Clinical trial NCT05555745: Audio-based Mental Health Intervention Study
Official title: Audio-based Mental Health Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Keywords: digital interventions
mhealth
depression
behavioral activation
podcasts
self-help
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study on an audio-based digital intervention designed to reduce symptoms of depression. Participants who experience at least moderate symptoms of depression will be invited to participate in the study. Participants will be randomly assigned to receive one of two audio-based digital interventions. The experimental intervention based on behavioral activation treatment for depression. The control intervention is based on self-monitoring. Depression symptoms and related mental health symptoms, as well as experiences with the intervention, will be assessed at baseline (pre-randomization), mid-intervention (1 week post-randomization), post-intervention (2 weeks post-randomization) and follow-up (5 weeks post-randomization)


Eligibility criteria: Inclusion Criteria:

* Adult age 18 or older
* Score in the moderate or higher range on the BDI-FastScreen
* Moderate or higher depression confirmed by DIAMOND interview
* Proficient English reading, writing, and speaking ability
* Able to provide consent
* Provide informed consent

Exclusion Criteria:

* Below 18 years of age
* Score below the moderate range on the BDI-FastScreen
* DIAMOND interview does not confirm moderate or higher depression
* Unable to read, write, and speak in English
* Unable to provide consent
* Do not provide informed consent

Primary outcomes:
measure: Change in symptoms of depression
timeFrame: Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
Secondary outcomes:
measure: Change in symptoms of depression
timeFrame: Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
measure: Change in symptoms of depression, anxiety, and stress
timeFrame: Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
measure: Change in positive affect
timeFrame: Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
measure: Change in negative affect
timeFrame: Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
measure: Change in behavioral activation
timeFrame: Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
Other outcomes:
measure: Intervention satisfaction
timeFrame: Measured at post-intervention (2-weeks)
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
References: