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Telepsychology-Service Delivery for Depressed Elderly Veterans
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, October 2008
Sponsors and Collaborators: Department of Veterans Affairs
Medical University of South Carolina
University of Maryland
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00324701
  Purpose

The purpose of this study is to see whether therapy for elderly adults with major depression can be delivered effectively using videoconferencing technology ("telepsychology"), which allows a therapist and patient who are not in the same room as one another to communicate. We are interested in learning if this form of mental health service delivery is an acceptable alternative to traditional face-to-face therapy delivered with the therapist in the same room as the patient.


Condition Intervention
Depression
Aged
Behavioral: Telepsychology
Behavioral: Face-to-face therapy

MedlinePlus related topics: Depression Mental Health
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Telepsychology-Service Delivery for Depressed Elderly Veterans

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Is in-home telepsychology for major depressive disorder in older adults as effective as same-room treatment on clinical and process outcomes? Is in-home telepsychology for major depressive disorder in older adults cost-effective? [ Time Frame: Outcome measured assessed at post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The ultimate objective is to obtain information on whether telepsychology is an acceptable and effective alternative to traditional face-to-face mental health treatment for elderly veterans living in rural areas, many of whom are minorities. [ Time Frame: Outcome measured assessed at post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 224
Study Start Date: September 2006
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Behavioral: Telepsychology
therapy done at patients house
Behavioral: Face-to-face therapy
therapy delivered at the VAMC

Detailed Description:

ABSTRACT

Telepsychology: Service Delivery for Depressed Elderly Veterans

  1. 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.
  2. 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.
  3. 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.
  4. Findings: None yet.
  5. Clinical Relationship: Findings will allow for improved service delivery and access to elderly depressed veterans.
  6. 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.
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will be older male and female veterans,
  • age 60 and above,
  • with diagnoses of major depressive disorder (MDD) assigned on the basis of the Structured Clinical Interview for DSM-IV (SCID; Spitzer et al., 1997).

Exclusion Criteria:

  • Actively psychotic or demented persons,
  • individuals with both suicidal ideation and clear intent, and
  • individuals meeting criteria for substance dependence will be excluded from participation.

However, in order to maximize generalization of results, presence of other forms of psychopathology will not be a basis for exclusion. All of these structured interviews will be audiotaped in order to calculate inter-rater reliability on a randomly selected 20%. (See Human Subjects for procedures in place for suicidal participants or potential participants).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324701

Contacts
Contact: Sarah A Jackson, BA MA (843) 789-7587 sarah.jackson@va.gov
Contact: Aaron D Victor, AAS BAS (843) 789-6624 aaron.victor@va.gov

Locations
United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston Recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Leonard E Egede, MD MS     (843) 789-6670     egedel@musc.edu    
Contact: Sarah A Jackson, BA MA     (843) 789-7587     sarah.jackson@va.gov    
Principal Investigator: Leonard E. Egede, MD MS            
Sub-Investigator: Bartley Christopher Frueh, PhD            
Sub-Investigator: Patrick D Mauldin, BS MA PhD            
Sub-Investigator: Rebecca Grant Knapp, BS MS PhD            
Sub-Investigator: Ronald E. Acierno, BA MS PhD            
Sponsors and Collaborators
Medical University of South Carolina
University of Maryland
Investigators
Principal Investigator: Leonard E. Egede, MD MS Ralph H Johnson VA Medical Center, Charleston
  More Information

Responsible Party: Department of Veterans Affairs ( Egede, Leonard - Principal Investigator )
Study ID Numbers: IIR 04-421, HR16402
Study First Received: May 9, 2006
Last Updated: October 8, 2008
ClinicalTrials.gov Identifier: NCT00324701  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Mental Health
Geriatric Medicine
Depression
Health Service Delivery
Aged

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009