Behavioral Telehealth for Youth Anxiety and Depression

(STEP-UP Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Must not be taking: Lithium, Antipsychotics

Disqualifiers: PTSD, Suicidal ideation, Substance dependence, others

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

Compensation: Varies

Number of Visits: 32

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new telehealth program called STEP-UP (Support, Training, and Education for Pain Self-Management Using Podcasts) designed to help children and teens (ages 8 to 16) with anxiety and depression. It compares this program to standard community mental health care to determine which is more effective in improving daily life and reducing anxiety and depression symptoms. Youths diagnosed with anxiety (such as social or generalized anxiety) or depression and treated at participating community health centers may be suitable candidates. The trial includes interviews before treatment begins and again at 16 and 24 weeks to monitor participants' progress. As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health solutions for young people.

Will I have to stop taking my current medications?

The trial requires that participants have been on a stable dose of any psychotropic medication for at least 8 weeks before starting, or have stopped taking it for at least 4 weeks. If you are taking lithium or an anti-psychotic medication, you cannot participate in the trial.

What prior data suggests that this behavioral telehealth treatment is safe for youth?

A previous study demonstrated that the STEP-UP program helped people manage long-term pain. This program included online resources and support from a community health worker. Research has shown that these types of online health programs are usually well-received. No major reports of serious side effects or safety issues emerged.

The current trial tests STEP-UP to help young people with anxiety and depression. Since this trial is in the "Not Applicable" phase, researchers focus on the program's effectiveness rather than testing a new drug. The program's past use in other conditions, like chronic pain, supports its safety, with no major negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STEP-UP program because it offers a fresh approach to tackling youth anxiety and depression through behavioral telehealth. Unlike traditional face-to-face therapy, which can be hard to access for many young people, STEP-UP delivers mental health support remotely, making it more convenient and accessible. This method leverages technology to reach youth in the comfort of their homes, potentially reducing barriers to treatment like transportation and scheduling conflicts. By focusing on accessibility and using digital tools, STEP-UP aims to engage youth in their mental health care more effectively, which could lead to better outcomes.

What evidence suggests that STEP-UP might be an effective treatment for youth anxiety and depression?

Research has shown that the STEP-UP program, one of the treatments in this trial, can greatly help with anxiety and depression. Specifically, past participants experienced significant improvements in their overall health, with fewer symptoms of depression and anxiety. The program is offered online, making it more accessible for families. Support and education have been crucial in helping young people manage their symptoms better. These findings suggest that STEP-UP could effectively improve the daily lives and mental health of children and teenagers dealing with anxiety and depression. Another treatment arm in this trial is the ARC program, which serves as an active comparator. ^{1 2 3 4 6}

Who Is on the Research Team?

V. Robin Weersing, PhD

Principal Investigator

San Diego State University

Frances Lynch, PhD

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for English-speaking youths aged 8-16 with anxiety or depression, who live with a consenting guardian over half the time and are patients at participating health centers. Guardians must speak English or Spanish. It's not suitable for those outside these criteria.

Inclusion Criteria

I have been diagnosed with or show signs of significant anxiety or depression.

Youth is a patient in a participating community health center

Youth speaks English

Exclusion Criteria

Youth is placed in a special education program for greater than 50% of the school day and/or youth school placement is below the second-grade level at baseline

I am currently receiving treatment for anxiety or depression besides this study.

My psychotropic medication dose has been unstable for less than 8 weeks or stopped for less than 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the STEP-UP telehealth treatment program or are referred to community mental health services

16 weeks

Interviews at baseline, 16 weeks, and 24 weeks

Follow-up

Participants are monitored for changes in anxiety and depression symptoms and overall functioning

8 weeks

Follow-up assessments at 16 weeks and 32 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STEP-UP

Trial Overview

The study tests STEP-UP, a telehealth program for treating youth anxiety and depression, against usual mental health services from community clinicians. Participants will be randomly assigned to either receive STEP-UP through their health center or get referred to local care.

How Is the Trial Designed?

Group I: STEP-UP Experimental Treatment 1 Intervention

Group II: ARC Active Control 1 Intervention

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

OCHIN, Inc.

Collaborator

Trials

24

Recruited

9,964,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A systematic review of 17 randomized controlled trials involving 2503 patients found that Internet-based cognitive and behavioral therapy interventions significantly improved pain and activity limitations, with 77.8% of studies showing positive outcomes.

While there is promising evidence for Internet-based peer support programs and social networking in reducing pain, the overall effectiveness varies, and more high-quality studies are needed to determine which patient groups benefit the most.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can pain be managed through the Internet? A systematic review of randomized controlled trials. Bender, JL., Radhakrishnan, A., Diorio, C., et al.[2022]

Chronic pain affects many people and comes with high costs, but access to effective behavioral interventions is limited due to barriers like a shortage of trained clinicians and inadequate insurance coverage.

Recent technological advancements present new opportunities to improve access to evidence-based pain education and treatments for both children and adults, potentially overcoming existing challenges in the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative treatment formats, technologies, and clinician trainings that improve access to behavioral pain treatment for youth and adults. Darnall, BD., Edwards, KA., Courtney, RE., et al.[2023]

A digital health intervention, the WebMAP Mobile app, was evaluated in a study involving 143 youth aged 10 to 17 with chronic pain, showing that participants perceived greater improvements in their condition compared to those receiving usual care.

While the intervention was found to be acceptable to parents, youth, and providers, only about 30% completed the treatment, indicating a need for further research to enhance engagement and optimize implementation of digital health solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital health psychological intervention (WebMAP Mobile) for children and adolescents with chronic pain: results of a hybrid effectiveness-implementation stepped-wedge cluster randomized trial. Palermo, TM., de la Vega, R., Murray, C., et al.[2022]

Citations

1.

sph.umich.edu

sph.umich.edu/step-up/

Support, Training, and Education for Pain Self ...

STEP-UP is an innovative chronic pain self-management program delivered through a workbook and online resources and coached by a community health worker.

2.

withpower.com

withpower.com/trial/phase-chronic-pain-1-2024-9a1c9

STEP-UP Program for Chronic Pain · Info for Participants

Participants experienced significant improvements in patient activation, health status, and reductions in depression, anxiety, and pain severity, indicating the ...

3.

withpower.com

withpower.com/trial/phase-anxiety-disorders-6-2024-53132

Behavioral Telehealth for Youth Anxiety and Depression (STEP ...

The main question the study aims to answer is whether STEP-UP improves youths functioning in daily life, anxiety symptoms, and depression symptoms. Researchers ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11472369/

Podcasts as a tool for promoting health-related behaviours

Podcasts are a popular medium for delivering health-related content, potentially influencing physical and mental health behaviours and outcomes.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10397413/

Innovative treatment formats, technologies, and clinician ...

We review several promising new pediatric and adult pain education and treatment technology innovations to improve access and scalability of evidence-based ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S1526590023005977

We Are All in This Together—Whole of Community Pain ...

Pain Science Education improves understanding of 'how pain works' and has been demonstrated to improve pain and disability outcomes.