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Telepsychology-Service Delivery for Depressed Elderly Veterans

Telepsychology-Service Delivery for Depressed Elderly Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00324701
Enrollment
241
Registered
2006-05-11
Start date
2006-09-30
Completion date
2012-10-31
Last updated
2015-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Elderly

Keywords

Mental Health, Geriatric Medicine, Depression, Health Service Delivery, Aged

Brief summary

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.

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.

Interventions

BEHAVIORALTelepsychology

therapy done at patients house

therapy delivered at the VAMC

Sponsors

Medical University of South Carolina
CollaboratorOTHER
University of Maryland
CollaboratorOTHER
US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
At Least a 50% Improvement From Baseline to Post-treatment on the Geriatric Depression Scale (GDS)8 week & 12 monthsThe 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.

Secondary

MeasureTime frameDescription
SCID: Structured Clinical Interview for the DSM-IV12 monthsStructured 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Telepsychology
therapy done at patients house using in-home video conferencing technology
120
Face-to-face Therapy
therapy delivered at the VAMC in the same room as the therapist
121
Total241

Baseline characteristics

CharacteristicTotalTelepsychologyFace-to-face Therapy
Age, Continuous63.9 years
STANDARD_DEVIATION 5.1
63.5 years
STANDARD_DEVIATION 4.4
64.2 years
STANDARD_DEVIATION 5.6
Education13.7 years
STANDARD_DEVIATION 2.6
13.5 years
STANDARD_DEVIATION 2.3
13.8 years
STANDARD_DEVIATION 2.9
Income
$0 - < $15,000
49 participants25 participants24 participants
Income
$15,000 - < $25,000
56 participants24 participants32 participants
Income
$25,000 - < $$50,000
93 participants49 participants44 participants
Income
$50,000 or more
40 participants20 participants20 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
94 Participants49 Participants45 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants3 Participants1 Participants
Race (NIH/OMB)
White
143 Participants68 Participants75 Participants
Sex: Female, Male
Female
6 Participants4 Participants2 Participants
Sex: Female, Male
Male
235 Participants116 Participants119 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1200 / 121
serious
Total, serious adverse events
0 / 1200 / 121

Outcome results

Primary

At Least a 50% Improvement From Baseline to Post-treatment on the Geriatric Depression Scale (GDS)

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.

Time frame: 8 week & 12 months

Population: Participants completing 8 week and 12 month assessments.

ArmMeasureGroupValue (NUMBER)
TelepsychologyAt Least a 50% Improvement From Baseline to Post-treatment on the Geriatric Depression Scale (GDS)8 weeks17.6 % participants with treatment response
TelepsychologyAt Least a 50% Improvement From Baseline to Post-treatment on the Geriatric Depression Scale (GDS)12 months22.0 % participants with treatment response
Face-to-face TherapyAt Least a 50% Improvement From Baseline to Post-treatment on the Geriatric Depression Scale (GDS)8 weeks22.4 % participants with treatment response
Face-to-face TherapyAt Least a 50% Improvement From Baseline to Post-treatment on the Geriatric Depression Scale (GDS)12 months20.2 % participants with treatment response
Secondary

SCID: Structured Clinical Interview for the DSM-IV

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.

Time frame: 12 months

Population: Participants completing 12 month assessment

ArmMeasureValue (NUMBER)
TelepsychologySCID: Structured Clinical Interview for the DSM-IV50 % participants with treatment response
Face-to-face TherapySCID: Structured Clinical Interview for the DSM-IV44.2 % participants with treatment response

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026