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

220 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment STEP-UP for youth anxiety and depression?

Research on similar digital health interventions for chronic pain, like WebMAP Mobile, shows that youth perceive greater improvement in their condition when using these tools. Additionally, internet-based cognitive and behavioral therapy has shown promise in improving anxiety and depression, suggesting that STEP-UP could be effective for these conditions as well. ^{1 2 3 4 5}

Is the digital health intervention for youth anxiety and depression safe?

The digital health interventions, like WebMAP, have been used safely in children and adolescents with chronic pain, showing improvements in pain and disability without significant safety concerns. ^{1 2 6 7 8}

How is the STEP-UP treatment for youth anxiety and depression different from other treatments?

The STEP-UP treatment is unique because it uses podcasts to deliver support, training, and education for managing anxiety and depression, making it more accessible and convenient compared to traditional in-person therapy sessions. ^{1 9 10 11 12}

What is the purpose of this trial?

The goal of this clinical trial is to test a brief, behavioral telehealth treatment program (STEP-UP) for depression and anxiety in youths (age 8-16 years old). Youths and families will be recruited through participating community health centers and will be randomly assigned to either: (a) receive STEP-UP care from providers at their health center or (b) be referred to care from local community mental health clinicians. Youth and families will be interviewed before treatment starts, 16 weeks later, and 24 weeks later to assess how youth are feeling. The main question the study aims to answer is whether STEP-UP improves youths functioning in daily life, anxiety symptoms, and depression symptoms. Researchers will compare STEP-UP to referral to community treatment-as-usual mental health services to see if STEP-UP is more effective.

Research Team

Frances Lynch, PhD

Principal Investigator

Kaiser Permanente

V. Robin Weersing, PhD

Principal Investigator

San Diego State University

Eligibility Criteria

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

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States 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. [2022]

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

Online psychological treatment for pediatric recurrent pain: a randomized evaluation. [2022]

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

Development and implementation of a telehealth-enhanced intervention for pain and symptom management. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

TelePain: Primary Care Chronic Pain Management through Weekly Didactic and Case-based Telementoring. [2020]

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

Can pain be managed through the Internet? A systematic review of randomized controlled trials. [2022]

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

Mobile health intervention for self-management of adolescent chronic pain (WebMAP mobile): Protocol for a hybrid effectiveness-implementation cluster randomized controlled trial. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Innovative treatment formats, technologies, and clinician trainings that improve access to behavioral pain treatment for youth and adults. [2023]

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

The pain course: a randomised controlled trial comparing a remote-delivered chronic pain management program when provided in online and workbook formats. [2018]

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

Brief report: Web-based management of adolescent chronic pain: development and usability testing of an online family cognitive behavioral therapy program. [2021]

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

In-Person Versus Telehealth for Concussion Clinical Care in Adolescents: A Pilot Study of Therapeutic Alliance and Patient Satisfaction. [2023]

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

A Nationally Scaled Telebehavioral Health Program for Chronic Pain: Characteristics, Goals, and Psychological Outcomes. [2018]

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

Randomized controlled trial of an Internet-delivered family cognitive-behavioral therapy intervention for children and adolescents with chronic pain. [2022]