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Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas

Primary Purpose

Heart Failure, Beta-blocker Treatment

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GTelephone-administered Cognitive-Behavioral Therapy (T-CBT)
Provider education, computer reminders, nurse case management
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria:

Sites / Locations

  • VA Northern California Health Care System, Mather, CA
  • San Francisco VA Medical Center, San Francisco, CA

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2001
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00012974
Brief Title
Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas
Official Title
Innovative Strategies for Implementing New CHF Guideline Recommendations
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
More that 20% of patients in primary care have depressive disorders. While primary care is the principal venue for treatment for depression, fewer than 25% of depressed patients receive adequate treatment for their depression. These outcomes can be worse when there are barriers to treatment such as living in a rural area. Several studies have found that given a choice, about two-thirds of depressed primary care patients prefer psychotherapy or counseling over antidepressant medication. This is a controlled, randomized trial in which subjects meeting criteria for major depressive disorder (MDD) from primary care settings in VISN 21 including CBOCs will be randomly assigned to one of two conditions: 1) a 16-session manualized telephone administered cognitive behavioral therapy (T-CBT) delivered over 24 weeks or 2) a treatment-as-usual (TAU) condition. Telephone-administered cognitive behavioral therapy (T-CBT) is an intervention aimed at improving coping skills and social functioning. It is divided into two phases: 1) an initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and 2) a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains. T-CBT, administered by doctoral level psychologists, will be compared to a treatment-as-usual (TAU) condition that controls for the natural course of depression during the course of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Beta-blocker Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
GTelephone-administered Cognitive-Behavioral Therapy (T-CBT)
Intervention Type
Procedure
Intervention Name(s)
Provider education, computer reminders, nurse case management
Primary Outcome Measure Information:
Title
Reduction in severity of depression; scores on depression rating scales at baseline, 12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Maintenance of treatment gains at 6 month follow-up (week 48).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry M Massie, MD
Organizational Affiliation
San Francisco VA Medical Center, San Francisco, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Northern California Health Care System, Mather, CA
City
Sacramento
State/Province
California
ZIP/Postal Code
95655
Country
United States
Facility Name
San Francisco VA Medical Center, San Francisco, CA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12016627
Citation
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.
Results Reference
result
PubMed Identifier
11911756
Citation
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.
Results Reference
result
PubMed Identifier
11832662
Citation
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.
Results Reference
result
PubMed Identifier
11561221
Citation
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.
Results Reference
result
PubMed Identifier
10723976
Citation
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.
Results Reference
result
PubMed Identifier
10618557
Citation
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.
Results Reference
result
PubMed Identifier
12151474
Citation
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.
Results Reference
result
PubMed Identifier
11176729
Citation
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.
Results Reference
result
PubMed Identifier
10843268
Citation
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.
Results Reference
result
PubMed Identifier
12140805
Citation
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.
Results Reference
result
PubMed Identifier
12140801
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
11755290
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
10999979
Citation
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.
Results Reference
result
PubMed Identifier
15704055
Citation
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. Erratum In: J Card Fail. 2005 Apr;11(3):246.
Results Reference
result
PubMed Identifier
15739984
Citation
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.
Results Reference
result
PubMed Identifier
15795361
Citation
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.
Results Reference
result
PubMed Identifier
15812741
Citation
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.
Results Reference
result

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Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas

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