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Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00386243
First received: October 6, 2006
Last updated: April 29, 2014
Last verified: April 2014
Results First Received: September 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Low Back Pain
Pain
Pain, Intractable
Interventions: Behavioral: Cognitive behavioral therapy
Behavioral: Pain self-management program
Drug: Co-Analgesic Therapy
Drug: Opioid Analgesics

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment began December 2007 and concluded June 2011. The final assessment was completed by May 2012. All subjects were recruited from the Roudebush VA Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Usual Care Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
Stepped Care

Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.

Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.

Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.

Co-Analgesic Therapy


Participant Flow:   Overall Study
    Usual Care     Stepped Care  
STARTED     121     121  
COMPLETED     114     108  
NOT COMPLETED     7     13  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1 Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
Arm 2

Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.

Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.

Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.

Co-Analgesic Therapy

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  121     121     242  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     121     120     241  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  38.2  ± 10.5     36.4  ± 10.1     36.7  ± 10.3  
Gender  
[units: participants]
     
Female     16     12     28  
Male     105     109     214  
Region of Enrollment  
[units: participants]
     
United States     121     121     242  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Roland-Morris Disability Questionnaire   [ Time Frame: at baseline and 9 months ]

2.  Primary:   Brief Pain Inventory (Interference)   [ Time Frame: Baseline and 9 months ]

3.  Secondary:   Psychological Distress (PHQ-9, MCS Score of SF-12, PRIME-MD Anxiety, PTSD Checklist (PCL-17))   [ Time Frame: at baseline, 3, 6, and 9 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Clinical Response (Global Rating of Change)   [ Time Frame: at baseline, 3, 6, and 9 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Work Function (Work and Health Interview)   [ Time Frame: at baseline, 3, 6, and 9 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Generic HRQL (SF-12)   [ Time Frame: at baseline, 3, 6, and 9 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Pain Self-efficacy (Arthritis Self-efficacy Scale)   [ Time Frame: at baseline, 3, 6, and 9 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Single VA Center; May not generalize to non-VA samples


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Matthew J. Bair, MD MS
Organization: Center on Implementing Evidence Based Practice
phone: 317-988-2058
e-mail: mbair@iupui.edu


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00386243     History of Changes
Obsolete Identifiers: NCT00449475
Other Study ID Numbers: F4437-I
Study First Received: October 6, 2006
Results First Received: September 25, 2013
Last Updated: April 29, 2014
Health Authority: United States: Federal Government