TODAY! A Mobile App Study (TODAY!)

• ClinicalTrials.gov Identifier: NCT03534167
• Recruitment Status: Active, not recruiting
• First Posted: May 23, 2018
• Last Update Posted: March 8, 2022
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Information provided by (Responsible Party): Diane Chen, Ann & Robert H Lurie Children's Hospital of Chicago

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Depression, Anxiety	Behavioral: TODAY! App and Coaching	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mobile Phone and Internet-Based Intervention for Vulnerable Youth
• Actual Study Start Date: June 4, 2018
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: June 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: TODAY! App and Coaching; 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; 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.
No Intervention: Referrals; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Patient Health Questionnaire (PHQ) 9-items [ 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.
2. Change in Generalized Anxiety Disorder (GAD) 7-item Questionnaire [ 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.

Secondary Outcome Measures :

1. Usability feedback [ 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.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 24 Years (Child, Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Cisgender men (Assigned male at birth and identify as a man)
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Were assigned male at birth and identify as a man
2. Report romantic/sexual attraction to men;
3. Ages 14-24 years;
4. Resides in the Chicago metro area (i.e., Chicago or suburbs of Cook County)
5. Presents with clinically significant depressive or anxiety symptoms, per a 10+ on the PHQ-9 or 5+ on the GAD-7
6. 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
7. Fluent in English.

Exclusion Criteria:

1. Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of the Internet or mobile phone.
2. 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.
3. 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.
4. Is concurrently participating in another behavioral intervention research study
5. Reports currently being in DCFS custody and under 21.
6. Reports currently being in psychotherapy.
7. 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.
8. Less than an 8th grade reading level.
9. Does not have an email address and does not obtain one within 1 week of the telephone screening.

Contacts and Locations

Locations

United States, Illinois

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60614

Sponsors and Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

• Principal Investigator: Diane Chen, Ph.D.; Ann & Robert H Lurie Children's Hospital of Chicago

More Information

• Responsible Party: Diane Chen, Medical Psychologist, Division of Adolescent Medicine, Ann & Robert H Lurie Children's Hospital of Chicago
• ClinicalTrials.gov Identifier: NCT03534167
• Other Study ID Numbers: 2018-1540
• First Posted: May 23, 2018
• Last Update Posted: March 8, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Determination made by PI on a case by case basis

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Diane Chen, Ann & Robert H Lurie Children's Hospital of Chicago:

depression; anxiety; gay; youth; Cognitive Behavior Therapy

Additional relevant MeSH terms:

Depression; Behavioral Symptoms