- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06206226
The Oh Happy Day Class - Digital Connections (OHDC-DC): A Pilot Study (OHDC-DC)
The Oh Happy Day Class - Digital Connections (OHDC-DC): an Exploratory Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Oh Happy Day Class-Digital Connections (OHDC-DC) is designed for African American adults experiencing clinical depression (CD). OHDC originally comprised of 13 treatment modules focused on culturally relevant strategies to increase knowledge of depression and healthy coping behaviors aimed at reducing symptoms of clinical depression and improving health outcomes.
The Oh Happy Day Class-Digital Connections (OHDC-DC) comprise of 5 core elements of the OHDC-DC:
- 90-minute-weekly cognitive behavioral psycho-education classes over a 6-week period.
- Six classes will be offered and facilitated online in the computerized OHDC-DC.
- Participants will be encouraged to stay engaged between classes by digitally connecting on the app with the class content. On the app they will receive reminders and messages from staff and participants to stay digitally connected and engaged.
- Embedded in the classes and content is psychoeducation with an emphasis on educating participants about depression, raising awareness of mental illness with the goal of normalizing it and reducing stigma, and increasing healthy coping behaviors, and.
- The intervention will be delivered by a licensed mental health clinician.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shari Barlow
- Phone Number: 608-265-4348
- Email: shari.barlow@fammed.wisc.edu
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- University of Wisconsin
-
Principal Investigator:
- Earlise Ward, PhD
-
Contact:
- Shari Barlow
- Phone Number: 608-265-4348
- Email: shari.barlow@fammed.wisc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Oh Happy Day Class-Digital Connections (OHDC-DC)
|
90-minute-weekly cognitive behavioral psycho-education classes using a mobile phone app over a 6-week period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Personal Health Questionnaire Depression Scale score
Time Frame: Baseline to one month post-intervention (approximately 12 weeks)
|
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
Time Frame: Baseline to one month post-intervention (approximately 12 weeks)
|
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)
Time Frame: Baseline to one month post-intervention (approximately 12 weeks)
|
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
Time Frame: 12 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Earlise Ward, PhD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-1437
- A532007 (Other Identifier: UW- Madison)
- SMPH/FAMILY MED/RES GRANTS (Other Identifier: UW- Madison)
- Protocol Version 11/16/23 (Other Identifier: UW- Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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