Telepsychology-Service Delivery for Depressed Elderly Veterans

NCT ID: NCT00324701

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2012-10-31

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.

Conditions

Depression; Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telepsychology

therapy done at patients house

Group Type: EXPERIMENTAL

Telepsychology

Intervention Type: BEHAVIORAL

therapy done at patients house

Face-to-face therapy

therapy delivered at the VAMC

Group Type: ACTIVE_COMPARATOR

Face-to-face therapy

Intervention Type: BEHAVIORAL

therapy delivered at the VAMC

Interventions

Telepsychology

therapy done at patients house

Intervention Type: BEHAVIORAL

Face-to-face therapy

therapy delivered at the VAMC

Intervention Type: BEHAVIORAL

Eligibility 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).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

University of Maryland

OTHER

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonard E. Egede, MD MS

Role: PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center, Charleston, SC

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States

Countries

United States

References

Cluver JS, Schuyler D, Frueh BC, Brescia F, Arana GW. Remote psychotherapy for terminally ill cancer patients. J Telemed Telecare. 2005;11(3):157-9. doi: 10.1258/1357633053688741.

Reference Type: BACKGROUND

PMID: 15901444 (View on PubMed)

Egede LE, Frueh CB, Richardson LK, Acierno R, Mauldin PD, Knapp RG, Lejuez C. Rationale and design: telepsychology service delivery for depressed elderly veterans. Trials. 2009 Apr 20;10:22. doi: 10.1186/1745-6215-10-22.

Reference Type: RESULT

PMID: 19379517 (View on PubMed)

Richardson LK, Frueh BC, Grubaugh AL, Egede L, Elhai JD. Current Directions in Videoconferencing Tele-Mental Health Research. Clin Psychol (New York). 2009 Sep 1;16(3):323-338. doi: 10.1111/j.1468-2850.2009.01170.x.

Reference Type: RESULT

PMID: 20161010 (View on PubMed)

Osborn CY, Egede LE. The relationship between depressive symptoms and medication nonadherence in type 2 diabetes: the role of social support. Gen Hosp Psychiatry. 2012 May-Jun;34(3):249-53. doi: 10.1016/j.genhosppsych.2012.01.015. Epub 2012 Mar 7.

Reference Type: RESULT

PMID: 22401705 (View on PubMed)

Tuerk PW, Gros DF, Acierno RE, Strachan MK, Egede LE, Morland LA, Greene CJ, Myrick DL, Frueh BC. Delivery of evidence-based psychotherapy via video telehealth. Journal of psychopathology and behavioral assessment. 2013 Dec 1; 35(4):506-521.

Reference Type: RESULT

Egede LE, Dismuke CE, Walker RJ, Acierno R, Frueh BC. Cost-Effectiveness of Behavioral Activation for Depression in Older Adult Veterans: In-Person Care Versus Telehealth. J Clin Psychiatry. 2018 Aug 28;79(5):17m11888. doi: 10.4088/JCP.17m11888.

Reference Type: DERIVED

PMID: 30192446 (View on PubMed)

Egede LE, Acierno R, Knapp RG, Walker RJ, Payne EH, Frueh BC. Psychotherapy for Depression in Older Veterans Via Telemedicine: Effect on Quality of Life, Satisfaction, Treatment Credibility, and Service Delivery Perception. J Clin Psychiatry. 2016 Dec;77(12):1704-1711. doi: 10.4088/JCP.16m10951.

Reference Type: DERIVED

PMID: 27835713 (View on PubMed)

Egede LE, Acierno R, Knapp RG, Lejuez C, Hernandez-Tejada M, Payne EH, Frueh BC. Psychotherapy for depression in older veterans via telemedicine: a randomised, open-label, non-inferiority trial. Lancet Psychiatry. 2015 Aug;2(8):693-701. doi: 10.1016/S2215-0366(15)00122-4. Epub 2015 Jul 16.

Reference Type: DERIVED

PMID: 26249300 (View on PubMed)

Other Identifiers

HR16402

Identifier Type: OTHER

Identifier Source: secondary_id

IIR 04-421

Identifier Type: -

Identifier Source: org_study_id