NCT07547709

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2 depression

Timeline
5mo left

Started Jun 2026

Shorter than P25 for phase_2 depression

Status
not yet 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

First Submitted

Initial submission to the registry

April 6, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 6, 2026

Last Update Submit

April 16, 2026

Conditions

Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

  • Client Satisfaction Questionnaire (CSQ)

    Satisfaction with the intervention

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

Study Arms (1)

cCBT-D for Caregivers Online Intervention

EXPERIMENTAL
Behavioral: cCBT-D for Caregivers

Interventions

cCBT-D for CaregiversBEHAVIORAL

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

cCBT-D for Caregivers Online Intervention

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Ryan Holliday

    US Department of Veterans Affairs

    PRINCIPAL INVESTIGATOR

  • Lisa Brenner, Ph.D.

    US Department of Veterans Affairs

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Brenner, Ph.D.

CONTACT

720-315-6454lisa.brenner@va.gov

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 23, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

VA Policy