Cognitive Behavioral Therapy for Depression and Suicide Prevention

Overseen By Kelly A Stearns-Yoder, MA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Eastern Colorado Health Care System

Disqualifiers: Alcohol, Substance use, Psychosis, Bipolar, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

472 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of two self-guided online cognitive behavioral therapy (CBT) courses for veterans. One course targets reducing symptoms of depression, while the other addresses past suicidal thoughts and behaviors. Veterans in Colorado, New York, Montana, Texas, or Utah who have accessed VA care and meet specific mental health criteria may qualify. Participants need reliable internet and a computer or tablet to access the therapy. The study aims to discover new ways to support mental health through accessible online resources. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering veterans a chance to contribute to potentially impactful mental health solutions.

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 healthcare provider.

What prior data suggests that these computerized cognitive behavioral therapies are safe?

Research has shown that computerized cognitive behavioral therapy (CBT) is generally safe and well-received by patients. Studies have found that online CBT effectively lessens symptoms of depression and reduces thoughts of self-harm. Specifically, evidence indicates that internet-based CBT significantly decreases suicidal thoughts.

Regarding safety, existing studies have reported no major negative effects. This indicates that people using these online programs did not experience serious side effects. Research on computerized CBT for reducing depression and anxiety further supports its safety for these issues.

Overall, available research suggests that computerized CBT is a safe option for those dealing with depression and suicidal thoughts. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for depression and suicide prevention, like traditional cognitive behavioral therapy (CBT), involve face-to-face sessions with a therapist. However, the computerized CBT being studied is unique because it's delivered online, making it accessible to people who might not have easy access to in-person therapy due to location, mobility, or time constraints. Researchers are excited about this treatment because it offers the potential for greater reach and flexibility, allowing more people to get help on their own schedule. Additionally, the digital format can be cost-effective, potentially reducing the financial barriers to receiving mental health care.

What evidence suggests that these computerized cognitive behavioral therapies are effective for depression and suicide prevention?

Research has shown that computerized cognitive behavioral therapy (CBT), which participants in this trial will receive, effectively treats depression and suicidal thoughts. Studies have found that online CBT can greatly reduce suicidal thoughts and attempts. One study found that digital CBT works well for people of all ages and backgrounds. Another study confirmed that computerized CBT is as effective as traditional in-person therapy for treating depression. These findings suggest that CBT delivered online can be a powerful tool for improving mental health. ^{1 2 4 6 7}

Who Is on the Research Team?

Lisa A Brenner, PhD

Principal Investigator

VA Eastern Colorado Health Care System

Are You a Good Fit for This Trial?

This trial is for individuals experiencing depression or having a history of suicidal thoughts and behaviors. Participants will engage in self-guided online cognitive behavioral therapy courses designed to address these issues.

Inclusion Criteria

Reliable access to a computer/tablet and the internet

I am a veteran aged between 18 and 65.

Currently living in Colorado, New York, Montana, Texas, or Utah who have accessed VA Care

Exclusion Criteria

Currently enrolled in/participating in another mental health-related intervention research study

Identification of active psychosis or bipolar disorder, as determined via screening or electronic medical record

Severe cognitive impairment, as determined by screening or electronic medical record

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in self-guided online cognitive behavioral therapy courses focused on depression or suicidal thoughts and behaviors

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Computerized Cognitive Behavioral Therapies

Trial Overview

The study is testing two different self-guided online cognitive behavioral therapy (CBT) courses: one tailored for managing symptoms of depression, and the other focused on coping with suicidal thoughts and behaviors.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

Online (computerized) CBT for Depression or Suicide Prevention

Who Is Running the Clinical Trial?

VA Eastern Colorado Health Care System

Lead Sponsor

Trials

55

Recruited

26,200+

Published Research Related to This Trial

Computerized cognitive behavior therapy (cCBT) shows potential as an effective treatment for depression in individuals with chronic physical health problems, based on a systematic review of randomized controlled trials, although only one study specifically focused on diabetes was included.

The single study indicated positive outcomes compared to a waiting-list control, but it also faced challenges such as high participant dropout rates, suggesting that cCBT may not be acceptable to all and highlighting the need for more comprehensive research to confirm its efficacy and feasibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive behaviour therapy for depression in people with a chronic physical illness. Sharp, J., Holly, D., Broomfield, N.[2018]

A systematic review of 29 studies on computerized cognitive behavioral therapy (cCBT) for depression found that user acceptance is generally high, with 8 studies reporting very high acceptance and 17 reporting high acceptance levels.

Despite the positive reception of cCBT, the review highlighted significant methodological issues in how user acceptance was measured and defined, indicating a need for clearer operationalization in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Acceptance of Computerized Cognitive Behavioral Therapy for Depression: Systematic Review. Rost, T., Stein, J., Löbner, M., et al.[2018]

An Internet-based computerized cognitive behavioral therapy (CCBT) program significantly improved depression and anxiety symptoms in unemployed men at risk of depression, with greater improvements observed in participants using physiological sensors compared to those who did not.

Participants reported high levels of satisfaction and usability with the CCBT program, scoring an average of 88 out of 100, indicating that the program is not only effective but also well-received and easy to use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-based program for depression using activity and physiological sensors: efficacy, expectations, satisfaction, and ease of use. Botella, C., Mira, A., Moragrega, I., et al.[2022]

Computerised cognitive behaviour therapy (cCBT) has been shown to effectively reduce depressive symptoms, comparable to face-to-face therapy, and is more effective than waiting lists or standard treatment.

This study will explore how different types of human support (brief vs. extended, expert vs. assistant) impact the effectiveness and acceptability of cCBT, using a sample of 200 adults with non-suicidal depression to ensure robust results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised therapy for depression with clinician vs. assistant and brief vs. extended phone support: study protocol for a randomised controlled trial. Gega, L., Swift, L., Barton, G., et al.[2021]

A pilot study involving 196 primary care patients found that 20% enrolled in an Internet-delivered cognitive behavioral therapy (CBT) program, indicating that integrating such programs into healthcare systems is feasible.

Participants who completed the program experienced a significant average reduction of 46% in depressive symptoms after four months, along with a decrease in suicidal thoughts, suggesting that Internet-delivered CBT can be an effective treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project. Whiteside, U., Richards, J., Steinfeld, B., et al.[2021]

In a randomized clinical trial involving 175 primary care patients with depression, clinician-supported computer-assisted cognitive behavior therapy (CCBT) significantly improved depressive symptoms compared to treatment as usual (TAU) at posttreatment and follow-up points (3 and 6 months).

CCBT was particularly effective in a diverse population, including many low-income individuals with limited internet access, suggesting it can be a valuable treatment option in primary care settings where traditional therapy may be less accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Computer-Assisted Cognitive Behavior Therapy vs Usual Care on Depression Among Adults in Primary Care: A Randomized Clinical Trial. Wright, JH., Owen, J., Eells, TD., et al.[2022]

A digital mental health program providing internet-based cognitive behavioral therapy (iCBT) was successfully implemented in primary care, with 2,228 patients prescribed the program and nearly 49% enrolling, indicating good acceptance among patients.

Patients who engaged with the iCBT program showed significant clinical improvements, with a 23% reduction in depression scores (PHQ-9) and a 26% reduction in anxiety scores (GAD-7), demonstrating the efficacy of digital tools in treating mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. Sharif-Sidi, Z., Shen, C., Wong, W., et al.[2021]

Citations

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The current evidence indicates that iCBT is effective in reducing suicidal ideation irrespective of age, gender and previous suicide attempts.

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These results show that iCBT interventions are associated with significant reductions in suicidal ideation compared with control conditions.

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psychiatryonline.org/doi/10.1176/appi.focus.20190044

Computer-Assisted CBT and Mobile Apps for Depression

Results of multiple meta-analyses have confirmed that CCBT is as effective as standard CBT (1, 3–7, 19). For example, a recent systematic review ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7189224/

Internet-Based Cognitive Behavioral Therapy to Reduce ...

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hsrd.research.va.gov

hsrd.research.va.gov/publications/esp/cognitive.pdf

Computerized Cognitive Behavioral Therapy for Adults with ...

Computerized Cognitive Behavioral Therapy for Adults With Depressive or Anxiety Disorders. VA-ESP Project #09-010; 2013. This report is based on research ...