Audio-based Mental Health Intervention Study

Study Overview
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Brief Summary
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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)

Official Title
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Audio-based Mental Health Intervention Study

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Device: Audio-based behavioral activation intervention
* Device: Audio-based self-monitoring intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Audio-based behavioral activation intervention<br>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. | Device: Audio-based behavioral activation intervention<br>* Access to audio-based behavioral activation intervention<br>|
| Active Comparator: Audio-based self-monitoring intervention<br>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. | Device: Audio-based self-monitoring intervention<br>* Access to audio-based self-monitoring intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital interventions, mhealth, depression, behavioral activation, podcasts, self-help