Depression, AnxietyTODAY!NCT03534167
TODAY! A Mobile App Study
A study testing TODAY! App and Coaching in people with Depression, Anxiety, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 24 years, men only
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- TODAY! App and Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 21.
- Reports currently being in psychotherapy.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614
About this study
Official title: Mobile Phone and Internet-Based Intervention for Vulnerable Youth
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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- TODAY! App and Coaching
- Keywords
- depression, anxiety, gay, youth, Cognitive Behavior Therapy
- Medical subject headings
- Depression, Anxiety Disorders, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TODAY! App and CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TODAY! App and Coaching | Experimental | 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. Receives: Behavioral: TODAY! App and Coaching |
| Referrals | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed at baseline, 5 weeks, 10 weeks and 22 weeks
Secondary outcomes (1)
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.
Measured: Assessed at baseline, 5 weeks, 10 weeks and 22 weeks. Data regarding usage will be generated on the back end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start4 Jun 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diane Chen, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Diane Chen, Ph.D., Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534167
- Sponsor's protocol ID
- 2018-1540
- Acronym
- TODAY!
- Status last verified
- Mar 2023
- First submitted
- 4 May 2018
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Determination made by PI on a case by case basis
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone and Internet-Based Intervention for Vulnerable Youth
- ClinicalTrials.gov ID
- NCT03534167
- Acronym / sponsor ID
- TODAY! / 2018-1540
- Conditions
- Depression, Anxiety
- Keywords
- depression, anxiety, gay, youth, Cognitive Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TODAY! App and Coaching | Experimental | Behavioral: TODAY! App and CoachingRCT 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. |
| Referrals | No intervention | –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. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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 21.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TODAY! App and CoachingThe 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. | Behavioural | TODAY! App and Coaching |
Primary outcome
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.
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.
1 secondary outcome
Usability feedback
Time frame: Assessed at baseline, 5 weeks, 10 weeks and 22 weeks. Data regarding usage will be generated on the back end
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No. Determination made by PI on a case by case basis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Chen, Ph.D. principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TODAY! App and Coaching in people with Depression, Anxiety, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire (PHQ) 9-items (time frame: Assessed at baseline, 5 weeks, 10 weeks and 22 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.