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Audio-Based Mental Health Intervention for Depression
N/A
Recruiting
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, 1-week, 2-week, 5-week. outcome is change from baseline to each of the subsequent time points.
Awards & highlights
No Placebo-Only Group
Summary
This trial examines how an audio-based intervention can reduce depression symptoms. Participants will be randomly assigned to either an experimental or control intervention. Results will be monitored at various times throughout the trial.
Who is the study for?
This trial is for adults over 18 who can read, write, and speak English well. They must have moderate or severe depression confirmed by an interview and a specific depression screening test. Participants need to be able to consent to the study.
What is being tested?
The study tests two audio-based digital interventions aimed at reducing depression symptoms. One uses behavioral activation techniques while the other focuses on self-monitoring. Progress is checked several times from start to follow-up after five weeks.
What are the potential side effects?
Since this trial involves non-medical interventions like listening to audio recordings, side effects are minimal but may include discomfort or emotional distress related to discussing personal mental health issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline, 1-week, 2-week, 5-week. outcome is change from baseline to each of the subsequent time points.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, 1-week, 2-week, 5-week. outcome is change from baseline to each of the subsequent time points.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in behavioral activation
Change in negative affect
Change in positive affect
+2 moreOther study objectives
Intervention satisfaction
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Audio-based behavioral activation interventionExperimental Treatment1 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 II: Audio-based self-monitoring interventionActive Control1 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.
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Who is running the clinical trial?
Penn State UniversityLead Sponsor
370 Previous Clinical Trials
127,879 Total Patients Enrolled
14 Trials studying Depression
1,819 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am unable to give my consent.I am under 18 years old.I cannot read, write, or speak in English.
Research Study Groups:
This trial has the following groups:- Group 1: Audio-based behavioral activation intervention
- Group 2: Audio-based self-monitoring intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.