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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06206226
Other study ID # 2023-1437
Secondary ID A532007SMPH/FAMI
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2024
Est. completion date August 2025

Study information

Verified date May 2024
Source University of Wisconsin, Madison
Contact Mary Checovich
Phone 608-263-2653
Email mary.checovich@fammed.wisc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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: 1. 90-minute-weekly cognitive behavioral psycho-education classes over a 6-week period. 2. Six classes will be offered and facilitated online in the computerized OHDC-DC. 3. 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. 4. 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. 5. The intervention will be delivered by a licensed mental health clinician.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 8
Est. completion date August 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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
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