N/A
Completed N=330
Veteran Peer-Assisted Computerized Cognitive Behavioral Therapy for Depression
Source: ClinicalTrials.gov NCT02057042 ↗Enrolled (actual)
330
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Functional Status — 32.1; 31.4; 36.2; 37.3 score on a scale — p=<0.05
Summary
The investigators will conduct a randomized clinical trial of Peer-Supported cCBT versus enhanced usual care (EUC) for 330 patients with new episodes of depression in primary care at three VA sites and their associated Community-Based Outpatient Clinics (CBOCs).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Status |
32.1; 31.4; 36.2; 37.3; 37.1; 40.1 | <0.05 sig |
| PRIMARY Depression Symptoms |
13.4; 14.0; 11.7; 11.1; 11.2; 10.6 | <0.05 sig |
| PRIMARY Recovery Orientation |
69.3; 67.1; 71.7; 72.6; 71.1; 74.1 | <0.05 sig |
| PRIMARY Quality of Life Enjoyment and Satisfaction |
38.8; 37.7; 40.5; 41.6; 41.0; 42.5 | <0.05 sig |
| SECONDARY Cognitive Behavioral Therapy Skills |
42.4; 40.4; 45.1; 46.1; 45.9; 48.0 | <0.05 sig |
| SECONDARY Anxiety |
11.3; 11.0; 9.5; 8.8; 9.3; 8.1 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
Patients will be eligible for the study if they:
- have new episodes of depression in primary care, defined as those with a new diagnoses of depression and no prior depression diagnoses or antidepressant fills within 120 days of the index date of their depression diagnosis any of three VA study sites or associated CBOCs. Patients must enroll within 90 days of their diagnosis.
- have a current Patient Health Questionnaire (PHQ)-9 score > 10.
- are not receiving mental health care outside of VHA.
- have broadband internet access at home or confirm willingness, ability, and a plan to go to their VA facility to complete cCBT modules.
- have familiarity with email and internet use.
- have stable access to and ability to communicate by telephone.
Exclusion Criteria
Exclusion criteria for the study will include:
- a diagnosis of schizophrenia, schizoaffective disorder, major depressive disorder (MDD) with psychotic features, or Bipolar I in the past 24 months.
- a positive screen for moderate or severe substance use (AUDIT-C >7).
- an immediate risk of suicide, requiring hospitalization or urgent evaluation (as evidenced by suicidal plan or intent).
- participating in other research studies.
- diagnosis of depression in the past 4 months from a non-VA provider
Data sourced from ClinicalTrials.gov (NCT02057042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.