An interventional study of TODAY! App and Coaching in Depression, Anxiety, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Completed at 1 site in United States. Open to male participants aged 14 Years to 24 Years. Per ClinicalTrials.gov, last updated 2023-03-03.
Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 22 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 176 studies on the registry; 30 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
RCT participants will be randomized into a 10-week intervention condition during which they will receive the CBT modules through the TODAY! app. In addition to the mobile app, participants will receive coaching from the study Coach who is trained in Motivational Interviewing principles. Participants will complete mood and behavior assessments at 4 time-points over the course of 22 weeks.
Behavioral: TODAY! App and Coaching
RCT participants will be randomized into a 10-week wait-list control condition and will be provided with and encouraged to use mental health and lesbian, gay, bisexual, queer (LGBQ) referrals and resources in the community. Participants will complete mood and behavior assessments at 4 time-points over the course of 22 weeks. After the 22-week post intervention follow-up, control group participants will have the option to receive the intervention, however they will not be administered follow-up assessments or given coaching.
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.
Change in Patient Health Questionnaire (PHQ) 9-items
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
Change in Generalized Anxiety Disorder (GAD) 7-item Questionnaire
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
Usability feedback
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.
Time frame: Assessed at baseline, 5 weeks, 10 weeks and 22 weeks. Data regarding usage will be generated on the back end
Plan to share: No — Determination made by PI on a case by case basis
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Ann & Robert H Lurie Children's Hospital of Chicago