An interventional study of Audio-based behavioral activation intervention and Audio-based self-monitoring intervention in Depressive Symptoms, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by Penn State University · Not applicable, Interventional, and Treatment
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)
8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 101 is above the median of 84 across 6,718 interventional studies indexed under Depression.
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Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
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Exclusion Criteria:
This intervention consists of two audio-based sessions delivered one week apart. The first session lasts approximately 30 minutes, and the second session lasts approximately 15 minutes. The sessions are audio recordings. The first session introduces behavioral activation and provides instruction for how to schedule and engage in positively reinforcing activities. The second session recaps the principles of behavioral activation and guides participants through methods of troubleshooting. After each session, participants are asked to create an activity schedule for the coming week. Then, each day in the week following each session, participants receive an email with a survey asking them to report on their activity and mood in the previous day.
Device: Audio-based behavioral activation intervention
This intervention consists of two audio-based sessions delivered one week apart. The first session lasts approximately 30 minutes, and the second session lasts approximately 15 minutes. The sessions are audio recordings. The first session introduces information about emotion and provides instruction for how to track emotion using self-monitoring. The second session provides more information about emotion and recaps instructions for self-monitoring. Each day in the week following each session, participants receive an email with a survey asking them to report on their mood in the previous day.
Device: Audio-based self-monitoring intervention
Access to audio-based behavioral activation intervention
Access to audio-based self-monitoring intervention
Change in symptoms of depression
Change in symptoms of depression as measured by Beck Depression Inventory-FastScreen (7 items, possible range = 0-21)
Time frame: Measured 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
Change in symptoms of depression as measured by Patient Health Questionnaire-9 (9 items, range = 0-27)
Time frame: Measured 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
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)
Time frame: Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
Change in positive affect
Change in positive affect, as measured by the Positive and Negative Affect Schedule, positive affect sub-scale (10 items, range = 10-50)
Time frame: Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
Change in negative affect
Change in negative affect, as measured by the Positive and Negative Affect Schedule, negative affect sub-scale (10 items, range = 10-50)
Time frame: Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
Change in behavioral activation
Change in behavioral activation, as measured by the Behavioral Activation for Depression Scale - Short Form (9 items, range = 0-54)
Time frame: Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
Intervention satisfaction
Satisfaction with the intervention, as measured with the mHealth Satisfaction Questionnaire (14 items, range = 14-70)
Time frame: Measured at post-intervention (2-weeks)
Plan to share: No — Data will be made available upon reasonable request.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Penn State University