Psychiatric DisordersPsyaddictNCT07023419
Psychiatric Disorders in Addiction - Interest of Screening and Influence on Relapse
An observational study of Psychiatric Disorders, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Psychiatric Disorders
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 16 Dec 2024to 16 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'Addictologie - CHU de Strasbourg - France
Strasbourg, 67091
Amaury DURPOIX, MD, 33.6.77.90.62.28, amaury.durpoix@chru-strasbourg.fr
Amaury DURPOIX, MD
About this study
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.
- Conditions
- Psychiatric Disorders
- Keywords
- Psychiatric Disorders, Addiction, Complex detox
- Medical subject headings
- Mental Disorders, Behavior, Addictive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: At 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start16 Dec 2024
- Primary completion16 Oct 2026 (estimated)
- Study completion16 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023419
- Sponsor's protocol ID
- 9533
- Acronym
- Psyaddict
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Disorders in Addiction - Interest of Screening and Influence on Relapse
- ClinicalTrials.gov ID
- NCT07023419
- Acronym / sponsor ID
- Psyaddict / 9533
- Conditions
- Psychiatric Disorders
- Keywords
- Psychiatric Disorders, Addiction, Complex detox
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 16 Oct 2026 (estimated)
- Study completion
- 16 Oct 2026 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Insomnia Severity Score (ISI)
Time frame: At 22 months
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
Depression Scale Score (PHQ 9)
Time frame: At 22 months
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.
Anxiety score (GAD-7)
Time frame: At 22 months
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
Posttraumatic Stress Disorder Score (PCL-5)
Time frame: At 22 months
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.
Addictions Score (DAST-10)
Time frame: At 22 months
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.
ADHD Score
Time frame: At 22 months
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
Autism Score (RAADS-14)
Time frame: At 22 months
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.
Emotion Dysregulation Score (DERS-16)
Time frame: At 22 months
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorders, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amaury DURPOIX, MD (33 6 77 90 62 28, amaury.durpoix@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Score (ISI) (time frame: At 22 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.