Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression

NCT ID: NCT06375083

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

472 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2025-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Suicide Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Cognitive Behavioral Therapy for Suicide Prevention (cCBT-SP) and Cognitive Behavioral Therapy for Depression (cCBT-D)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive Behavioral Therapy

Online (computerized) CBT for Depression or Suicide Prevention

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

The computerized Cognitive Behavioral Therapy for Suicide Prevention (cCBT-SP) course is comprised of 12 online sessions and is augmented by use of a companion workbook. The computerized Cognitive Behavioral Therapy for Depression (cCBT-D) course is comprised of 12 online sessions.

Interventions

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Cognitive Behavioral Therapy

The computerized Cognitive Behavioral Therapy for Suicide Prevention (cCBT-SP) course is comprised of 12 online sessions and is augmented by use of a companion workbook. The computerized Cognitive Behavioral Therapy for Depression (cCBT-D) course is comprised of 12 online sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


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. 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


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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Eastern Colorado Health Care System

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa A Brenner, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Eastern Colorado Health Care System

Locations

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Eastern Colorado Health Care System

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kelly A Stearns-Yoder, MA

Role: CONTACT

720-723-6477

Facility Contacts

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Lisa A Brenner, PhD

Role: primary

720-723-6488

Kelly A Stearns-Yoder, MA

Role: backup

720-723-6477

Other Identifiers

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23-1231

Identifier Type: -

Identifier Source: org_study_id

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