NCT00324701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 26, 2014

Completed
Last Updated

April 24, 2015

Status Verified

September 1, 2014

Enrollment Period

4.8 years

First QC Date

May 9, 2006

Results QC Date

November 6, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

Mental HealthGeriatric MedicineDepressionHealth Service DeliveryAged

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 week & 12 months

Secondary Outcomes (1)

  • SCID: Structured Clinical Interview for the DSM-IV

    12 months

Study Arms (2)

Telepsychology

EXPERIMENTAL

therapy done at patients house

Behavioral: Telepsychology

Face-to-face therapy

ACTIVE COMPARATOR

therapy delivered at the VAMC

Behavioral: Face-to-face therapy

Interventions

TelepsychologyBEHAVIORAL

therapy done at patients house

Telepsychology

therapy delivered at the VAMC

Face-to-face therapy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related Publications (8)

  • 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.

    PMID: 15901444BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

    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.

  • 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.

  • 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.

MeSH Terms

Conditions

DepressionPsychological Well-Being

Interventions

Mental Health Teletherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Results Point of Contact

Title
Leonard E. Egede, MD, MS
Organization
Ralph H. Johnson VAMC

Study Officials

  • Leonard E. Egede, MD MS

    Ralph H. Johnson VA Medical Center, Charleston, SC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 11, 2006

Study Start

September 1, 2006

Primary Completion

July 1, 2011

Study Completion

October 1, 2012

Last Updated

April 24, 2015

Results First Posted

November 26, 2014

Record last verified: 2014-09

Locations