Phase 2
N=85
Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas
Depressive Disorder · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00223652 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Change in Severity of Depression Using Hamilton Depression Rating Scale — 20.83; 19.23; 16.71; 17.27 units on a scale — p==.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Telephone cognitive behavioral therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Severity of Depression Using Hamilton Depression Rating Scale |
20.83; 19.23; 16.71; 17.27; 15.43; 17.00 | =.001 sig |
| PRIMARY Change in Severity of Depression Using the Patient Health Questionnaire-9 |
17.12; 17.39; 12.19; 14.35; 11.15; 12.90 | <.0001 sig |
| PRIMARY Number of Participants Meeting Criteria for Major Depressive Disorder |
41; 44; 20; 29; 19; 23 | <0.0001 sig |
| SECONDARY Maintenance of Treatment Effect |
11.25; 12.26 | >0.37 |
| SECONDARY Maintenance of Treatment Effect |
11.25; 12.26 | >0.37 |
| SECONDARY Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up |
16; 18 | >0.37 |
Summary
The purpose of this study is to examine the efficacy of telephone-administered cognitive-behavioral therapy (T-CBT) in treating major depression among veterans served by community-based outpatient clinics (CBOCs) in the Veteran's Integrated Service Network (VISN) 21, which serves rural areas in Northern California and (VISN) 12, which serves rural areas surrounding the Hines, IL VA Hospital.
Eligibility Criteria
Inclusion Criteria
- Has a DSM-IV diagnosis of Major Depressive Disorder as assessed using the MINI
- Has a telephone
- Able to speak and read English
- At least 18 years of age
- Able to give informed consent
- Must be registered at a VA community-based, outpatient clinic (CBOC) at VA Eureka or VA Ukiah or VA Santa Rosa, or VA Manteno, or VA Elgin, or VA La Salle
Exclusion Criteria
- Has a hearing, voice or visual impairment that would prevent participation in T-CBT
- Meets criteria for dementia
- Is diagnosed with Psychotic Disorder, Bipolar Disorder, substance abuse with clinical consensus, or current severe PTSD.
- Is currently receiving psychotherapy or planning to receive psychotherapy during the 20-week treatment phase of the study
- Has a history of suicide attempts or is at high risk for suicide.
Data sourced from ClinicalTrials.gov (NCT00223652). 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.