Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06375083
• Other study ID #: 23-1231
• Status: Recruiting
• Phase: Phase 2
• Start date: March 20, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: VA Eastern Colorado Health Care System
• Contact: Kelly A Stearns-Yoder, MA
• Phone: 720-723-6477
• Email: kelly.stearns[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 472
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Suicide
• Suicide Prevention

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Eastern Colorado Health Care System	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Eastern Colorado Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Client Satisfaction Questionnaire	Acceptability	12 weeks
Primary	Internet Evaluation and Utility Questionnaire	Acceptability	12 weeks
Primary	Internet Impact and Effectiveness Questionnaire	Acceptability	12 weeks
Primary	Narrative Evaluation of Intervention Interview	Acceptability	12 weeks
Primary	Recruitment Rate	Feasibility (Data regarding participant recruitment rates will be collected.)	12 weeks
Primary	Completion of intervention	Feasibility (Data regarding completion of intervention and completion of study procedures will be collected.)	12 weeks
Secondary	Beck Scale for Suicide Ideation	Change in suicidal ideation	12 weeks
Secondary	Patient Health Questionnaire-9	Change in depression symptoms	12 weeks
Secondary	Posttraumatic Stress Disorder Checklist-5	Change in PTSD symptoms	12 weeks
Secondary	Generalized Anxiety Disorder-7	Change in anxiety symptoms	12 weeks
Secondary	Computerized Adaptive Testing - Suicide Scale	Change in suicidal ideation	12 weeks