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Improving Depression Management (IDMPC)

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VA Office of Research and Development

Status

Completed

Conditions

Depression

Treatments

Behavioral: Usual Care
Behavioral: cCBT Enhanced Collaborative Care

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT05050227
CDX 21-004
IK2HX002867 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

Background: VA's Primary Care-Mental Health Integration (PC-MHI) is rooted in evidence-based collaborative care models, where care managers, mental health specialists, and primary care providers jointly treat depression in primary care. While PC-MHI enabled specialists to support medication treatment in primary care, timely and sufficient access to psychotherapy is unattainable. Alternative therapy modalities are needed.

Significance/Impact: Depression is disabling and affects one in five Veterans. Psychotherapy is preferred by Veterans, but fraught with multilevel barriers (e.g., staff availability, patient travel to clinic, limited clinic hours). Without enhancing existing PC-MHI models to enable better primary care patient access to effective psychotherapies, Veteran engagement in depression treatment is unlikely to improve.

Innovation: This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting PC-MHI collaborative care models to improve uptake of computerized cognitive behavioral therapy (cCBT). cCBT is accessible 24/7 via the internet and has effectively treated depression in more than 30 trials. With modest specialist support, it is non-inferior to face-to-face psychotherapy. PC-MHI can facilitate Veteran uptake of cCBT, using an evidence-based collaborative care model to provide the follow-up care management and mental health specialist back-up that characterizes the most effective cCBT trials.

Specific Aims/Methodology: To pilot test the feasibility, acceptability, and potential effects of cCBT-enhanced collaborative care on Veterans' depression symptoms and related outcomes in VA Greater Los Angeles Healthcare System. A pilot randomized controlled trial (RCT) will be conducted to examine feasibility, acceptability, and potential effects on depression, patient activation, and health-related quality of life in VA primary care patients with depression receiving either (1) cCBT-enhanced collaborative care (n=37) or (2) usual care (n=37) in West Los Angeles VA, from baseline to 3-months (post-intervention).

Next Steps/Implementation: Adapting PC-MHI's collaborative care model to incorporate cCBT can improve access to psychotherapy and engage the ~400,000 untreated Veterans with depression who prefer psychotherapy, especially OIF/OEF/OND Veterans seeking care that is convenient.

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Have access to computer (mobile or desktop), internet, telephone, and email
  • Able to read English text on a computer screen
  • Score 10 or higher on the PHQ-9

Exclusion criteria

  • Have moderate-high suicide risk (e.g., suicide flag) or active suicidality
  • Have other serious mental illness (e.g. bipolar disorder, psychosis)
  • Have medical disorder that would prevent/interfere with participation (e.g. dementia/cognitive impairment, terminal illness)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

57 participants in 2 patient groups

cCBT Enhanced Collaborative Care
Experimental group
Description:
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.
Treatment:
Behavioral: cCBT Enhanced Collaborative Care
Usual Care
Active Comparator group
Description:
Participants in the usual care arm will receive the usual care provided as described below.
Treatment:
Behavioral: Usual Care

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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