Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression

VA Eastern Colorado Health Care System

Status and phase: Enrolling; Phase 2

Conditions: Depression; Suicide

Treatments: Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06375083

23-1231

Details and patient eligibility

About

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.

Full description

Based on previous work with other computerized CBT (cCBT) interventions (e.g., cCBT-D), which has found that cCBT has similar effectiveness to traditional CBT, members of the team along with Veterans Health Administration (VHA) leaders have developed computerized cCBT-SP and cCBT-D courses that will be ready for safety, feasibility, and acceptability testing. If proven to be feasible, safe, and effective, these courses could be made available to all Veterans, at no cost to users.

Enrollment: 472 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Cohort A - cCBT-SP Program

Inclusion Criteria:

1. Veterans between the ages of 18 and 65
2. Currently living in Colorado, New York, Montana, Texas, or Utah who have accessed VA Care
3. Recent suicidal ideation (past month; C-SSRS Screener -Yes to Item 2) and history of lifetime suicidal behavior (lifetime, C-SSRS Screener - Yes to Item 6)
4. Reliable access to a computer/tablet and the internet
5. Ability to provide informed consent

Exclusion Criteria:

1. Active alcohol or substance use disorder, excluding Cannabis dependence, as determined by screening or electronic medical record
2. Identification of active psychosis or bipolar disorder, as determined via screening or electronic medical record
3. Severe cognitive impairment, as determined by screening or electronic medical record
4. Currently enrolled in/participating in another mental health-related intervention research study

Cohort B - cCBT-D Program

Inclusion Criteria:

1. Veterans between the ages of 18 and 65
2. Currently living in Colorado, New York, Montana, Texas, or Utah who have accessed VA care
3. Mild to moderate depressive symptoms, as determined by the PHQ-9, (score of 5-14)
4. Reliable access to a computer/tablet and the internet
5. Ability to provide informed consent

Exclusion Criteria:

1. PHQ-9 score below 4 or 15 and above
2. Active alcohol or substance use disorder, excluding Cannabis dependence, as determined by screening or electronic medical record
3. Identification of active psychosis or bipolar disorder, as determined via screening or electronic medical record
4. Severe cognitive impairment, as determined by screening or electronic medical record
5. Currently enrolled in/participating in other intervention research study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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472 participants in 1 patient group

Cognitive Behavioral Therapy

Experimental group

Description:

Online (computerized) CBT for Depression or Suicide Prevention

Treatment:

Behavioral: Cognitive Behavioral Therapy