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Clinical Trials/NCT05555745
NCT05555745
Completed
N/A

Audio-based Mental Health Intervention Study

Penn State University1 site in 1 country101 target enrollmentFebruary 15, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
Penn State University
Enrollment
101
Locations
1
Primary Endpoint
Change in symptoms of depression
Status
Completed
Last Updated
6 months ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
February 15, 2023
End Date
September 10, 2024
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michelle G. Newman

Professor

Penn State University

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

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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