NCT00012974

Brief Summary

The purpose of this study is to examine the efficacy of telephone-administered cognitive-behavioral therapy (T-CBT) in treating major depression among veterans served by community-based outpatient clinics (CBOCs) in the Veteran�s Integrated Service Network (VISN) 21, which serves rural areas in Northern California

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 heart-failure

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

2 active sites

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

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
4.6 years until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

April 7, 2015

Status Verified

December 1, 2005

First QC Date

March 14, 2001

Last Update Submit

April 6, 2015

Conditions

Heart FailureBeta-blocker Treatment

Outcome Measures

Primary Outcomes (1)

  • Reduction in severity of depression; scores on depression rating scales at baseline, 12 weeks and 24 weeks

Secondary Outcomes (1)

  • Maintenance of treatment gains at 6 month follow-up (week 48).

Study Arms (1)

Arm 1

OTHER
Behavioral: GTelephone-administered Cognitive-Behavioral Therapy (T-CBT)Procedure: Provider education, computer reminders, nurse case management

Interventions

GTelephone-administered Cognitive-Behavioral Therapy (T-CBT)BEHAVIORAL
Arm 1
Provider education, computer reminders, nurse case managementPROCEDURE
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have chronic heart failure, systolic left ventricular dysfunction (ejection fraction less than or equal to 45%), not be receiving beta-blockers, and not have contraindications to beta-blockers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Related Publications (19)

  • Massie BM. Comment--LVADs as long-term cardiac replacement: Success but on what terms and at what cost? J Card Fail. 2002 Apr;8(2):61-2. doi: 10.1054/jcaf.2002.33167. No abstract available.

    PMID: 12016627RESULT

  • Cuffe MS, Califf RM, Adams KF Jr, Benza R, Bourge R, Colucci WS, Massie BM, O'Connor CM, Pina I, Quigg R, Silver MA, Gheorghiade M; Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure (OPTIME-CHF) Investigators. Short-term intravenous milrinone for acute exacerbation of chronic heart failure: a randomized controlled trial. JAMA. 2002 Mar 27;287(12):1541-7. doi: 10.1001/jama.287.12.1541.

    PMID: 11911756RESULT

  • Leier CV, Silver MA, Massie BM, Young JB, Fowler MB, Ventura HO, Hershberger RE. Nuggets, pearls, and vignettes of master heart failure clinicians. Part 1--the medical history. Congest Heart Fail. 2001 Sep-Oct;7(5):245-249. doi: 10.1111/j.1527-5299.2001.00307.x. No abstract available.

    PMID: 11832662RESULT

  • Dauterman KW, Go AS, Rowell R, Gebretsadik T, Gettner S, Massie BM. Congestive heart failure with preserved systolic function in a statewide sample of community hospitals. J Card Fail. 2001 Sep;7(3):221-8. doi: 10.1054/jcaf.2001.26896.

    PMID: 11561221RESULT

  • Go AS, Rao RK, Dauterman KW, Massie BM. A systematic review of the effects of physician specialty on the treatment of coronary disease and heart failure in the United States. Am J Med. 2000 Feb 15;108(3):216-26. doi: 10.1016/s0002-9343(99)00430-1.

    PMID: 10723976RESULT

  • Cuffe MS, Califf RM, Adams KF, Bourge RC, Colucci W, Massie B, O'Connor CM, Pina I, Quigg R, Silver M, Robinson LA, Leimberger JD, Gheorghiade M. Rationale and design of the OPTIME CHF trial: outcomes of a prospective trial of intravenous milrinone for exacerbations of chronic heart failure. Am Heart J. 2000 Jan;139(1 Pt 1):15-22. doi: 10.1016/s0002-8703(00)90303-x.

    PMID: 10618557RESULT

  • Massie BM. Obesity and heart failure--risk factor or mechanism? N Engl J Med. 2002 Aug 1;347(5):358-9. doi: 10.1056/NEJMe020065. No abstract available.

    PMID: 12151474RESULT

  • Massie BM, Armstrong PW, Cleland JG, Horowitz JD, Packer M, Poole-Wilson PA, Ryden L. Toleration of high doses of angiotensin-converting enzyme inhibitors in patients with chronic heart failure: results from the ATLAS trial. The Assessment of Treatment with Lisinopril and Survival. Arch Intern Med. 2001 Jan 22;161(2):165-71. doi: 10.1001/archinte.161.2.165.

    PMID: 11176729RESULT

  • Ashton CM, Bozkurt B, Colucci WB, Kiefe CI, Mann DL, Massie BM, Slawsky MT, Tierney WM, West JA, Whellan DJ, Wray NP. Veterans Affairs Quality Enhancement Research Initiative in chronic heart failure. Med Care. 2000 Jun;38(6 Suppl 1):I26-37. doi: 10.1097/00005650-200006001-00004.

    PMID: 10843268RESULT

  • Gottlieb SS, Abraham W, Butler J, Forman DE, Loh E, Massie BM, O'connor CM, Rich MW, Stevenson LW, Young J, Krumholz HM. The prognostic importance of different definitions of worsening renal function in congestive heart failure. J Card Fail. 2002 Jun;8(3):136-41. doi: 10.1054/jcaf.2002.125289.

    PMID: 12140805RESULT

  • Massie BM. Treating heart failure: it's time for new paradigms and novel approaches. J Card Fail. 2002 Jun;8(3):117-9. doi: 10.1054/jcaf.2002.126485. No abstract available.

    PMID: 12140801RESULT

  • Ansari M, Tutar A, Bullard J, Teerlink J, Massie B. Cardiology specialist care of heart failure patients improves survival. [Abstract]. Journal of the American College of Cardiology. 2001 Jun 1; 37:189A.

    RESULT

  • Massie BM. Neurohormonal blockade in chronic heart failure. How much is enough? Can there be too much? J Am Coll Cardiol. 2002 Jan 2;39(1):79-82. doi: 10.1016/s0735-1097(01)01715-6. No abstract available.

    PMID: 11755290RESULT

  • Ansari M, Tutar A, Bullard J, Teerlink J, Massie B. Heart failure in a veteran cohort: Predictors of outcome. [Abstract]. Journal of the American College of Cardiology. 2001 Jun 1; 37:1581.

    RESULT

  • Frances CD, Noguchi H, Massie BM, Browner WS, McClellan M. Are we inhibited? Renal insufficiency should not preclude the use of ACE inhibitors for patients with myocardial infarction and depressed left ventricular function. Arch Intern Med. 2000 Sep 25;160(17):2645-50. doi: 10.1001/archinte.160.17.2645.

    PMID: 10999979RESULT

  • Massie BM. The year in heart failure: 2004. J Card Fail. 2005 Feb;11(1):1-6. doi: 10.1016/j.cardfail.2005.01.001. No abstract available.

    PMID: 15704055RESULT

  • Massie BM. Isosorbide dinitrate plus hydralazine was effective for advanced heart failure in black patients. ACP J Club. 2005 Mar-Apr;142(2):37. No abstract available.

    PMID: 15739984RESULT

  • Teerlink JR, Massie BM. Nesiritide and worsening of renal function: the emperor's new clothes? Circulation. 2005 Mar 29;111(12):1459-61. doi: 10.1161/01.CIR.0000160874.48045.54. No abstract available.

    PMID: 15795361RESULT

  • Massie BM. Heart failure trials: are they becoming impractical? J Card Fail. 2005 Apr;11(3):161-3. doi: 10.1016/j.cardfail.2005.03.001. No abstract available.

    PMID: 15812741RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Barry M Massie, MD

    San Francisco VA Medical Center, San Francisco, CA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Start

November 1, 2005

Study Completion

May 1, 2007

Last Updated

April 7, 2015

Record last verified: 2005-12

Locations

US(2)