Audio-based Mental Health Intervention Study

Not Applicable

Recruiting

• Conditions: Depressive Symptoms
• Interventions: Device: Audio-based behavioral activation intervention; Device: Audio-based self-monitoring intervention

• Registration Number: NCT05555745
• Lead Sponsor: Penn State University

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Study Start: 2023-02-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Audio-based behavioral activation intervention	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.
Audio-based self-monitoring 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 negative affect, as measured by the Positive and Negative Affect Schedule, negative affect sub-scale (10 items, range = 10-50)
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 as measured by Patient Health Questionnaire-9 (9 items, range = 0-27)
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 positive affect, as measured by the Positive and Negative Affect Schedule, positive affect sub-scale (10 items, range = 10-50)
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 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 behavioral activation	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)

Trial Locations

Locations (1)

The Pennsylvania State University; 🇺🇸 University Park, Pennsylvania, United States