Telepsychology-Service Delivery for Depressed Elderly Veterans

This study has been completed.
Sponsor:
Collaborators:
Medical University of South Carolina
University of Maryland
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00324701
First received: May 9, 2006
Last updated: April 15, 2014
Last verified: April 2014
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telepsychology-Service Delivery for Depressed Elderly Veterans

Resource links provided by NLM:


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:
  • Beck Anxiety Inventory [ Time Frame: pre-treatment, 4week, 8 week & Post treatment (3mos & 12 mos) ] [ Designated as safety issue: No ]
    The BAI is a 21 item self report rating scale that measures anxiety

  • Beck Depression Inventory [ Time Frame: pre-treatment, 4week, 8 week & Post treatment (3mos & 12 mos) ] [ Designated as safety issue: No ]
    The BDI is a 21 item self report scale that measure depression

  • Geriatric Depression Scale [ Time Frame: pre-treatment, 4week, 8 week & Post treatment (3mos & 12 mos) ] [ Designated as safety issue: No ]
    The Geriatric Depression Scale (GDS) is a 30-item self-report assessment designed specifically to identify depression in the elderly

  • SF-36 [ Time Frame: pre-treatment, 4week, 8 week & Post treatment (3mos & 12 mos) ] [ Designated as safety issue: No ]
    The SF 36 is a 36 item questionnaire that measure health status and functioning over the past 4 weeks

  • Charleston Psychiatric Outpatient Satisfaction Scale [ Time Frame: post treatment ] [ Designated as safety issue: No ]
    CPOSS-VA is a 16 item measure based on general measure of patient satisfaction

  • Treatment Credibility [ Time Frame: post treatment ] [ Designated as safety issue: No ]
    to assess for differences in outcome expectancy and treatment expectancy. Four questions will be asked regarding how logical the treatment seems, how confident participants are about treatment, and their expectancy for success

  • Service Delivery Perceptions Questionnaire [ Time Frame: post treatment ] [ Designated as safety issue: No ]
    The questionnaire will be used to assess subjects' perceptions about variables specifically related to the mode of service delivery (e.g. the quality of communication, ease of use, willingness to use treatment)

  • Prior Experience with Computer and Audiovisual Technology [ Time Frame: post treatment ] [ Designated as safety issue: No ]
    measure about subjects prior experiences and comfort level with computers and audiovisual technology

  • SCID: Structured Clinical Interview for the DSM-IV [ Time Frame: pre-treatment and post treatment ] [ Designated as safety issue: No ]
    Depression, PTSD, Panic, GAD will be evaluated using the DSM-IV.


Estimated Enrollment: 224
Study Start Date: September 2006
Study Completion Date: October 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 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: Analysis of data is currently in process.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, South Carolina
Ralph H Johhnson VA Medical Center
Charleston, South Carolina, United States, 29401-5799
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

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00324701     History of Changes
Other Study ID Numbers: IIR 04-421, HR16402
Study First Received: May 9, 2006
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014