Managing Chronic Pain in Veterans With Substance Use Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00982410
First received: September 21, 2009
Last updated: June 15, 2015
Last verified: June 2015
Results First Received: November 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Pain
Interventions: Behavioral: cognitive-behavioral treatment
Behavioral: educational supportive group

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cognitive Behavioral Treatment Group (CBT)

An intervention treatment group to manage pain and decrease substance use abuse/misuse

Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse

Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor Veterans Affairs Medical Center (VAMC). Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.

Educational Supportive Group

A control condition providing social support and education about pain and/or drug use.

Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle


Participant Flow for 3 periods

Period 1:   3-month Follow-up Assessment
    Cognitive Behavioral Treatment Group (CBT)     Educational Supportive Group  
STARTED     65     66  
COMPLETED     56     53  
NOT COMPLETED     9     13  
Could not reach to schedule                 8                 9  
Scheduled, no-show                 1                 2  
Withdrawal by Subject                 0                 2  

Period 2:   6-month Follow-up Assessment
    Cognitive Behavioral Treatment Group (CBT)     Educational Supportive Group  
STARTED     65 [1]   64 [2]
COMPLETED     59     53  
NOT COMPLETED     6     11  
Could not reach to schedule                 5                 7  
participant no transportation                 1                 0  
incarceration                 0                 2  
patent surgery                 0                 1  
scheduled, no-show                 0                 1  
[1] n=65 : intent to treat. Some persons missed follow-up assessment without withdrawing from study.
[2] n=2 persons withdrew before 3-mo. f/u, reducing pool of participants to N=64 with intent to treat.

Period 3:   12-month Follow-up Assessment
    Cognitive Behavioral Treatment Group (CBT)     Educational Supportive Group  
STARTED     65 [1]   64 [2]
COMPLETED     56     55  
NOT COMPLETED     9     9  
Death                 0                 2  
could not reach to schedule                 6                 5  
Withdrawal by Subject                 0                 1  
incarceration                 2                 1  
scheduled, no-show                 1                 0  
[1] n=65 : intent to treat. Some persons missed follow-up assessment without withdrawing from study.
[2] n=2 persons withdrew before 3-mo. f/u, reducing pool of participants to N=64 with intent to treat.



  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
Cognitive Behavioral Treatment Group

An intervention treatment group to manage pain and decrease substance use abuse/misuse

Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse

Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises.

Educational Supportive Group

A control condition providing social support and education about pain and/or drug use.

Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle

Total Total of all reporting groups

Baseline Measures
    Cognitive Behavioral Treatment Group     Educational Supportive Group     Total  
Number of Participants  
[units: participants]
  65     66     131  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     64     64     128  
>=65 years     1     2     3  
Age  
[units: years]
Mean (Standard Deviation)
  51.7  (9.2)     51.3  (10.1)     51.5  (9.6)  
Gender  
[units: participants]
     
Female     7     8     15  
Male     58     58     116  
Self-reported average pain level in the past week via NRS-1 [1]
[units: units on a scale]
Mean (Standard Deviation)
  7.15  (1.61)     7.09  (1.62)     7.14  (1.62)  
WHY-MPI: Pain Severity Score [2]
[units: units on a scale]
Mean (Standard Deviation)
  4.31  (0.97)     4.31  (0.89)     4.31  (0.94)  
WHY-MPI General Activity [3]
[units: units on a scale]
Mean (Standard Deviation)
  2.24  (0.82)     2.04  (0.89)     2.14  (0.86)  
CPSS: Self- efficacy for physical functioning (FSE score) [4]
[units: units on a scale]
Mean (Standard Deviation)
  63.9  (22.0)     60.6  (21.9)     62.3  (21.9)  
CPSS: self-efficacy for pain management (PSE score) [4]
[units: units on a scale]
Mean (Standard Deviation)
  50.2  (22.1)     42.1  (19.8)     46.3  (21.3)  
Alcohol abuse or alcohol dependence [5]
[units: participants]
     
Abuse or Dependence     38     35     73  
No Abuse; No Dependence     27     31     58  
Drug abuse or drug dependence [6]
[units: participants]
     
Any drug abuse or dependence     30     33     63  
No Abuse; No dependence     35     33     68  
Prescription opioid misuse [7]
[units: participants]
     
Ever misused Rx opioids     37     39     76  
Never misused Rx opioids     28     27     55  
[1] Rate your pain, on average over the past week. Scale ranging from 0 (no pain) to 10 (worst possible pain). Average pain within last week.
[2] To measure pain-severity, we will use the Interference subscale of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI). The WHYMPI/MPI is designed to be a brief, psychometrically-valid, and comprehensive assessment of the chronic pain experience for an individual. The WHY-MPI scores range from 0 to 6 with lower scores representing a better outcome.
[3] West Haven-Yale M Pain Inventory: Score is a composite construct designed to assess the extent to which physical pain impacts daily living. Aspects include ability to perform chores inside home, activities away from home, and social functioning. WHY-MPI General Activity Score ranges from 0-6; high scores represent better outcomes.
[4] The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain (Anderson et al. 1995). The CPSS has three primary subscales: self-efficacy for pain management (PSE), self-efficacy for physical function (FSE) and self-efficacy for coping with symptoms (CSE). These scales have high reliability. Scores range from 10-100, with higher scores representing a better outcome.
[5] University of Arkansas Substance Abuse Outcomes Module (SAOM; Smith et al. 1996). 25-item self-report measure designed to assess the severity of alcohol and drug problems (coefficient alpha = .9). Persons classified as alcohol abusers (a) had no dependence, but (b) did meet the criteria for abuse. Alcohol use questions concern the number of days of alcohol use, the average consumption per drinking day, the maximum consumption, and the number of binge days (more than five drinks consumed). Standard drinks are explained prior to asking these questions.
[6] University of Arkansas Substance Abuse Outcomes Module (SAOM; Smith et al. 1996). 25-item self-report measure designed to assess the severity of alcohol and drug problems. Persons classified as drug abusers (a) had no dependence, but (b) did meet the criteria for abuse on one or more substance. If a person met criteria for abuse on one substance and dependence on another, they were classified as drug-dependent. Persons with no abuse and no dependence did not meet criteria for abuse or dependence. Based on use of cannabis, cocaine, opioids, or stimulants in past 4 weeks.
[7] Binary variable; based on 4 COMM (17-item self-report measure of current aberrant drug-related behavior over the past 30 days and answer choices range from 0 (never) to 4 (often)), questions pertaining to a) taking more Rx opioids than prescribed, b) taking Rx opioids prescribed to someone else, c) borrowing Rx opioids from someone else, and d) using Rx opioids for non-pain symptoms. Persons reporting any history of doing any of these 4 things were classified into opioid misuse categories, and persons who answered "never" to all 4 questions were classified as not misusing opioids.



  Outcome Measures
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1.  Primary:   Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)   [ Time Frame: Baseline, 3-, 6-, & 12-months ]

2.  Primary:   The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)   [ Time Frame: Baseline, 3-,6-, 12-month ]

3.  Primary:   Alcohol Use   [ Time Frame: Baseline, 3-, 6-, 12- months ]

4.  Primary:   Drug Use   [ Time Frame: Baseline, 3-, 6-, 12- months ]

5.  Primary:   Pain Tolerance   [ Time Frame: Baseline, 3-,6-,12-months ]

6.  Secondary:   Self-efficacy of Pain Management   [ Time Frame: Baseline, 3-, 6-, 12- months ]

7.  Secondary:   Self-efficacy of Physical Functioning   [ Time Frame: Baseline, 3-, 6-, 12- months ]

8.  Secondary:   As-treated Analysis: Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)   [ Time Frame: Baseline, 3-, 6-, 12-months ]

9.  Secondary:   As-treated Analysis: The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)   [ Time Frame: Baseline, 3mo, 6mo, 12mo follow-up ]


  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
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  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: Dr. Mark Ilgen
Organization: Ann Arbor Veteran Affairs
phone: (734) 845-3646
e-mail: Mark.Ilgen@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00982410     History of Changes
Other Study ID Numbers: IAC 09-047
Study First Received: September 21, 2009
Results First Received: November 21, 2014
Last Updated: June 15, 2015
Health Authority: United States: Federal Government