Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression

Phase 2

Recruiting

• Conditions: Depression; Suicide
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT06375083
• Lead Sponsor: VA Eastern Colorado Health Care System

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-09-19
• Study Start: 2024-03-20
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 472

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Eastern Colorado Health Care System; 🇺🇸 Aurora, Colorado, United States