NCT00005575

Brief Summary

Approximately 75,000-150,000 patients each year in the United States undergo intensive cardiac evaluations for symptoms of angina-like chest pain that produce no positive findings. These patients often have high levels of disability and suffering and account for $250,000,000-$500,000,000 in estimated health care costs each year. There is some evidence from randomized, controlled trials that a pharmacologic agent, imipramine, and a program of training in pain coping skills and cognitive-behavioral therapy (CBT) both produce short-term reductions in pain intensity. However, no studies have compared the effects of these two treatments on measures of pain, suffering, and disability at post-treatment and over a one-year follow-up period. Our investigation is a 16-week, randomized controlled outcome study of these interventions and their respective placebo control procedures. One hundred and sixty patients are being recruited for this study. We will assess the effects of our interventions on patients' pain levels, quality of life, and health care resource usage at baseline, post-treatment, 6-month follow-up, and at 12-month follow-up. We will evaluate the clinical significance of our treatment effects as well as their statistical significance.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 1999

Typical duration for phase_3

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

Study Start

First participant enrolled

January 1, 1999

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2000

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

First QC Date

May 1, 2000

Last Update Submit

January 12, 2010

Conditions

Chest Pain

Keywords

ImipramineCognitive-Behavioral Therapy

Interventions

ImipramineDRUG
Cognitive-behavior therapyBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Substernal chest pain at least 2X per week for at least 3 months;
  • Angiographic evidence of normal or non-obstructive (\<50% luminal diameter narrowing) coronary arteries among subjects \> 40 years of age; OR Normal exercise stress tests, normal echocardiogram, and cardiologist evaluation that symptoms are not cardiac in origin among subjects \< 40 years of age;
  • Gastroesophageal reflux disease ruled out by 24-hour pH monitoring, endoscopy, or 1-month trial of anti-reflux therapy with omeprazole 20 mg bid;
  • Pain threshold levels for esophageal balloon distention must be 12 ml.

You may not qualify if:

  • Mitral valve prolapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (3)

  • Bradley LA, Richter JE, Scarinci IC, Haile JM, Schan CA. Psychosocial and psychophysical assessments of patients with unexplained chest pain. Am J Med. 1992 May 27;92(5A):65S-73S. doi: 10.1016/0002-9343(92)80059-9.

    PMID: 1595768BACKGROUND

  • Mayou RA, Bryant BM, Sanders D, Bass C, Klimes I, Forfar C. A controlled trial of cognitive behavioural therapy for non-cardiac chest pain. Psychol Med. 1997 Sep;27(5):1021-31. doi: 10.1017/s0033291797005254.

    PMID: 9300508BACKGROUND

  • Cannon RO 3rd, Quyyumi AA, Mincemoyer R, Stine AM, Gracely RH, Smith WB, Geraci MF, Black BC, Uhde TW, Waclawiw MA, et al. Imipramine in patients with chest pain despite normal coronary angiograms. N Engl J Med. 1994 May 19;330(20):1411-7. doi: 10.1056/NEJM199405193302003.

    PMID: 8159194BACKGROUND

MeSH Terms

Conditions

Chest Pain

Interventions

ImipramineCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Laurence A. Bradley

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

May 1, 2000

First Posted

May 2, 2000

Study Start

January 1, 1999

Study Completion

December 1, 2002

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations

US(1)