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Audio-based Mental Health Intervention Study

Primary Purpose

Depressive Symptoms

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Audio-based behavioral activation intervention

Audio-based self-monitoring intervention

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring digital interventions, mhealth, depression, behavioral activation, podcasts, self-help

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

The Pennsylvania State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Audio-based behavioral activation intervention

Audio-based self-monitoring intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in symptoms of depression

Change in symptoms of depression as measured by Beck Depression Inventory-FastScreen (7 items, possible range = 0-21)

Secondary Outcome Measures

Change in symptoms of depression

Change in symptoms of depression as measured by Patient Health Questionnaire-9 (9 items, range = 0-27)

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)

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)

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)

Change in behavioral activation

Change in behavioral activation, as measured by the Behavioral Activation for Depression Scale - Short Form (9 items, range = 0-54)

Full Information

NCT ID

NCT05555745

First Posted

September 22, 2022

Last Updated

March 27, 2023

Sponsor

Penn State University

1. Study Identification

Unique Protocol Identification Number

NCT05555745

Brief Title

Audio-based Mental Health Intervention Study

Official Title

Audio-based Mental Health Intervention Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 15, 2023 (Actual)

Primary Completion Date

May 2025 (Anticipated)

Study Completion Date

May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Symptoms

Keywords

digital interventions, mhealth, depression, behavioral activation, podcasts, self-help

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Audio-based behavioral activation intervention

Arm Type

Experimental

Arm Description

Arm Title

Audio-based self-monitoring intervention

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Audio-based behavioral activation intervention

Intervention Description

Access to audio-based behavioral activation intervention

Intervention Type

Device

Intervention Name(s)

Audio-based self-monitoring intervention

Intervention Description

Access to audio-based self-monitoring intervention

Primary Outcome Measure Information:

Title

Change in symptoms of depression

Description

Change in symptoms of depression as measured by Beck Depression Inventory-FastScreen (7 items, possible range = 0-21)

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in symptoms of depression

Description

Change in symptoms of depression as measured by Patient Health Questionnaire-9 (9 items, range = 0-27)

Time Frame

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

Title

Change in symptoms of depression, anxiety, and stress

Description

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)

Time Frame

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

Title

Change in positive affect

Description

Change in positive affect, as measured by the Positive and Negative Affect Schedule, positive affect sub-scale (10 items, range = 10-50)

Time Frame

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

Title

Change in negative affect

Description

Change in negative affect, as measured by the Positive and Negative Affect Schedule, negative affect sub-scale (10 items, range = 10-50)

Time Frame

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

Title

Change in behavioral activation

Description

Change in behavioral activation, as measured by the Behavioral Activation for Depression Scale - Short Form (9 items, range = 0-54)

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Intervention satisfaction

Description

Satisfaction with the intervention, as measured with the mHealth Satisfaction Questionnaire (14 items, range = 14-70)

Time Frame

Measured at post-intervention (2-weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gavin Rackoff, M.S.

Phone

814-863-0115

gnr18@psu.edu

Facility Information:

Facility Name

The Pennsylvania State University

City

University Park

State/Province

Pennsylvania

ZIP/Postal Code

16802

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gavin N Rackoff, M.S.

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data will be made available upon reasonable request.

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Audio-based Mental Health Intervention Study

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