NCT06375083

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
472

participants targeted

Target at P75+ for phase_2

Timeline
4mo left

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2024Aug 2026

First Submitted

Initial submission to the registry

September 19, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

September 19, 2023

Last Update Submit

February 17, 2026

Conditions

SuicideDepression

Keywords

SuicideDepressionVeteransCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (5)

  • Beck Scale for Suicide Ideation

    12 weeks

  • Patient Health Questionnaire-9

    12 weeks

  • Posttraumatic Stress Disorder Checklist-5

    12 weeks

  • Generalized Anxiety Disorder-7

    12 weeks

  • Computerized Adaptive Testing - Suicide Scale

    12 weeks

Study Arms (2)

c-CBT for Suicide Prevention

EXPERIMENTAL

CBT for Suicide Prevention

Behavioral: c-CBT for Suicide Prevention

c-CBT for Depression

EXPERIMENTAL

Computerized CBT for Depression

Behavioral: c-CBT or Depression

Interventions

c-CBT for Suicide PreventionBEHAVIORAL

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 for Suicide Prevention
c-CBT or DepressionBEHAVIORAL

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.

c-CBT for Depression

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Veterans between the ages of 18 and 65
  • 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
  • PHQ-9 score below 4 or 15 and above
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Colorado Health Care System

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

SuicideDepression

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Lisa A Brenner, PhD

    VA Eastern Colorado Health Care System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly A Stearns-Yoder, MA

CONTACT

720-723-6477kelly.stearns@va.gov

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cognitive Behavioral Therapy for Suicide Prevention (cCBT-SP) or Cognitive Behavioral Therapy for Depression (cCBT-D)
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2023

First Posted

April 19, 2024

Study Start

March 20, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)