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

57 Participants Needed

Trial Summary

What is the purpose of this trial?

Depression is disabling and affects one in five Veterans. VA's Primary Care-Mental health Integration (PC-MHI) enables specialists to support medication treatment in primary care, but timely and sufficient access to psychotherapy is unattainable despite Veteran preference for psychotherapy. This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting and pilot testing PC-MHI collaborative care models to improve uptake of computerized cognitive behavioral therapy (cCBT).

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.

What data supports the effectiveness of the treatment cCBT Enhanced Collaborative Care for depression?

Research shows that collaborative care models, which involve a team-based approach to treating depression, are effective in improving outcomes for patients with depression and anxiety. These models have been proven to be cost-effective and beneficial in both urban and rural settings. ^{1 2 3 4 5}

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

The research does not specifically address safety concerns for computerized cognitive behavioral therapy (cCBT), but it is widely recognized and recommended as a treatment option for depression, suggesting it is generally considered safe for use in humans. ^{6 7 8 9 10}

How is the treatment cCBT Enhanced Collaborative Care different from other treatments for depression?

cCBT Enhanced Collaborative Care is unique because it uses computerized cognitive behavioral therapy (cCBT) to make therapy more accessible, cost-effective, and convenient by delivering it in a multimedia format. This approach is particularly beneficial for people who may have difficulty accessing traditional therapy, such as those with chronic physical illnesses or older adults. ^{6 7 8 10 11}

Research Team

Lucinda B Leung, MD MPH PhD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of collaborative care for depression in UK primary care (CADET): cluster randomised controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Collaborative care interventions for depression in the elderly: a systematic review of randomized controlled trials. [2018]

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

Cost-effectiveness analysis of a rural telemedicine collaborative care intervention for depression. [2022]

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

Closing the False Divide: Sustainable Approaches to Integrating Mental Health Services into Primary Care. [2022]

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

A Statewide Effort to Implement Collaborative Care for Depression: Reach and Impact for All Patients With Depression. [2018]

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

Is computerized cognitive-behavioural therapy a treatment option for depression in late-life? A systematic review. [2018]

8. 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]

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

Dissemination of computer-assisted cognitive-behavior therapy for depression in primary care. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Computerized cognitive behavioural therapy and the therapeutic alliance: a qualitative enquiry. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

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