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Not Yet Recruiting NCT07854301

Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Depression (Trial 2 of 3)

Conditions: Remote vs. In-Person, Remote Visits, In-person Visits

Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 100
Sponsor: State University of New York at Buffalo

Location: University at Buffalo Buffalo New York

Summary

The study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. During the Intake, detailed consent and eligibility assessment will be completed. Participants who are eligible at the Intake will be randomized (within site and Intake Group) to R or IP Treatment and Assessment Groups. Participants will be followed for 3 months.

Eligibility Criteria

INCLUSION CRITERIA: Common to all 3 RCTs: 1. age18+ years 2. stable mailing address (for mailing study packets if assigned to Remote Intake and/or Remote Treatment/Assessment) within accessible range (1.5 hours) of each study site (per self report) 3. able to read, speak \& verbally comprehend English 4. currently own an iOS- or Android-compatible smartphone 5. have a valid e-mail address that is checked regularly (at least once per day) or have regular access to text messages (to access follow-up assessments) Specific to RCT 2: e) Elevated depressive symptoms, defined as a score of \> 10 on the Patient Health Questionnaire-9 (PHQ-9) f) Report willingness to utilize a mobile app for the treatment for depressed mood (response of "yes" on yes/no item) EXCLUSION CRITERIA: Common to All 3 RCTs: 1. consumption of \>28 alcohol-containing drinks per week 2. suicide attempt with at least some wish to die in past 3 months 3. mental illness (such as schizophrenia, bipolar disorder, or major depression) that led to hospitalization in the past 30 days 4. unable/unwilling to provide informed consent or follow directions, inappropriately responsive, based on staff observations Specific to RCT2: 5. Current suicidal ideation at study screening, defined as a response of ≥ 1 on item nine ("Thoughts that you would be better off dead, or of hurting yourself") of the PHQ-9

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07854301). StuddyBuddy aggregates publicly available trial information.