SuicidePhase 2NCT06375083
Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression
A Phase 2 study testing c-CBT for Suicide Prevention and c-CBT or Depression in people with Suicide and Depression, run by VA Eastern Colorado Health Care System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide, Depression
- What is being tested?
- c-CBT for Suicide Prevention and c-CBT or Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2024to 30 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans between the ages of 18 and 65
- Currently living in Colorado, New York, Montana, Texas, or Utah who have accessed VA Care
- 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)
- Reliable access to a computer/tablet and the internet
- Ability to provide informed consent
- Veterans between the ages of 18 and 65
Show all 10Show fewer
- Currently living in Colorado, New York, Montana, Texas, or Utah who have accessed VA care
- Mild to moderate depressive symptoms, as determined by the PHQ-9, (score of 5-14)
- Reliable access to a computer/tablet and the internet
- Ability to provide informed consent
Who cannot join
- Active alcohol or substance use disorder, excluding Cannabis dependence, as determined by screening or electronic medical record
- Identification of active psychosis or bipolar disorder, as determined via screening or electronic medical record
- Severe cognitive impairment, as determined by screening or electronic medical record
- Currently enrolled in/participating in another mental health-related intervention research study
- Cohort B - cCBT-D Program
- PHQ-9 score below 4 or 15 and above
Show all 10Show fewer
- Active alcohol or substance use disorder, excluding Cannabis dependence, as determined by screening or electronic medical record
- Identification of active psychosis or bipolar disorder, as determined via screening or electronic medical record
- Severe cognitive impairment, as determined by screening or electronic medical record
- Currently enrolled in/participating in other intervention research study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Eastern Colorado Health Care System
Aurora, Colorado, 80045
Lisa A Brenner, PhD, 720-723-6488, Lisa.Brenner@va.gov
Kelly A Stearns-Yoder, MA, 720-723-6477, Kelly.Stearns@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide, Depression
- Being tested
- c-CBT for Suicide Prevention, c-CBT or Depression
- Keywords
- Suicide, Depression, Veterans, Cognitive Behavioral Therapy
- Medical subject headings
- Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
c-CBT for Suicide PreventionBehavioural
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.
c-CBT or DepressionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| c-CBT for Suicide Prevention | Experimental | CBT for Suicide Prevention Receives: Behavioral: c-CBT for Suicide Prevention |
| c-CBT for Depression | Experimental | Computerized CBT for Depression Receives: Behavioral: c-CBT or Depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire
Acceptability
Measured: 12 weeks
Internet Evaluation and Utility Questionnaire
Acceptability
Measured: 12 weeks
Internet Impact and Effectiveness Questionnaire
Acceptability
Measured: 12 weeks
Narrative Evaluation of Intervention Interview
Acceptability
Measured: 12 weeks
Recruitment Rate
Number of individuals who consented to participate
Measured: 12 weeks
Completion of intervention
Number of participants who completed most or all of the sessions
Measured: 12 weeks
Secondary outcomes (5)
Beck Scale for Suicide Ideation
Change in suicidal ideation
Measured: 12 weeks
Patient Health Questionnaire-9
Change in depression symptoms
Measured: 12 weeks
Posttraumatic Stress Disorder Checklist-5
Change in PTSD symptoms
Measured: 12 weeks
Generalized Anxiety Disorder-7
Change in anxiety symptoms
Measured: 12 weeks
Computerized Adaptive Testing - Suicide Scale
Change in suicidal ideation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start20 Mar 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cognitive Behavioral Therapy for Suicide Prevention (cCBT-SP) or Cognitive Behavioral Therapy for Depression (cCBT-D)
- Masking
- None (open label)
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisa A Brenner, PhD, Principal investigator, VA Eastern Colorado Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375083
- Sponsor's protocol ID
- 23-1231
- Status last verified
- Feb 2026
- First submitted
- 19 Sep 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression Among At-Risk Rural and Urban Veterans
- ClinicalTrials.gov ID
- NCT06375083
- Acronym / sponsor ID
- 23-1231
- Conditions
- Suicide, Depression
- Keywords
- Suicide, Depression, Veterans, Cognitive Behavioral Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cognitive Behavioral Therapy for Suicide Prevention (cCBT-SP) or Cognitive Behavioral Therapy for Depression (cCBT-D)
| Arm | Type | Receives |
|---|---|---|
| c-CBT for Suicide Prevention | Experimental | Behavioral: c-CBT for Suicide PreventionCBT for Suicide Prevention |
| c-CBT for Depression | Experimental | Behavioral: c-CBT or DepressionComputerized CBT for Depression |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Veterans between the ages of 18 and 65
- Currently living in Colorado, New York, Montana, Texas, or Utah who have accessed VA Care
- 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)
- Reliable access to a computer/tablet and the internet
- Ability to provide informed consent
Key exclusion criteria (10 listed)
- Active alcohol or substance use disorder, excluding Cannabis dependence, as determined by screening or electronic medical record
- Identification of active psychosis or bipolar disorder, as determined via screening or electronic medical record
- Severe cognitive impairment, as determined by screening or electronic medical record
- Currently enrolled in/participating in another mental health-related intervention research study
- Cohort B - cCBT-D Program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| c-CBT for Suicide PreventionOnline 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. | Behavioural | c-CBT for Suicide Prevention |
| c-CBT or DepressionThe computerized Cognitive Behavioral Therapy for Depression (cCBT-D) course is comprised of 12 online sessions and is augmented by use of a companion workbook. | Behavioural | c-CBT for Depression |
Primary outcome
Client Satisfaction Questionnaire
Time frame: 12 weeks
Acceptability
Internet Evaluation and Utility Questionnaire
Time frame: 12 weeks
Acceptability
Internet Impact and Effectiveness Questionnaire
Time frame: 12 weeks
Acceptability
Narrative Evaluation of Intervention Interview
Time frame: 12 weeks
Acceptability
Recruitment Rate
Time frame: 12 weeks
Number of individuals who consented to participate
Completion of intervention
Time frame: 12 weeks
Number of participants who completed most or all of the sessions
5 secondary outcomes
Beck Scale for Suicide Ideation
Time frame: 12 weeks
Patient Health Questionnaire-9
Time frame: 12 weeks
Posttraumatic Stress Disorder Checklist-5
Time frame: 12 weeks
Generalized Anxiety Disorder-7
Time frame: 12 weeks
Computerized Adaptive Testing - Suicide Scale
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Suicide
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Recruiting
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
Suicide, Bereavement
Not yet recruiting
Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
Suicide, Mental Health Stigma
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa A Brenner, PhD principal investigator
VA Eastern Colorado Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing c-CBT for Suicide Prevention and c-CBT or Depression in people with Suicide and Depression, run by VA Eastern Colorado Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly A Stearns-Yoder, MA (720-723-6477, kelly.stearns@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.