Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression

Implementing Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression Among At-Risk Rural and Urban Veterans

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Suicide
• Intervention / Treatment: Behavioral: c-CBT for Suicide Prevention; Behavioral: c-CBT or Depression

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 472
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kelly A Stearns-Yoder, MA; Phone Number: 720-723-6477; Email: Kelly.Stearns@va.gov

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Eastern Colorado Health Care System
      • Contact: Kelly A Stearns-Yoder, MA; Phone Number: 720-723-6477; Email: Kelly.Stearns@va.gov
      • Contact: Lisa A Brenner, PhD; Phone Number: 720-723-6488; Email: Lisa.Brenner@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: c-CBT for Suicide Prevention; CBT for Suicide Prevention	Behavioral: c-CBT for Suicide Prevention; Online c-CBT for SP 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.
Experimental: c-CBT for Depression; Computerized CBT for Depression	Behavioral: c-CBT or Depression; The computerized Cognitive Behavioral Therapy for Depression (cCBT-D) course is comprised of 12 online sessions and is augmented by use of a companion workbook.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire	Acceptability	12 weeks
Internet Evaluation and Utility Questionnaire	Acceptability	12 weeks
Internet Impact and Effectiveness Questionnaire	Acceptability	12 weeks
Narrative Evaluation of Intervention Interview	Acceptability	12 weeks
Recruitment Rate	Number of individuals who consented to participate	12 weeks
Completion of intervention	Number of participants who completed most or all of the sessions	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Scale for Suicide Ideation	Change in suicidal ideation	12 weeks
Patient Health Questionnaire-9	Change in depression symptoms	12 weeks
Posttraumatic Stress Disorder Checklist-5	Change in PTSD symptoms	12 weeks
Generalized Anxiety Disorder-7	Change in anxiety symptoms	12 weeks
Computerized Adaptive Testing - Suicide Scale	Change in suicidal ideation	12 weeks

Collaborators and Investigators

• Sponsor: VA Eastern Colorado Health Care System
• Investigators: Principal Investigator: Lisa A Brenner, PhD, VA Eastern Colorado Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Veterans; Suicide; Cognitive Behavioral Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Behavior; Suicide; Depression
• Other Study ID Numbers: 23-1231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No