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Completed

NCT Number: NCT05555745

Audio-based Mental Health Intervention Study

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)

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Audio-based behavioral activation intervention

Device

Access to audio-based behavioral activation intervention

Audio-based self-monitoring intervention

Device

Access to audio-based self-monitoring intervention

Primary outcomes

  1. Change in symptoms of depression

    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 as measured by Beck Depression Inventory-FastScreen (7 items, possible range = 0-21)

Secondary outcomes

  1. Change in symptoms of depression

    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 as measured by Patient Health Questionnaire-9 (9 items, range = 0-27)

  2. Change in symptoms of depression, anxiety, and stress

    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 as measured by Depression Anxiety Stress Scales-Short Form (21 items, range = 0-42 per depression, anxiety, or stress sub-scale)

  3. Change in positive affect

    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, as measured by the Positive and Negative Affect Schedule, positive affect sub-scale (10 items, range = 10-50)

  4. Change in negative affect

    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, as measured by the Positive and Negative Affect Schedule, negative affect sub-scale (10 items, range = 10-50)

  5. Change in behavioral activation

    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, as measured by the Behavioral Activation for Depression Scale - Short Form (9 items, range = 0-54)

Other outcomes

  1. Intervention satisfaction

    Time frame: Measured at post-intervention (2-weeks)

    Satisfaction with the intervention, as measured with the mHealth Satisfaction Questionnaire (14 items, range = 14-70)

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2022
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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