Computerized Cognitive Behavioral Therapy-Depression (cCBT-D) for Caregivers of Veterans

April 16, 2026 updated by: VA Eastern Colorado Health Care System
Preliminary evaluation a caregiver cCBT-D protocol, including changes in psychosocial functioning and mental health symptoms as well as perceptions of feasibility, acceptability, and safety.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

We will pilot a tailored cCBT-D course (current version is Veteran focused; tailored version currently in development and to be submitted in a future amendment with minor changes to language and examples) is comprised of 12 online sessions. Sessions all have a similar structure that includes: 1) Weekly symptom ratings; 2) Review of practice assignments completed since last session; 3) Presentation of new material; and 4) Practice assignments to be completed in the coming week. Individuals can complete assignments within the course website or by printing out the worksheets. Their course "dashboard," which they see each time they log into the course, allows them to review past and upcoming course activities, read information about skills, and make notes about what was learned.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Individual aged between 18 and 65
  2. Currently serving as a formal (i.e., designated as a legal caretaker [e.g., legally authorized representative of medical care]) or informal (e.g., providing caretaking duties but not formally designated by a legal body) caretaker to a Veteran.
  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 precluding the ability to provide informed consent

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cCBT-D for Caregivers Online Intervention
Behavioral: cCBT-D for Caregivers
The cCBT-D course is compromised of approximately 12 online sessions. Sessions all have a similar structure that includes: 1) Weekly symptom ratings; 2) Review of practice assignments completed since last session; 3) New material; and 4) Practice assignments to be completed in the coming week. Individuals can complete assignments within the course website or by printing out the worksheets. Their course "dashboard," which they see each time they log into the course, allows them to review past and upcoming course activities, read information about skills, and make notes about what was learned. The cCBT-D course uploaded into the initial submission is one developed for Veterans. We are currently in the process of updating this course for Veteran caregivers (e.g., updates to wording for caregivers; including updating examples). We will upload this updated version in a future example (prior to initiating any interventional procedures). Finally, although this project is anticipated to be min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire (CSQ)
Time Frame: Post-Intervention - After participation in online intervention - up to 14 weeks after consent
Satisfaction with the intervention
Post-Intervention - After participation in online intervention - up to 14 weeks after consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Eastern Colorado Health Care System

Collaborators

Denver Research Institute
Face the Fight

Investigators

  • Principal Investigator: Lisa Brenner, Ph.D., US Department of Veterans Affairs
  • Principal Investigator: Ryan Holliday, US Department of Veterans Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-2418
  • 2025060013 (Other Grant/Funding Number: Face the Fight)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

VA Policy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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