Clinical trial NCT06206226: The Oh Happy Day Class - Digital Connections (OHDC-DC): A Pilot Study
Official title: The Oh Happy Day Class - Digital Connections (OHDC-DC): an Exploratory Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Depressive Disorder
Depressive Symptoms
Keywords: African American
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Personal Health Questionnaire Depression Scale score
timeFrame: Baseline to one month post-intervention (approximately 12 weeks)
measure: Change in Generalized Anxiety Disorder 7-item (GAD-7) score
timeFrame: Baseline to one month post-intervention (approximately 12 weeks)
measure: Change in Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: Baseline to one month post-intervention (approximately 12 weeks)
measure: Satisfaction with intervention
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Earlise Ward, PhD
role: PRINCIPAL_INVESTIGATOR
References: