Audio-based Mental Health Intervention Study

Depressive Symptoms Clinical Trial

Official title:

Audio-based Mental Health Intervention Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555745
• Other study ID #: STUDY00020667
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: May 2025

Study information

• Verified date: March 2023
• Source: Penn State University
• Contact: Gavin Rackoff, M.S.
• Phone: 814-863-0115
• Email: gnr18[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Device:
• Audio-based behavioral activation intervention
Access to audio-based behavioral activation intervention
• Audio-based self-monitoring intervention
Access to audio-based self-monitoring intervention

Locations

Country	Name	City	State
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention satisfaction	Satisfaction with the intervention, as measured with the mHealth Satisfaction Questionnaire (14 items, range = 14-70)	Measured at post-intervention (2-weeks)
Primary	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	Change in symptoms of depression	Change in symptoms of depression as measured by Patient Health Questionnaire-9 (9 items, range = 0-27)	Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
Secondary	Change in symptoms of depression, anxiety, and stress	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)	Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
Secondary	Change in positive affect	Change in positive affect, as measured by the Positive and Negative Affect Schedule, positive affect sub-scale (10 items, range = 10-50)	Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
Secondary	Change in negative affect	Change in negative affect, as measured by the Positive and Negative Affect Schedule, negative affect sub-scale (10 items, range = 10-50)	Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.
Secondary	Change in behavioral activation	Change in behavioral activation, as measured by the Behavioral Activation for Depression Scale - Short Form (9 items, range = 0-54)	Measured at baseline, 1-week, 2-week, 5-week. Outcome is change from baseline to each of the subsequent time points.