Clinical trial NCT06375083: Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression
Official title: Implementing Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression Among At-Risk Rural and Urban Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Suicide
Depression
Keywords: Suicide
Depression
Veterans
Cognitive Behavioral Therapy
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
First posted: 2024-04-19
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cognitive Behavioral Therapy for Suicide Prevention (cCBT-SP) and Cognitive Behavioral Therapy for Depression (cCBT-D)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: 12 weeks
measure: Internet Evaluation and Utility Questionnaire
timeFrame: 12 weeks
measure: Internet Impact and Effectiveness Questionnaire
timeFrame: 12 weeks
measure: Narrative Evaluation of Intervention Interview
timeFrame: 12 weeks
measure: Recruitment Rate
timeFrame: 12 weeks
measure: Completion of intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Beck Scale for Suicide Ideation
timeFrame: 12 weeks
measure: Patient Health Questionnaire-9
timeFrame: 12 weeks
measure: Posttraumatic Stress Disorder Checklist-5
timeFrame: 12 weeks
measure: Generalized Anxiety Disorder-7
timeFrame: 12 weeks
measure: Computerized Adaptive Testing - Suicide Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Eastern Colorado Health Care System
state: Colorado
Study officials:
affiliation: VA Eastern Colorado Health Care System
name: Lisa A Brenner, PhD
role: PRINCIPAL_INVESTIGATOR
References: