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Clinical Trials/NCT07547709
NCT07547709
Not yet recruiting
Phase 2

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

VA Eastern Colorado Health Care System0 sites20 target enrollmentStarted: June 1, 2026Last updated:
ConditionsDepression

Overview

Phase
Phase 2
Status
Not yet recruiting
Enrollment
20
Primary Endpoint
Client Satisfaction Questionnaire (CSQ)

Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Individual aged between 18 and 65
  • 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.
  • 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

  • 1\. 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 precluding the ability to provide informed consent

Arms & Interventions

cCBT-D for Caregivers Online Intervention

Experimental

Intervention: cCBT-D for Caregivers (Behavioral)

Outcomes

Primary Outcomes

Client Satisfaction Questionnaire (CSQ)

Time Frame: Post-Intervention - After participation in online intervention - up to 14 weeks after consent

Satisfaction with the intervention

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

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