Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614, United States
NCT Number: NCT03534167
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.
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Notify Me14 year–24 year
Male
Interventional
Not applicable
Chicago, Illinois, 60614, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The TODAY! app uses the skill building structure of Cognitive Behavior Therapy (CBT). The intervention will be divided into "modules," each devoted to a particular skill. Skills addressed within the intervention include increasing social support, engaging in goal-driven behaviors and reducing mood-driven (i.e., avoidance) behaviors, seeking out positive activities, replacing cognitive distortions with more adaptive thinking styles, improving problem-solving skills, reducing avoidance patterns, and increasing alternate coping strategies. The intervention will be supplemented with brief human contact in the form of a motivational coach. The Coach will be trained on the Motivational Interviewing principles upon which the coaching protocol is based.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at baseline, 5 weeks, 10 weeks and 22 weeks. Data regarding usage will be generated on the back end
Usability feedback data will be qualitative, and it may be used to refine intervention components rather than formal analysis. Data entered by the participant into the mobile phone application may also be analyzed for utilization patterns and internal improvements.
Ann & Robert H Lurie Children's Hospital of Chicago
Other
Mobile Phone and Internet-Based Intervention for Vulnerable Youth
Acronym: TODAY!
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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