Telepsychology-Service Delivery for Depressed Elderly Veterans
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|ClinicalTrials.gov Identifier: NCT00324701|
Recruitment Status : Completed
First Posted : May 11, 2006
Results First Posted : November 26, 2014
Last Update Posted : April 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Depression Elderly||Behavioral: Telepsychology Behavioral: Face-to-face therapy||Not Applicable|
Telepsychology: Service Delivery for Depressed Elderly Veterans
- Objective: The immediate objective is to test the hypothesis that a novel mode of geriatric mental health service delivery, using in-home videoconferencing technology ("Telepsychology"), will be as effective as the traditional mode of service delivery ("Same-Room") for treating older adult veterans suffering from major depressive disorder (MDD). The ultimate objective is to help the VA develop and evaluate strategies for providing mental health care to elderly veterans who live in rural areas, many of whom are minorities.
- Research Design: This project is a 4-year prospective, randomized between-groups study comparing the efficacy of an intervention for geriatric depression delivered via two different modes (Telepsychology, Same-Room). Participants in the Telepsychology condition will receive care in their own home via videophone contact with a therapist at the Charleston VA Medical Center; participants in the Same-room condition will receive their care via traditional face-to-face therapy sessions held at the Charleston VA Medical Center. Two-hundred twenty-four (224) participants will be recruited from primary care and mental health clinics within the Charleston VA Medical Center catchment area. Treatment will be administered over an 8-week period (active treatment phase); and participants will be followed for an additional 12-months (follow-up phase) to ascertain longer-term effects of treatment on three outcome domains: (1) clinical outcomes: symptom severity and social functioning; (2) process outcomes: patient satisfaction and acceptance, treatment credibility, session attendance, treatment adherence, and treatment dropout; and (3) cost-effectiveness.
- Methodology: Population and Sample: Participants will be elderly veterans (N = 224), age 60 and above, with diagnoses of major depressive disorder (MDD). Based on our previous research and local demographics, we expect approximately 40% of our sample will be African-American. Types of Data: To assess outcome, we will use measures that have been widely validated in the clinical evaluation of older adults with MDD. Measures will be collected at pre-treatment, post-treatment, 3-, and 12-month follow-up. Data Analyses Plan: The primary clinical response variable is proportion (%) of patients who respond to treatment, where treatment response is defined as at least a 50% improvement from baseline to post-treatment level on the GDS (percent change from baseline:[baseline-post]/baseline >= 50%). Two approaches to estimation of the primary response variable will be taken. The first approach will estimate proportion of responders (% responders) at the end of the 8-week active treatment course based on the total number randomized to each treatment. This is equivalent to a "worst case" analysis in which all premature exits (for whom response status is missing) will be treated as non-responders. We will also estimate proportion of responders for each treatment based on only those who complete the 8-week treatment course (completer analysis). The second approach will use multivariable logistic regression to estimate adjusted % responders. Finally, we will conduct a range of analyses between African-American and Caucasian subjects to look at differential efficacy, patient preferences and satisfaction, and adherence across racial groups.
- Findings: Analysis of data is currently in process.
- Clinical Relationship: Findings will allow for improved service delivery and access to elderly depressed veterans.
- Impact/Significance: The telepsychology literature is undeveloped. The VA has made telehealth a priority strategy for bringing quality services to veterans in rural areas. Therefore, research that addresses the efficacy of this mode of service delivery is acutely needed. If Telepsychology efficacy and cost-effectiveness is demonstrated, then future research and program development will bring specialized mental health services to the homes of minority veterans or VA community based outpatient clinics. Further, if Telepsychology effectiveness can be empirically established, then we can proceed with research that examines a range of important system issues. Thus, this project represents a step in a major programmatic line of research in mental health service delivery to rural and underserved populations.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||241 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Telepsychology-Service Delivery for Depressed Elderly Veterans|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||October 2012|
therapy done at patients house
therapy done at patients house
Active Comparator: Face-to-face therapy
therapy delivered at the VAMC
Behavioral: Face-to-face therapy
therapy delivered at the VAMC
- At Least a 50% Improvement From Baseline to Post-treatment on the Geriatric Depression Scale (GDS) [ Time Frame: 8 week & 12 months ]The Geriatric Depression Scale (GDS) is a 30-item self-report assessment designed specifically to identify depression in the elderly. Participants are asked to respond by answering yes or no in reference to how they felt over the past week. Higher scores indicate more severe depression.
- SCID: Structured Clinical Interview for the DSM-IV [ Time Frame: 12 months ]Structured clinical interview for the DSM-IV (SCID) administered by raters blind to subject condition. Structured interviews included psychiatric assessment for depression, PTSD, panic, generalized anxiety disorder (GAD) evaluated using the DSM-IV.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324701
|United States, South Carolina|
|Ralph H. Johnson VA Medical Center, Charleston, SC|
|Charleston, South Carolina, United States, 29401-5799|
|Principal Investigator:||Leonard E. Egede, MD MS||Ralph H. Johnson VA Medical Center, Charleston, SC|