Audio-based Mental Health Intervention Study

NCT05555745 | Completed

• 1 other identifier: STUDY00020667
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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)

Conditions

Depressive Symptoms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in symptoms of depression

  Change in symptoms of depression as measured by Beck Depression Inventory-FastScreen (7 items, possible range = 0-21)

  Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.

Secondary Outcomes (5)

• Change in symptoms of depression

  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

  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

  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

  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

  Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.

Other Outcomes (1)

• Intervention satisfaction

  Measured at post-intervention (2-weeks)

Study Arms (2)

Audio-based behavioral activation intervention

EXPERIMENTAL

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

Audio-based self-monitoring intervention

ACTIVE COMPARATOR

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

Interventions

Audio-based behavioral activation intervention DEVICE

Access to audio-based behavioral activation intervention

Audio-based behavioral activation intervention

Audio-based self-monitoring intervention DEVICE

Access to audio-based self-monitoring intervention

Audio-based self-monitoring intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: February 15, 2023
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)