Pain and Substance Use Disorders (PSUD)

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: December 10, 2014
Last verified: December 2014
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
No text entered.

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 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-shw                 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  
[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.



  Outcome Measures

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


  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: December 10, 2014
Health Authority: United States: Federal Government