Audio-based Mental Health Intervention Study

NCT ID: NCT05555745

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2024-09-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 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.

Group Type: EXPERIMENTAL

Audio-based behavioral activation intervention

Intervention Type: DEVICE

Access to audio-based behavioral activation intervention

Audio-based self-monitoring 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.

Group Type: ACTIVE_COMPARATOR

Audio-based self-monitoring intervention

Intervention Type: DEVICE

Access to audio-based self-monitoring intervention

Interventions

Audio-based behavioral activation intervention

Access to audio-based behavioral activation intervention

Intervention Type: DEVICE

Audio-based self-monitoring intervention

Access to audio-based self-monitoring intervention

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Michelle G. Newman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Pennsylvania State University

University Park, Pennsylvania, United States

Countries

United States

Study Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

STUDY00020667

Identifier Type: -

Identifier Source: org_study_id