Mobile Phone and Internet-Based Intervention for Vulnerable Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in Patient Health Questionnaire (PHQ) 9-items
研究概览
简要总结
The aim of this study is to conduct a small randomized controlled trial (RCT) for a 10-week mobile phone intervention using principles of Cognitive Behavior Therapy to target general and minority stressors and treat anxiety and depression in young men romantically/sexually attracted to men.
详细描述
Investigators will conduct a double-arm RCT to develop the infrastructure and collection of data needed to power a larger RCT (e.g., rates of consent, retention rates). Clinical outcomes will be assessed for the purpose of detecting unexpected deterioration. Investigators will also collect usability feedback regarding the intervention which may be used to refine the treatment. Usage data will be used to identify under-used lessons and tools and improve their usefulness/appeal. Compliance with assessments will be monitored and used to improve retention protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Were assigned male at birth and identify as a man
- •Report romantic/sexual attraction to men;
- •Ages 14-24 years;
- •Resides in the Chicago metro area (i.e., Chicago or suburbs of Cook County)
- •Presents with clinically significant depressive or anxiety symptoms, per a 10+ on the PHQ-9 or 5+ on the GAD-7
- •Currently owns a mobile phone that is compatible with the intervention application, and believes they will be able to keep using this mobile phone for the next 10 weeks
- •Fluent in English.
排除标准
- •Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of the Internet or mobile phone.
- •Per self-reported history or the Mini-International Neuropsychiatric Interview (MINI) 7 (Adult version for participants ages 17-24 years and Kid version for ages 14-16 years), has ever been diagnosed with a psychotic disorder or bipolar disorder, or is currently diagnosed with obsessive compulsive disorder, or has been diagnosed in the past two years with posttraumatic stress disorder, dissociative disorder, or eating disorder; or evidences another condition that indicates this intervention may be insufficient to meet the youth's needs. If substance abuse disorder is currently present, PI or designated individual will use clinical judgement to determine whether severity/impairment related to substance use indicates this intervention may be insufficient to meet the youth's needs.
- •Has been hospitalized for psychiatric reasons or has attempted suicide in the last year, or has a score of 4 or more (i.e., "high" to "severe" suicidality) on the Columbia Suicide Severity Rating Scale, or reports non-suicidal self-injury of a nature that suggests this intervention may be insufficient to meet the youth's needs.
- •Is concurrently participating in another behavioral intervention research study
- •Reports currently being in DCFS custody and under
- •Reports currently being in psychotherapy.
- •Initiation, discontinuation, or adjustment of antidepressant medication in the past 4 weeks. Individuals excluded solely for this reason will be allowed to retake the baseline assessments (and be compensated accordingly) to determine eligibility after they have been on a stable antidepressant regimen for 4 weeks, if the study is still enrolling at that time.
- •Less than an 8th grade reading level.
- •Does not have an email address and does not obtain one within 1 week of the telephone screening.
结局指标
主要结局
Change in Patient Health Questionnaire (PHQ) 9-items
时间窗: Assessed at baseline, 5 weeks, 10 weeks and 22 weeks
The PHQ-9 is a brief validated depression module. This study will measure change in PHQ-9 scores.
Change in Generalized Anxiety Disorder (GAD) 7-item Questionnaire
时间窗: Assessed at baseline, 5 weeks, 10 weeks and 22 weeks
The GAD-7 is a brief measure assessing anxiety. This study will measure change in GAD-7 scores.
次要结局
- Usability feedback(Assessed at baseline, 5 weeks, 10 weeks and 22 weeks. Data regarding usage will be generated on the back end)
研究者
Diane Chen
Medical Psychologist, Division of Adolescent Medicine
Ann & Robert H Lurie Children's Hospital of Chicago