Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00105690
Other study ID # IIR 00-078
Secondary ID
Status Completed
Phase N/A
First received March 16, 2005
Last updated April 6, 2015
Start date April 2003
Est. completion date October 2004

Study information

Verified date September 2006
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

We adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by primary care providers in small rural practices and evaluated the effectiveness and cost-effectiveness of telemedicine-based collaborative care.


Description:

BACKGROUND / RATIONALE: Implementing collaborative care for depression in small rural Primary Care (PC) practices without on-site mental health specialists presents unique challenges. We adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by PC providers in small rural practices. The Telemedicine Enhanced Antidepressant Management (TEAM) collaborative care intervention was implemented by offsite personnel and all intervention components were implemented using telemedicine technologies. OBJECTIVE(S): Specific Aim 1: Determine whether the TEAM intervention improves quality and outcomes compared to usual care. Specific Aim 2: Determine whether the TEAM intervention will be cost-effective in routine practice settings. METHODS: Seven VISN 16 CBOCs participated in the study. CBOCs were included if they 1) treated >1,000 and <5,000 unique veterans, 2) had no on-site psychiatrists, and 3) had interactive video equipment. Matched CBOCs were randomized to receive the intervention or usual care. Of the 24,882 clinic patients, 73.6% (n=18,306) were successfully screened and 6.9% screened positive for depression (PHQ9 =12). Of those eligible for the study, 91.3% agreed to participate, and 91.9% of those attended their appointment and were consented. Over an 18-month period, 395 patients were enrolled, and 91.1% (n=360) were followed-up at six months. Telephone research interviews were conducted at baseline, six and twelve months. Effectiveness was tested using an intent-to-treat analysis. Cost-effectiveness analysis was assessed from the perspective of the VA. Costs included intervention costs, encounter costs, and medication costs. Quality Adjusted Life Years (QALYs) were calculated using the Quality of Well Being Scale.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date October 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

PHQ9 Score > or = to 12

Exclusion Criteria:

A diagnosis of schizophrenia, current suicide ideation, recent bereavement, or receiving specialty mental health treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Telemedicine intervention


Locations

Country Name City State
United States G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS Jackson Mississippi
United States Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR No. Little Rock Arkansas
United States Overton Brooks VA Medical Center, Shreveport, LA Shreveport Louisiana

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (12)

Davis TD, Deen T, Bryant-Bedell K, Tate V, Fortney J. Does minority racial-ethnic status moderate outcomes of collaborative care for depression? Psychiatr Serv. 2011 Nov;62(11):1282-8. doi: 10.1176/appi.ps.62.11.1282. — View Citation

Deen TL, Fortney JC, Pyne JM. Relationship between satisfaction, patient-centered care, adherence and outcomes among patients in a collaborative care trial for depression. Adm Policy Ment Health. 2011 Sep;38(5):345-55. doi: 10.1007/s10488-010-0322-z. — View Citation

Edlund MJ, Fortney JC, Reaves CM, Pyne JM, Mittal D. Beliefs about depression and depression treatment among depressed veterans. Med Care. 2008 Jun;46(6):581-9. doi: 10.1097/MLR.0b013e3181648e46. — View Citation

Fortney JC, Enderle MA, Clothier JL, Otero JM, Williams JS, Pyne JM. Population level effectiveness of implementing collaborative care management for depression. Gen Hosp Psychiatry. 2013 Sep-Oct;35(5):455-60. doi: 10.1016/j.genhosppsych.2013.04.010. Epub — View Citation

Fortney JC, Maciejewski ML, Tripathi SP, Deen TL, Pyne JM. A budget impact analysis of telemedicine-based collaborative care for depression. Med Care. 2011 Sep;49(9):872-80. doi: 10.1097/MLR.0b013e31821d2b35. — View Citation

Fortney JC, Pyne JM, Edlund MJ, Mittal D. Relationship between antidepressant medication possession and treatment response. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):377-9. doi: 10.1016/j.genhosppsych.2010.03.008. Epub 2010 May 4. — View Citation

Fortney JC, Pyne JM, Edlund MJ, Robinson DE, Mittal D, Henderson KL. Design and implementation of the telemedicine-enhanced antidepressant management study. Gen Hosp Psychiatry. 2006 Jan-Feb;28(1):18-26. — View Citation

Fortney JC, Pyne JM, Edlund MJ, Stecker T, Mittal D, Robinson DE, Henderson KL. Reasons for antidepressant nonadherence among veterans treated in primary care clinics. J Clin Psychiatry. 2011 Jun;72(6):827-34. doi: 10.4088/JCP.09m05528blu. Epub 2010 Nov 1 — View Citation

Fortney JC, Pyne JM, Steven CA, Williams JS, Hedrick RG, Lunsford AK, Raney WN, Ackerman BA, Ducker LO, Bonner LM, Smith JL. A Web-based clinical decision support system for depression care management. Am J Manag Care. 2010 Nov;16(11):849-54. — View Citation

Mittal D, Fortney JC, Pyne JM, Edlund MJ, Wetherell JL. Impact of comorbid anxiety disorders on health-related quality of life among patients with major depressive disorder. Psychiatr Serv. 2006 Dec;57(12):1731-7. — View Citation

Mittal D, Fortney JC, Pyne JM, Wetherell JL. Predictors of persistence of comorbid generalized anxiety disorder among veterans with major depressive disorder. J Clin Psychiatry. 2011 Nov;72(11):1445-51. doi: 10.4088/JCP.10m05981blu. Epub 2010 Dec 14. — View Citation

Pyne JM, Fortney JC, Tripathi SP, Maciejewski ML, Edlund MJ, Williams DK. Cost-effectiveness analysis of a rural telemedicine collaborative care intervention for depression. Arch Gen Psychiatry. 2010 Aug;67(8):812-21. doi: 10.1001/archgenpsychiatry.2010.8 — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 1) Antidepressant prescribing, 2) Medication adherence, 3) Treatment response and remission, 4) Health status and health related quality of life No
Secondary 1) Satisfaction with care, 2) service utilization, 3) Cost, 4) Cost-effectiveness No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A