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Recruiting NCT06375083

Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression

Phase II Interventional Suicide Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: c-CBT for Suicide Prevention, c-CBT or Depression.
Who it may be relevant to
Registry conditions: Suicide, Depression. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral c-CBT for Suicide Prevention
    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.
  • Behavioral c-CBT or Depression
    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.

Primary outcome measures

  • Client Satisfaction Questionnaire [Time frame: 12 weeks]
  • Internet Evaluation and Utility Questionnaire [Time frame: 12 weeks]
  • Internet Impact and Effectiveness Questionnaire [Time frame: 12 weeks]
  • Narrative Evaluation of Intervention Interview [Time frame: 12 weeks]
  • Recruitment Rate [Time frame: 12 weeks]
  • Completion of intervention [Time frame: 12 weeks]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

Cohort A - cCBT-SP Program

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Eastern Colorado Health Care System — Aurora

Identifiers

NCT: NCT06375083 · 23-1231

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗