation of reliable, fast and easy-to-use tools for caregivers and researchers is therefore necessary to improve quantitatively and qualitatively the care of patients. There is a Spanish scale that meets these criteria, the Dual Diagnostic Screening Interview (S\_DDSI). The main objective of this study is to validate the DDSI in French. The secondary objectives are the evaluation of the psychometric qualities of F\_DDSI (French version) and adaptation of this scale into an application for Android and iOS.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

2 active sites

Status
unknown

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

March 14, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 13, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

June 28, 2018

Last Update Submit

July 12, 2018

Conditions

Keywords

Scale TranslationSubstance Use DisorderComorbidities psychiatric

Outcome Measures

Primary Outcomes (2)

  • The response rates for each of the item composing the instrument

    From March 14, 2017 to June 2019

  • Psychometric qualities of the new scale

    Sensitivity, specificity, and the positive and negative predictive values for each disorder measured by the DDSI will be calculated in comparison with the MINI

    From March 14, 2017 to June 2019

Study Arms (2)

Pre-test group

Patients from CMP B coming for consultation or day hospital

Other: No intervention

Test group

Patients suffering from DSMV substance use disorder with one or more psychiatric comorbidities

Other: No intervention

Interventions

No intervention

Pre-test groupTest group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Both female and male participants of 18 years old and more are being studied.

You may qualify if:

  • Phase 2 : Patients coming for consultation in the department or day hospital Phase 3: Subjects presenting for one or more substances a diagnosis of Substance Use Disorders (SUD) according to the DSMV criteria.

You may not qualify if:

  • Phase 2
  • Subject who do not understand French
  • Subject unable to answer questions cognitively
  • Phase 3
  • Subject who do not understand French
  • Subject unable to answer questions cognitively
  • Subjects with a mental disorder of the axis I of the DSMIV not stabilized making impossible the filling of the questionnaire (in particular acute states delusional and dissociative)
  • Subjects who participated in the pre-test phase (2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

RECRUITING

CH Etienne Clémentel

Enval, Auvergne, 63530, France

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Georges BROUSSE, PhD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 13, 2018

Study Start

March 14, 2018

Primary Completion

January 31, 2019

Study Completion

June 30, 2019

Last Updated

July 13, 2018

Record last verified: 2018-06

Locations