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临床试验/NCT07023419
NCT07023419招募中不适用

Psychiatric Disorders in Addiction - Interest of Screening and Influence on Relapse

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Insomnia Severity Score (ISI)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Refusal to participate in the study

结局指标

主要结局

Insomnia Severity Score (ISI)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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.

ADHD Score

时间窗: 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)

时间窗: 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)

时间窗: 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).

Addictions Score (DAST-10)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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