Psychological Care Strategies for Depression and Anxiety

Overseen By Amelia Welborn, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Psychotic disorder, Severe eating disorder, Severe substance use disorder, Severe neurological disorder, others

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

Compensation: Varies

Number of Visits: 8

Duration: 40 weeks

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how to best match mental health care to the needs of community college students dealing with depression and anxiety. It will test two methods: one that uses current symptoms to decide care and another that considers broader life factors. Participants might receive different types of care, ranging from self-guided online programs to one-on-one sessions with a therapist (clinician-delivered psychological and psychiatric care). Students at East Los Angeles College with internet access and either no insurance or Medicaid may qualify. The study aims to determine which approach helps students feel better over the 40-week period.

As an unphased trial, this study offers a unique opportunity to contribute to research that could improve mental health care for students.

Do I have to stop taking my current medications for the trial?

The protocol does not specify whether you need to stop taking your current medications. However, if you are currently treated by a psychiatrist or psychologist, you must be willing to fully transfer your care to the trial's program.

What prior data suggests that these clinical decision-making algorithms are safe for mental health care?

Research shows that the treatments in this trial are generally safe for people.

For mental health care provided by professionals, studies have found that telehealth treatments are as safe and effective as in-person meetings. Many people feel comfortable and secure in these online settings, which helps them open up more easily.

Online cognitive behavioral therapy (CBT) with a coach is also well-received. Research has shown that people using online CBT with a therapist's help often recover well, especially from depression. This method is both effective and safe for treating mental health issues.

Self-guided online prevention methods have been studied as well. One study found that a self-guided digital program for anxiety and depression was effective and safe. People could use these programs on their own to manage their symptoms without major safety concerns.

Overall, these treatments are safe and have been used in various settings without significant negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these techniques for managing depression and anxiety because they offer a fresh approach to personalizing mental health care. Unlike traditional methods that often rely on a one-size-fits-all strategy, these new methods use data-driven algorithms to tailor treatment based on individual factors like social determinants, early life stress, and comprehensive mental health status. This approach aims to optimize the level of care each person receives, potentially improving outcomes by being more responsive to individual needs. Additionally, the use of online cognitive behavioral therapy, whether guided by a coach or self-directed, provides greater accessibility and flexibility compared to conventional in-person therapy sessions.

What evidence suggests that this trial's treatments could be effective for depression and anxiety?

Research has shown that care provided by doctors and therapists, available to participants in this trial, can significantly aid in addressing mental health issues like depression and anxiety. Studies found that 39% of patients who received treatment improved, compared to 24% who did not. Coach-guided online cognitive behavioral therapy (CBT), another treatment option in this trial, has proven effective, especially with therapist involvement, leading to better recovery rates for depression. Evidence suggests that self-guided online programs, also under study in this trial, can effectively prevent depression and reduce anxiety symptoms. Each method offers promising results for managing mental health, with varying levels of support to meet individual needs. ^{2 4 5 6 7}

Who Is on the Research Team?

Michelle G. Craske, Ph.D

Principal Investigator

University of California, Los Angeles

Kate Taylor, Ph.D

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for students aged 18-40 at East Los Angeles College, either uninsured or on California Medicaid, with internet access. It's not for those needing specialized care for severe disorders, currently under psychiatric treatment unwilling to transfer to STAND, or unable to understand the study requirements.

Inclusion Criteria

Own or have private access to internet to complete the assessments and online prevention and therapy programs

I am either uninsured or covered by California Medicaid.

Currently enrolled in the East Los Angeles College

Exclusion Criteria

I can understand the consent form and answer questions about my health.

I am seeing a psychiatrist or psychologist and do not want to switch to STAND.

Diagnosed with disorders requiring more specialized care (e.g., psychotic disorder, severe eating disorder, severe substance use disorder, severe neurological disorder), or marked cognitive impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into symptom severity decision-making or data-driven decision-making and triaged to one of three levels of care. Treatment includes self-guided online prevention, coach-guided online cognitive behavioral therapy, or clinician-delivered care.

40 weeks

Weekly or every 8 weeks assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinician-Delivered Psychological and Psychiatric Care
• Coach-Guided Online Cognitive Behavioral Therapy
• Self-Guided Online Prevention

Trial Overview The S.T.A.N.D. project tests decision-making algorithms in triaging and adapting mental health care levels among diverse low-income college students. They'll be randomly assigned to symptom severity or data-driven groups and receive varying online prevention and therapy services.

How Is the Trial Designed?

Group I: Data-Driven Decision-Making Experimental Treatment 3 Interventions

Using data-driven algorithm that considers social determinants of mental health, early life adversity/stress, predisposing, enabling and need influences upon health services use, and comprehensive mental health status to guide triaging and adapting level of care.

Group II: Symptom Severity Decision-Making Active Control 3 Interventions

Using current symptom severity level to guide triaging and adapting level of care.

Clinician-Delivered Psychological and Psychiatric Care is already approved in United States, European Union for the following indications:

Approved in United States as Psychological and Psychiatric Care for:

• Depression
• Anxiety
• Mental Health Disorders

Approved in European Union as Psychological and Psychiatric Care for:

• Mental Health Disorders
• Psychological Distress

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

The 'Improvehealth.eu' eHealth service was successfully implemented in a pilot study with 46 patients, showing a significant improvement in medication adherence for those using the intervention (odds ratio = 10.0, P = .03).

Patients using the eHealth service reported feeling more engaged and in control of their treatment, with 81% expressing positive perceptions, suggesting the intervention has potential to enhance treatment outcomes for depressive disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an eHealth service to support collaborative depression care: results of a pilot study. Meglic, M., Furlan, M., Kuzmanic, M., et al.[2021]

In a study involving 229 patients with generalized anxiety disorder, an internet-delivered psychotherapy program showed a significant reduction in anxiety symptoms, as measured by the GAD-7 scale, indicating its efficacy in real-world primary care settings.

Despite the program's effectiveness, only 13.5% of participants completed it, with withdrawal linked to factors like low program friendliness and lack of motivation, highlighting the need to address these barriers for better engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and pattern of use of a computer-assisted programme for the treatment of anxiety: a naturalistic study using mixed methods in primary care in Spain. Herrera-Mercadal, P., Montero-Marin, J., Plaza, I., et al.[2018]

Digital apothecaries, proposed as online repositories for evidence-based psychological interventions, could significantly improve access to mental health resources for individuals globally, especially those currently underserved.

While these digital tools have the potential to reduce health disparities, there is a caution against their misuse, which could lead to reduced access to traditional in-person care, highlighting the need for mindful integration into healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital apothecaries: a vision for making health care interventions accessible worldwide. Muñoz, RF., Chavira, DA., Himle, JA., et al.[2023]

The rise of technology and consumer choice is transforming mental health treatment, allowing individuals to choose between traditional in-person consultations and various online services for diagnosis and support.

The paper reviews the effectiveness and ethical considerations of computer programs in treating anxiety and depression, highlighting the potential for structured therapy programs and online counseling to improve access to mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based treatment for anxiety and depression: is it feasible? Is it effective? Proudfoot, JG.[2019]

The study involving 594 patients showed that implementing computerized outcome feedback (OF) technology in therapy for depression and anxiety did not significantly change clinical outcomes, as measured by PHQ-9 and GAD-7 scores, compared to traditional methods.

However, the use of OF led to a significant reduction in the average duration and cost of treatment, suggesting that OF can enhance the efficiency of stepped care psychological services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the efficiency of psychological treatment using outcome feedback technology. Delgadillo, J., Overend, K., Lucock, M., et al.[2018]

A study involving 2233 patients and 79 therapists across eight NHS Trusts found that using an outcome feedback system in psychological therapy significantly reduced symptom severity in patients at risk of poor treatment response, compared to standard treatment.

Patients receiving therapy with outcome feedback showed greater improvements in depression and anxiety scores, indicating that this low-cost technology can enhance the effectiveness of psychological interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feedback-informed treatment versus usual psychological treatment for depression and anxiety: a multisite, open-label, cluster randomised controlled trial. Delgadillo, J., de Jong, K., Lucock, M., et al.[2019]

This study will evaluate the effectiveness of a cognitive-behavioral therapy (CBT) intervention delivered by primary care psychologists to 246 patients with mild-to-moderate mixed anxiety-depressive disorder, comparing it to usual care alone.

The primary outcome will be measured using the Short Form-36 General Health Survey, with additional assessments of anxiety and depression symptoms at multiple time points, highlighting the potential benefits of integrating psychological interventions in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a cognitive and behavioural psychotherapy applied by primary care psychologists in patients with mixed anxiety-depressive disorder: a research protocol. Jauregui, A., Ponte, J., Salgueiro, M., et al.[2018]

In a randomized controlled trial involving 63 participants referred to secondary mental health care for depression, the addition of a coach to a Web-based therapy (The Journal) did not significantly improve depression scores compared to usual care with an information leaflet after 12 weeks.

Participants using The Journal attended fewer outpatient appointments on average, but this difference was not statistically significant, highlighting potential challenges in engagement and adherence to Web-based therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based Therapy Plus Support by a Coach in Depressed Patients Referred to Secondary Mental Health Care: Randomized Controlled Trial. Hatcher, S., Whittaker, R., Patton, M., et al.[2020]

A pilot study involving 38 primary care providers in Vermont showed that a 1-hour training workshop for ultra-brief cognitive-behavioral therapy (UB-CBT) was highly feasible and acceptable, with 91% of providers feeling adequately trained to use the intervention.

Providers reported that the UB-CBT intervention was easy to administer (97% agreement), although some expressed concerns about the time required for implementation, indicating a need for further refinement and research on its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-brief cognitive-behavioral therapy (for routine primary care visits: Feasibility and acceptability of a brief provider training workshop. Terman, JM., Rohan, KJ., Cruz, RC., et al.[2023]

In a study involving 282 anxious adults, a low-intensity coaching protocol was developed to support engagement in a web-based cognitive bias modification intervention, but about half of the participants did not respond to coaching attempts.

Despite the challenges, around 30% of participants completed the intervention with their coach, suggesting that while coaching can help, many anxious individuals may prefer technology-based interventions without direct human contact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned: Providing Supportive Accountability in an Online Anxiety Intervention. Werntz, A., Silverman, AL., Behan, H., et al.[2023]

The Patients First initiative uses the CareSense platform to combine patient-reported outcomes with biological monitoring, allowing for real-time feedback on symptoms like stress, anxiety, and depression, which enhances patient engagement and care delivery.

This project is pioneering in integrating digital therapeutics and providing video resources to primary care providers, enabling them to respond effectively when patients show signs of symptom severity, marking a significant advancement in psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Psychiatric Care Through Integrated Digital Technologies. Fowler, JC., Madan, A., Bruce, CR., et al.[2023]

Digital media and electronic health systems can effectively assess and monitor both somatic and psychiatric disorders by collecting real-world data on symptoms, wellbeing, and physiological indicators over time.

For online interventions to be successful, patients require motivation and support from therapists, highlighting the need for mental health professionals to become proficient in using digital tools to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[E-Health in diagnosis and therapy of mental disorders : Will therapists soon become superfluous?] Lüttke, S., Hautzinger, M., Fuhr, K.[2019]

Citations

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3. sciencedirect.com sciencedirect.com/science/article/pii/S0165032723006389

Psychological treatment of depression: A systematic ... We found an overall response rate of 39 % in the treatment and 24 % in the control conditions (NNT = 6.2). Clinically significant improvement ...

4. apa.org apa.org/monitor/2024/01/trends-pathways-access-mental-health-care

Mental health care is in high demand. Psychologists are ... Amid a shortage of mental health providers, digital therapeutics could play an important role in providing support for underserved communities.

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Effectiveness of General Practitioner Referral Versus Self ... Conclusions: Self-referral to guided ICBT for depression and PD appears to yield greater treatment outcomes compared to GP referrals. We found ...

6. withpower.com withpower.com/trial/phase-anxiety-disorders-7-2022-47f5d

Psychological Care Strategies for Depression and Anxiety The research provided does not directly address safety data for the psychological care strategies mentioned. However, it discusses various aspects of digital ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK586283/

Evidence Brief: Safety and Effectiveness of Telehealth ... - NCBI Results of most studies found telehealth delivery of mental health care comparable to in-person delivery.