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

Trial Summary

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 data supports the effectiveness of the treatment Computerized Cognitive Behavioral Therapies for depression and suicide prevention?

Research shows that Computerized Cognitive Behavioral Therapy (CCBT) is effective in treating depression, with studies indicating improvements in depression scores and high user acceptance. CCBT has been used successfully for depression and anxiety, suggesting it could also help with related issues like suicide prevention. ^{1 2 3 4 5}

Is computerized cognitive behavioral therapy (cCBT) safe for humans?

The research does not specifically mention safety concerns for computerized cognitive behavioral therapy (cCBT), suggesting it is generally considered safe for humans when used for depression. ^{1 2 6 7 8}

How is the treatment Computerized Cognitive Behavioral Therapies (cCBT) for depression and suicide prevention different from other treatments?

Computerized Cognitive Behavioral Therapies (cCBT) are unique because they are delivered via computer, making them more accessible and convenient than traditional face-to-face therapy. They offer a standardized, interactive self-help program that can be as effective as in-person therapy, and they can be enhanced with sensors to monitor physiological and activity data, potentially improving outcomes. ^{1 2 4 6 7}

What is the purpose of this trial?

This study plans to learn more about the use of one of two self-guided online cognitive behavioral therapy courses. One is focused on symptoms of depression and one is focused on history of suicidal thoughts and behaviors.

Research Team

Lisa A Brenner, PhD

Principal Investigator

VA Eastern Colorado Health Care System

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

An Internet-based program for depression using activity and physiological sensors: efficacy, expectations, satisfaction, and ease of use. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

User Acceptance of Computerized Cognitive Behavioral Therapy for Depression: Systematic Review. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. [2021]

4. United States 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. [2022]

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

Computer-assisted cognitive-behavioral therapy. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Computerized cognitive behaviour therapy for depression in people with a chronic physical illness. [2018]

7. England 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. [2021]

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

Online cognitive behavioral therapy for depressed primary care patients: a pilot feasibility project. [2021]