NCT03534167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

June 4, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

4.1 years

First QC Date

May 4, 2018

Last Update Submit

March 2, 2023

Conditions

Depression, Anxiety

Keywords

depressionanxietygayyouthCognitive Behavior Therapy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Assessed at baseline, 5 weeks, 10 weeks and 22 weeks

Secondary Outcomes (1)

  • Usability feedback

    Assessed at baseline, 5 weeks, 10 weeks and 22 weeks. Data regarding usage will be generated on the back end

Study Arms (2)

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.

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.

Interventions

TODAY! App and CoachingBEHAVIORAL

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.

TODAY! App and Coaching

Eligibility Criteria

Age14 Years - 24 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCisgender men (Assigned male at birth and identify as a man)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chicago, Illinois, 60614, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersHomosexuality

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSexualitySexual Behavior

Study Officials

  • Diane Chen, Ph.D.

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Psychologist, Division of Adolescent Medicine

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 23, 2018

Study Start

June 4, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Determination made by PI on a case by case basis

Locations

US(1)