NCT06206226

Brief Summary

The goal of this clinical trial is to see if a mobile phone app can deliver depression treatment to African Americans who are depressed. The main question it aims to answer is if this treatment is effective in reducing symptoms of depression. Participants will attend six 90-minute weekly classes via an app on their phone, and will be asked to complete surveys every week. Participants can expect to be in the study for four months.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable depression

Timeline
9mo left

Started Apr 2026

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress5%
Apr 2026Feb 2027

First Submitted

Initial submission to the registry

January 4, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
2.2 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

January 4, 2024

Last Update Submit

March 3, 2026

Conditions

DepressionDepressive DisorderDepressive Symptoms

Keywords

African American

Outcome Measures

Primary Outcomes (4)

  • Change in Personal Health Questionnaire Depression Scale score

    Using the 8 item Personal Health Questionnaire Depression Scale (PHQ-8), participants will rate how much they have been bothered by symptoms on a scale of 0-3 with a possible range of 0 to 24. Higher scores indicate greater degree of depression.

    Baseline to one month post-intervention (approximately 12 weeks)

  • Change in Generalized Anxiety Disorder 7-item (GAD-7) score

    Using the GAD-7 score, participants will rate how much they have been bothered by symptoms on a scale of 0-3 with a possible range of 0 to 24. Higher scores indicate greater degree of anxiety.

    Baseline to one month post-intervention (approximately 12 weeks)

  • Change in Quick Inventory of Depressive Symptomatology (QIDS)

    Using the 16-item QIDS, participants will rate how much they have been bothered by symptoms on a scale of 0-3 with a possible range of 0 to 27. Higher scores indicate greater degree of depression.

    Baseline to one month post-intervention (approximately 12 weeks)

  • Satisfaction with intervention

    Participants will rate their satisfaction with the intervention by answering a 9-item questionnaire with a scale of 1-7 (1= none of the time, 7= all of the time). Higher scores indicate greater satisfaction with the intervention.

    12 weeks

Study Arms (1)

Oh Happy Day Class-Digital Connections (OHDC-DC)

EXPERIMENTAL
Behavioral: OHDC-DC

Interventions

OHDC-DCBEHAVIORAL

90-minute-weekly cognitive behavioral psycho-education classes using a mobile phone app over a 6-week period

Oh Happy Day Class-Digital Connections (OHDC-DC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African-American
  • Age 18 and older
  • Experiencing depression (as evidenced by a score of 5 or higher on the PHQ-9)
  • Own a mobile phone

You may not qualify if:

  • Individuals who are currently receiving psychotherapy
  • Individuals who are presently experiencing suicidal ideation
  • Individuals who started psychotropic medication less than three months prior to the start of the OHDC will be excluded from the study
  • Participants scoring 25 or higher on the PHQ-9 will be screened out

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

DepressionDepressive Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Study Officials

  • Earlise Ward, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shari Barlow

CONTACT

608-265-4348shari.barlow@fammed.wisc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 16, 2024

Study Start

April 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)