Audio-Based Mental Health Intervention for Depression

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Penn State University

Disqualifiers: Under 18, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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)

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.

What data supports the effectiveness of the audio-based mental health treatment for depression?

Research shows that behavioral activation, a key component of the audio-based treatment, is effective in reducing depression symptoms. Internet-based and mobile applications of behavioral activation have been shown to improve access and provide effective support for managing depression. ^{1 2 3 4 5}

Is audio-based mental health intervention for depression safe for humans?

The research on internet-based and web-based behavioral activation interventions, which are similar to audio-based interventions, suggests they are generally safe for humans, as they focus on changing behavior patterns without involving medication or invasive procedures. ^{1 3 5 6 7}

How is the audio-based behavioral activation intervention for depression different from other treatments?

This treatment is unique because it uses audio-based guidance to deliver behavioral activation, making it more accessible and convenient for people who may not have access to traditional therapy sessions. Unlike standard treatments that require in-person interaction, this approach can be delivered digitally, potentially reaching a wider audience and providing support in a more flexible manner. ^{1 2 3 6 8}

Research Team

Eligibility Criteria

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

I am 18 years old or older.

Able to provide consent

Proficient English reading, writing, and speaking ability

Exclusion Criteria

Score below the moderate range on the BDI-FastScreen

I am unable to give my consent.

Do not provide informed consent

Trial Timeline

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

Treatment Details

Interventions

• Audio-based behavioral activation intervention (Behavioural Intervention)
• Audio-based self-monitoring intervention (Behavioural 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.

Participant Groups

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+

Lindsay A. Rosenwald

Penn State University

Chief Medical Officer since 2013

MD from Temple University School of Medicine

Scott Tarriff

Penn State University

Chief Executive Officer since 2007

B.S. in Marketing from Pennsylvania State University, MBA from Rider College

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Internet-Based Behavioral Activation for Depression: Systematic Review and Meta-Analysis. [2023]

2. United States 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. [2020]

3. Canada pubmed.ncbi.nlm.nih.gov

Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

What is behavioral activation? A review of the empirical literature. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility assessment of a brief, web-based behavioral activation intervention for adolescents with depressed mood. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Treatment failure in behavior therapy: focus on behavioral activation for depression. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial. [2022]