Audio-Based Mental Health Intervention for Depression

Overseen By Gavin N Rackoff, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two audio-based methods to help reduce depression symptoms. The audio-based behavioral activation intervention encourages activities that improve mood, while the audio-based self-monitoring intervention involves tracking emotions. Individuals experiencing at least moderate depression symptoms and who can communicate in English may be suitable candidates. Participants will attend two audio sessions and provide feedback about their mood and activities over several weeks. As an unphased trial, this study offers a unique opportunity to explore innovative treatments for depression symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that digital treatments for improving mood are generally safe and effective. Studies have found that most people handle these treatments well, with no major side effects reported.

For the audio-based self-monitoring part of the study, similar digital mental health tools are also considered safe. Reviews indicate they are usually well-received and rarely cause harm.

Both treatments in this trial involve listening to audio sessions and completing simple tasks. These methods are non-invasive and use everyday technology, making them a low-risk option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for depression, such as antidepressant medications and traditional talk therapy, can take weeks or even months to show results. But the audio-based interventions being explored offer a fresh approach. Researchers are excited because these interventions are delivered through brief audio sessions, making them more accessible and less time-consuming. The first treatment uses behavioral activation, guiding participants to engage in positive activities, while the second focuses on self-monitoring emotions. Both methods are designed to empower individuals to manage their mood and activities independently, potentially offering quicker and more convenient support than standard treatments.

What evidence suggests that this trial's audio-based digital interventions could be effective for depression?

Research has shown that behavioral activation, a key component of the audio-based behavioral activation intervention in this trial, effectively reduces depression symptoms. Studies have found that digital versions of behavioral activation can lessen these symptoms and improve quality of life in the short to mid-term. Previous patients experienced positive results with internet-based behavioral activation, highlighting its effectiveness.

In this trial, another group of participants will receive the audio-based self-monitoring intervention. Evidence for digital self-monitoring is more mixed. While digital mental health tools like self-monitoring have potential, their effectiveness alone is less clear. Self-monitoring helps people track their emotions but may not reduce depression symptoms as effectively as behavioral activation. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to provide consent

Proficient English reading, writing, and speaking ability

Score in the moderate or higher range on the BDI-FastScreen

Exclusion Criteria

Score below the moderate range on the BDI-FastScreen

I am unable to give my consent.

Do not provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of two audio-based digital interventions over two weeks, with sessions delivered one week apart

2 weeks

2 audio sessions

Follow-up

Participants are monitored for changes in symptoms of depression, anxiety, stress, and affect, as well as intervention satisfaction

3 weeks

Assessments at 1-week, 2-week, and 5-week post-randomization

What Are the Treatments Tested in This Trial?

Interventions

• Audio-based behavioral activation intervention
• Audio-based self-monitoring intervention

Trial Overview

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.

How Is the Trial Designed?

Group I: Audio-based behavioral activation intervention Experimental Treatment 1 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 intervention Active Control 1 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.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Published Research Related to This Trial

Internet-based behavioral activation (iBA) significantly reduces depressive symptoms compared to inactive control groups, with a moderate effect size based on a systematic review of 12 randomized controlled trials involving 3274 participants.

iBA also leads to reductions in anxiety and improvements in quality of life and activation, although no significant effects on depressive symptoms were observed at the 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based Behavioral Activation for Depression: Systematic Review and Meta-Analysis. Alber, CS., Krämer, LV., Rosar, SM., et al.[2023]

Behavioral Activation (BA) is a well-supported psychotherapy for depression that has evolved over the years, incorporating various techniques such as activity monitoring, scheduling, and skills training, which have empirical support as effective components.

While some techniques like activity scheduling and relaxation training have been validated as effective on their own, others are more effective when used as part of a comprehensive treatment package, highlighting the importance of a tailored approach in BA interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is behavioral activation? A review of the empirical literature. Kanter, JW., Manos, RC., Bowe, WM., et al.[2022]

Behavioral activation (BA) is an effective treatment for depression, but many patients still experience treatment failure due to various factors, such as difficulty understanding the treatment rationale and behavioral noncompliance.

A case study of a depressed breast cancer patient highlights these challenges and suggests that improving patient awareness of life values and enhancing contingency management could help reduce failure rates in BA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment failure in behavior therapy: focus on behavioral activation for depression. Hopko, DR., Magidson, JF., Lejuez, CW.[2022]

A study involving seven patients with bipolar depression analyzed 2,480 hours of self-reported activities, revealing that movement-related activities were linked to the highest pleasure scores, suggesting that physical activity may enhance mood.

The research demonstrated the feasibility of using a data-driven approach to identify behavioral patterns, which could inform therapists and lead to the development of digital solutions for behavioral activation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. Rohani, DA., Tuxen, N., Quemada Lopategui, A., et al.[2020]

This study will evaluate the effectiveness of an 8-week smartphone-based behavioral activation intervention for major depressive disorders, involving 120 participants split into treatment and control groups.

The intervention aims to integrate technology into mental health care, allowing therapists to monitor patient activities through a smartphone app, potentially enhancing treatment accessibility and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial. Ly, KH., Carlbring, P., Andersson, G.[2022]

The Behavioral Apptivation mobile application was developed to support Brief Behavioral Activation Treatment for Depression (BATD), which is a well-supported psychotherapy for treating depression.

Initial pilot testing of the app in a small open-label trial showed feasibility for use alongside individual BATD therapy, suggesting it could enhance clinical practice for treating depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Preliminary Feasibility Study of a Brief Behavioral Activation Mobile Application (Behavioral Apptivation) to Be Used in Conjunction With Ongoing Therapy. Dahne, J., Kustanowitz, J., Lejuez, CW.[2020]

A systematic review of nine randomized controlled trials involving 2157 adult participants found that guided Internet-based behavioral activation (BA) is effective in reducing depression and anxiety, showing promising results compared to other treatments like physical activity and psychoeducation.

While Internet-based BA demonstrated non-inferior efficacy to other behavioral therapies and mindfulness, the overall quality of evidence was low to moderate, indicating a need for more rigorous studies to confirm its effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. Huguet, A., Miller, A., Kisely, S., et al.[2019]

A web-based behavioral activation intervention called Bounce Back Now (BBN) was developed to help adolescents with depression, showing promising feasibility based on usability evaluations with 24 adolescents and preliminary data from 2,000 disaster-affected youth.

The intervention received positive feedback from users and demonstrated moderate levels of access, suggesting that web-based approaches could effectively improve treatment access for adolescents who might not seek traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility assessment of a brief, web-based behavioral activation intervention for adolescents with depressed mood. Davidson, TM., Yuen, EK., Felton, JW., et al.[2014]

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