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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05555745
Other study ID # STUDY00020667
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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