NCT07023419

Brief Summary

In complex detoxification hospital units, patients receive a common care system (interviews, therapeutic workshops, support for discharges, etc.). In the event of a relapse during hospitalization, i.e., a relapse into addiction, hospital care is called into question, and discharge is generally considered. A key care issue is therefore to prevent these relapses by identifying risk profiles to strengthen their management. According to studies, psychiatric diagnoses increase the risk of relapse, but the investigators do not fully understand which ones or to what extent. The objective of this study is to analyze the influence of psychiatric diagnoses on the risk of relapse. This would allow for adapting the care of these patients to reduce this risk. The investigators are also seeking to study the value of screening questionnaires in improving the reliability of psychiatric diagnoses.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress76%
Dec 2024Oct 2026

Study Start

First participant enrolled

December 16, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2026

Last Updated

June 22, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

March 24, 2025

Last Update Submit

June 17, 2025

Conditions

Keywords

Psychiatric DisordersAddictionComplex detox

Outcome Measures

Primary Outcomes (8)

  • Insomnia Severity Score (ISI)

    The ISI is a scale composed of 7 questions: Each of the 7 items is rated on a 5-point Likert scale (from 0 to 4). The total score is obtained by adding the scores for all 7 items (1a+1b+1c+2+3+4+5). The total score ranges from 0 to 28: 0-7 = No insomnia 8-14 = Subclinical (mild) insomnia 15-21 = Clinical (moderate) insomnia 22-28 = Clinical (severe) insomnia

    At 22 months

  • Depression Scale Score (PHQ 9)

    Depression Scale Score (PHQ 9) * Items are rated on a scale from 0 to 3. The maximum score is 27. * The threshold for assessing moderate depression (10 or higher) is the most commonly used. • Thresholds: No depression: 0-4 points; Mild depression: 5-9 points; Moderate depression: 10-14 points; Moderately severe depression: 15-19 points; Severe depression: 20-27 points.

    At 22 months

  • Anxiety score (GAD-7)

    Anxiety score (GAD-7): The total score of the GAD-7 questionnaire ranges from 0 to 21 points. Scores of 5, 10, and 15 represent thresholds for detecting mild, moderate, or severe anxiety: Score 0-4: Minimal anxiety Score 5-9: Mild anxiety Score 10-14: Moderate anxiety Score above 15: Severe anxiety

    At 22 months

  • Posttraumatic Stress Disorder Score (PCL-5)

    Posttraumatic Stress Disorder Score (PCL-5): The PCL-5 scale assesses the presence and severity of PTSD using 20 items. The PTSD severity score ranges from 0 (not present at all) to 4 (extremely), resulting in a total score between 0 and 80. PCL-5 scores were used to determine the presence of PTSD.: A score: above 33 indicates the presence of PTSD, between 31 and 33 indicates probable PTSD below 31 indicates no PTSD.

    At 22 months

  • Addictions Score (DAST-10)

    Addictions Score (DAST-10): The maximum total score is 10. A threshold of 3 or 4 is recommended for screening for a drug use problem. This threshold would most closely match the criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM): A score of 9 or higher indicates a severe problem.

    At 22 months

  • ADHD Score

    ADHD Score: Points are summed on a scale of 0 to 24, with a threshold of 14 or higher for a positive ADHD screen result. The total score can be categorized into four strata: 0 to 9 = weakly negative 10 to 13 = strongly negative 14 to 17 = weakly positive 18 to 24 = strongly positive

    At 22 months

  • Autism Score (RAADS-14)

    Autism Score (RAADS-14): The RAADS-R test calculates a score indicating the likelihood of an autism spectrum disorder in the individual taking it. The total score on the RAADS-R test ranges from 0 to 240. Higher scores indicate behaviors and symptoms consistent with autism. Scores equal to or greater than 65 indicate the presence of autism.

    At 22 months

  • Emotion Dysregulation Score (DERS-16)

    Emotion Dysregulation Score (DERS-16) A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) cognitive reappraisal and (2) expressive suppression. Respondents respond to each item on a 7-point Likert-type scale, ranging from 1 (strongly disagree) to 7 (strongly agree).

    At 22 months

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subject aged ≥16 and having been hospitalized in the complex withdrawal unit of the Strasbourg psychiatric clinic during the period from January 1, 2024 to November 1, 2024

You may qualify if:

  • Subject aged ≥16
  • Having been hospitalized in the complex withdrawal unit of the Strasbourg psychiatric clinic during the period from January 1, 2024 to November 1, 2024

You may not qualify if:

  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Addictologie - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Mental DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2025

First Posted

June 17, 2025

Study Start

December 16, 2024

Primary Completion (Estimated)

October 16, 2026

Study Completion (Estimated)

October 16, 2026

Last Updated

June 22, 2025

Record last verified: 2025-03

Locations