Computerized CBT for Depression

(IDMPC Trial)

Overseen By Catherine E Brayton, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Suicide risk, Bipolar, Psychosis, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve access to therapy for Veterans with depression by testing a new method of delivering computerized cognitive behavioral therapy (cCBT). Participants will either receive cCBT with support from a care manager or continue with their usual care. The goal is to make therapy more accessible and effective for individuals struggling with depression. Prospective participants should have depression, access to a computer, and the ability to read English. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in mental health care.

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 seems focused on providing additional therapy rather than changing existing treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that computerized cognitive behavioral therapy (cCBT) can help reduce depression. In a study with 175 adults, cCBT significantly lowered depression levels. However, limited information exists about its safety or possible side effects. Treatment adherence varies widely; some studies report high completion rates, while others show much lower rates. Although cCBT is used to help treat depression and might be considered safe, more information on its safety would be beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about computerized CBT (cCBT) Enhanced Collaborative Care for depression because it uniquely combines digital therapy with personalized support. Unlike traditional medications or face-to-face therapy, cCBT offers a flexible, on-demand treatment option that can be accessed anytime, anywhere. This approach is enhanced by the involvement of a depression care manager, providing a tailored support system alongside standard care. By integrating technology with human interaction, this treatment aims to improve accessibility and engagement, potentially leading to better outcomes for individuals with depression.

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

Research has shown that computerized cognitive behavioral therapy (cCBT) effectively treats depression. Participants in this trial will receive cCBT Enhanced Collaborative Care, which includes support from a depression care manager alongside usual care. Studies have found that cCBT can significantly reduce depression symptoms, similar to traditional therapy with a therapist. One study showed that cCBT improved depression more than usual care, as measured by a standard questionnaire. Reviews of multiple studies confirm that cCBT is as effective as standard therapy for depression. Thus, using a computer for therapy can be just as helpful as seeing a therapist in person. ^{1 2 5 6 7}

Who Is on the Research Team?

Lucinda B Leung, MD MPH PhD

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Are You a Good Fit for This Trial?

This trial is for Veterans with depression who can use a computer, internet, telephone, and email. They must be able to read English on-screen and score at least 10 on the PHQ-9 depression scale. It's not for those with conditions like dementia or terminal illness, high suicide risk or active suicidality, or serious mental illnesses like bipolar disorder or psychosis.

Inclusion Criteria

Score 10 or higher on the PHQ-9

Able to read English text on a computer screen

Have access to computer (mobile or desktop), internet, telephone, and email

Exclusion Criteria

Have medical disorder that would prevent/interfere with participation (e.g. dementia/cognitive impairment, terminal illness)

Have moderate-high suicide risk (e.g., suicide flag) or active suicidality

Have other serious mental illness (e.g. bipolar disorder, psychosis)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided

3 months

Regular virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• cCBT Enhanced Collaborative Care
• Usual Care

Trial Overview The study tests if adding computerized cognitive behavioral therapy (cCBT) to VA's collaborative care improves access to psychotherapy for primary care patients with depression compared to usual care without cCBT.

How Is the Trial Designed?

Group I: cCBT Enhanced Collaborative Care Experimental Treatment 1 Intervention

Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided.

Group II: Usual Care Active Control 1 Intervention

Participants in the usual care arm will receive the usual care provided as described below.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

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]

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 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]

Collaborative care (CC) models significantly improve outcomes for patients with depression and anxiety, as demonstrated by over 80 randomized trials, making them a valuable approach in primary care settings.

CC for depression is not only effective but also cost-effective compared to many treatments for medical disorders, suggesting it could be a sustainable option for managing mental health in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closing the False Divide: Sustainable Approaches to Integrating Mental Health Services into Primary Care. Kroenke, K., Unutzer, J.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16959169/

Computerised cognitive behaviour therapy for depression ... The analysis of these results showed some evidence that CCBT is as effective as therapist-led cognitive behaviour therapy (TCBT) for the treatment of depression ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2788926

Effect of Computer-Assisted Cognitive Behavior Therapy vs ... In this randomized clinical trial of 175 adults, CCBT reduced depression, as measured by the Patient Health Questionnaire–9, to a significantly greater extent ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9039813/

Computerized Cognitive Behavioral Therapy for Treatment ... This meta-analysis reinforces the efficacy of cCBT for the treatment of anxiety and depression and is the first to examine this exclusively in adolescents.

4. nature.com nature.com/articles/s41746-022-00677-8

A systematic review of digital and face-to-face cognitive ... Since its emergence nearly fifty years ago, a large number of studies has underlined the effectiveness of CBT in improving depressive symptoms, ...

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

Computer-Assisted CBT and Mobile Apps for Depression Effectiveness of CCBT for Depression. Results of multiple meta-analyses have confirmed that CCBT is as effective as standard CBT (1, 3–7, 19).

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK269004/

RESULTS - Computerized Cognitive Behavioral Therapy ... Data are lacking on cCBT safety and adverse events. Treatment adherence was reported in 62 percent of comparisons and varied substantially across studies ...

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

Computerized Cognitive Behavioral Therapy for Adults with ... • Data are lacking on cCBT safety and adverse events. • Treatment adherence was reported in 62 percent of comparisons and varied substantially across ...