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Audio-based Mental Health Intervention Study

Audio-based Mental Health Intervention Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05555745
Enrollment
101
Registered
2022-09-27
Start date
2023-02-15
Completion date
2024-09-10
Last updated
2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Symptoms

Keywords

digital interventions, mhealth, depression, behavioral activation, podcasts, self-help

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)

Interventions

DEVICEAudio-based behavioral activation intervention

Access to audio-based behavioral activation intervention

DEVICEAudio-based self-monitoring intervention

Access to audio-based self-monitoring intervention

Sponsors

Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in symptoms of depressionMeasured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.Change in symptoms of depression as measured by Beck Depression Inventory-FastScreen (7 items, possible range = 0-21)

Secondary

MeasureTime frameDescription
Change in symptoms of depression, anxiety, and stressMeasured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.Change in symptoms of depression, anxiety, and stress as measured by Depression Anxiety Stress Scales-Short Form (21 items, range = 0-42 per depression, anxiety, or stress sub-scale)
Change in positive affectMeasured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.Change in positive affect, as measured by the Positive and Negative Affect Schedule, positive affect sub-scale (10 items, range = 10-50)
Change in symptoms of depressionMeasured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.Change in symptoms of depression as measured by Patient Health Questionnaire-9 (9 items, range = 0-27)
Change in behavioral activationMeasured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.Change in behavioral activation, as measured by the Behavioral Activation for Depression Scale - Short Form (9 items, range = 0-54)
Change in negative affectMeasured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.Change in negative affect, as measured by the Positive and Negative Affect Schedule, negative affect sub-scale (10 items, range = 10-50)

Other

MeasureTime frameDescription
Intervention satisfactionMeasured at post-intervention (2-weeks)Satisfaction with the intervention, as measured with the mHealth Satisfaction Questionnaire (14 items, range = 14-70)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026