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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00386243
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : May 26, 2014
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 242
Recruitment Details 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  
Arm/Group Title Usual Care Stepped Care
Hide Arm/Group Description 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.

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

Period Title: Overall Study
Started 121 121
Completed 114 108
Not Completed 7 13
Arm/Group Title Usual Care Stepped Care Total
Hide Arm/Group Description 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.

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 of all reporting groups
Overall Number of Baseline Participants 121 121 242
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 121 participants 242 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
121
 100.0%
120
  99.2%
241
  99.6%
>=65 years
0
   0.0%
1
   0.8%
1
   0.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants 121 participants 242 participants
38.2  (10.5) 36.4  (10.1) 36.7  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 121 participants 242 participants
Female
16
  13.2%
12
   9.9%
28
  11.6%
Male
105
  86.8%
109
  90.1%
214
  88.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 121 participants 121 participants 242 participants
121 121 242
1.Primary Outcome
Title Roland-Morris Disability Questionnaire
Hide Description This is a 24-item pain specific disability questionnaire consisting of 24 questions which are related specifically to physical functions that are likely to be affected by back pain. The questionnaire is scored by adding up the number of items checked by the subject (0-24 range). Greater levels of disability are reflected by higher numbers.
Time Frame at baseline and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
Arm/Group Title Usual Care Stepped Care
Hide Arm/Group Description:
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.

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

Overall Number of Participants Analyzed 120 121
Mean (Standard Deviation)
Unit of Measure: scores on a scale
baseline Number Analyzed 120 participants 121 participants
13.7  (4.7) 14.0  (4.3)
9 months Number Analyzed 114 participants 108 participants
12.1  (6.4) 10.6  (6.3)
2.Primary Outcome
Title Brief Pain Inventory (Interference)
Hide Description This is an 7-item measure that provides scores for pain-related functional impairment. The seven (7) pain interference items are rated on a simple numeric rating scale from 0-10. On the scale 0 represents "no interference" and 10 is "completely interferes". The pain interference score is achieved by taking the total of all seven (7) scores and dividing it by the number of items (7).
Time Frame Baseline and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
Arm/Group Title Usual Care Stepped Care
Hide Arm/Group Description:
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.

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

Overall Number of Participants Analyzed 120 121
Mean (Standard Deviation)
Unit of Measure: units on a scale
At Baseline Number Analyzed 120 participants 121 participants
5.4  (2.4) 5.3  (2.1)
At 9 months Number Analyzed 114 participants 108 participants
4.5  (2.7) 3.8  (2.6)
3.Secondary Outcome
Title SF-Mental Component Summary (MCS)
Hide Description This scale provides a measure of mental health quality of life. It is measure on a 0 to 100 scale with higher scores representing better mental health
Time Frame Baseline and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
Arm/Group Title Usual Care Stepped Care
Hide Arm/Group Description:
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.

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

Overall Number of Participants Analyzed 120 121
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 120 participants 121 participants
41.4  (13.2) 41.9  (12.1)
9 months Number Analyzed 114 participants 108 participants
42.4  (12.5) 42.2  (13.1)
4.Secondary Outcome
Title PHQ-9 Depression
Hide Description This measure assesses depression symptoms on a 0 to 27 scale with higher scores representing more severe depression
Time Frame Baseline and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
Arm/Group Title Usual Care Stepped Care
Hide Arm/Group Description:
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.

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

Overall Number of Participants Analyzed 120 121
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline Number Analyzed 120 participants 121 participants
11.3  (5.64) 11.05  (6.18)
9 months Number Analyzed 114 participants 108 participants
10.0  (6.34) 9.45  (6.84)
5.Secondary Outcome
Title PTSD Checklist-17 Civilian Version (PCL-C)
Hide Description The PCL-17 is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Two versions of the PCL exist: PCL-Military and PCL-Civilian.We used the PCL-Civilian version because it addresses the broadest range of possible events as the traumatic stressor. The PCL-C has demonstrated strong reliability and validity in multiple samples. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". Higher scores represent more severe PTSD symptoms.
Time Frame Baseline and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
Arm/Group Title Usual Care Stepped Care
Hide Arm/Group Description:
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.

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

Overall Number of Participants Analyzed 120 121
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 120 participants 121 participants
25.15  (19.74) 27.62  (19.24)
9 months Number Analyzed 114 participants 108 participants
22.71  (19.15) 24.28  (19.07)
6.Secondary Outcome
Title GAD-7 Anxiety Score
Hide Description This 7-item scale assesses anxiety symptoms on a 0 to 21 scale with higher scores representing more severe anxiety symptoms
Time Frame Baseline and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
Arm/Group Title Usual Care Stepped Care
Hide Arm/Group Description:
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.

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

Overall Number of Participants Analyzed 120 121
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 120 participants 121 participants
8.66  (5.22) 8.95  (5.30)
9 months Number Analyzed 114 participants 108 participants
7.85  (5.5) 7.89  (5.55)
7.Secondary Outcome
Title Pain Catastrophizing Scale (PCS)
Hide Description The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0-52 with higher scores representing more pain catastrophizing.
Time Frame Baseline and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis
Arm/Group Title Usual Care Stepped Care
Hide Arm/Group Description:
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.

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

Overall Number of Participants Analyzed 120 121
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 120 participants 121 participants
21.81  (12.38) 21.44  (12.26)
9 months Number Analyzed 114 participants 108 participants
18.40  (13.46) 16.63  (12.29)
Time Frame The time frame in which adverse event data were collected was from the baseline evaluation to the 9-month assessment. Therefore, the assessment period was for 9 months which was through study completion.
Adverse Event Reporting Description There were 7 Serious Adverse Events reported to the IRB according to the VA definition of a serious adverse event. VA requires reporting of any hospital stay longer than 24 hours by any subject enrolled. There were 7. The IRB did not find these to be Serious Adverse Events resulting from the study and these are called "VA Events" officially.
 
Arm/Group Title Usual Care Stepped Care
Hide Arm/Group Description 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.

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

All-Cause Mortality
Usual Care Stepped Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care Stepped Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/121 (0.83%)      6/121 (4.96%)    
Nervous system disorders     
hospitalization for longer than 24 hours  1 [1]  0/121 (0.00%)  0 2/121 (1.65%)  2
Psychiatric disorders     
hospital stay longer than 24 hours  1 [2]  1/121 (0.83%)  1 3/121 (2.48%)  3
Respiratory, thoracic and mediastinal disorders     
hospitalization for longer than 24 hours  1 [3]  0/121 (0.00%)  0 1/121 (0.83%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, ICD-9
[1]
IRB found these not to be serious adverse events
[2]
IRB found that this event not to be a serious adverse event
[3]
IRB concluded that this did not meet their definition for a serious adverse event
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Usual Care Stepped Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/121 (0.00%)      4/121 (3.31%)    
Gastrointestinal disorders     
Medication side effects * 1 [1]  0/121 (0.00%)  0 2/121 (1.65%)  2
Nervous system disorders     
Medication side effects * 1 [2]  0/121 (0.00%)  0 2/121 (1.65%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, ICD-9
[1]
nause related to study medication
[2]
dizziness related to study medication
Single VA Center; May not generalize to non-VA samples
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Matthew J. Bair, MD MS
Organization: Center on Implementing Evidence Based Practice
Phone: 317-988-2058
EMail: mbair@iupui.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00386243     History of Changes
Obsolete Identifiers: NCT00449475
Other Study ID Numbers: F4437-I
First Submitted: October 6, 2006
First Posted: October 11, 2006
Results First Submitted: September 25, 2013
Results First Posted: May 26, 2014
Last Update Posted: July 3, 2019