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Behavioral Treatments for Chronic Pain

Primary Purpose

Intractable Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-behavioral therapy
Acceptance-based therapy
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intractable Pain focused on measuring Behavior therapy, Chronic pain, Cognitive therapy, Meditation, Mindfulness, Psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years old or older;
  • Proficient in English;
  • Willing and able to provide written informed consent (proposed informed consent form attached as Appendix A);
  • Diagnosis of chronic benign pain as a secondary condition associated with a primary impairment due to a traumatic injury or congenital or acquired disorder as verified by a study physician after a medical diagnostic evaluation;
  • Average pain severity rated > 4/10 with resulting functional limitations; and
  • Pain duration of at least 6 months.

Exclusion Criteria:

  • Participation in psychotherapy for pain the past 2 months;
  • Serious, unstable medical illness for which inpatient hospitalization is likely over the next 3 months; and
  • The following DSM-IV diagnoses or active problems within the past 6 months noted in the patient's CPRS medical record or diagnosed during a structured psychiatric interview: 1) schizophrenia; 2) other psychotic disorder; 3) bipolar disorder; 4) organic mental disorder; 5) borderline or antisocial personality disorder; or 6) alcohol or substance abuse or dependence.

Sites / Locations

  • VA San Diego Healthcare System, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cognitive Behavioral Therapy

Acceptance-Based Therapy

Arm Description

8 group-administered sessions of Cognitive-Behavioral Therapy

8 group-administered sessions of Acceptance-based therapy

Outcomes

Primary Outcome Measures

Brief Pain Inventory
This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain.

Secondary Outcome Measures

West Haven-Yale Multidimensional Pain Inventory - Activity Subscales
This questionnaire measures levels of activity that can be affected by pain. Full measure has a range of 0-6, with higher scores indicating higher levels of activity.
SF-12
This questionnaire measures quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life.
Beck Depression Inventory
This questionnaire measures depressive symptoms. Scores range from 0 to 63, with higher scores indicating higher levels of depressive symptoms.
Pain Anxiety Symptom Scale - 20
This questionnaire measures pain-related anxiety. Scores range from 0 to 100, with higher scores indicating higher levels of anxiety.

Full Information

First Posted
August 31, 2006
Last Updated
March 26, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00371865
Brief Title
Behavioral Treatments for Chronic Pain
Official Title
Acceptance-Based Treatment for Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to test a brief, group-administered psychosocial intervention to reduce interference of pain with daily life, emotional distress, and pain intensity, and improve quality of life and physical activity levels in individuals with chronic pain.
Detailed Description
Chronic pain affects at least 15% of the veteran population and represents a high priority for the VA. In addition to primary pain conditions, chronic pain is a common secondary condition resulting from battlefield injuries, traumatic accidents, and congenital and acquired disorders. Unlike most forms of acute pain, treatment options available for patients suffering from chronic pain frequently offer only short-term or partial relief from symptoms. The focus of rehabilitative intervention thus becomes the reduction of disability and emotional distress and improvement in quality of life and activity levels. Chronic pain rehabilitation has evolved from a primarily one-dimensional, medically oriented approach to a multidisciplinary approach that incorporates a biopsychosocial formulation to pain management with physiological, cognitive, behavioral, and emotional components. This conceptualization of pain recognizes that multiple intervention modalities, including psychosocial approaches, are required when providing treatment to chronic pain patients. A relatively new psychosocial approach to chronic pain management and rehabilitation involves acceptance of pain-related experiences. The Acceptance-based Therapy (AT) model is based on the theory that attempts to escape, avoid, or control negative experiences that cannot be changed, such as chronic pain, may paradoxically contribute to the increased experience of them. Instead of seeking to control the negative experience, AT teaches individuals to use mindfulness strategies to enlarge the scope of experience beyond pain and to engage in behaviors that are consistent with personal values and goals when total elimination of pain or other negative experiences is not possible. Empirical support for acceptance-based approaches to chronic pain management is growing. Data from one of the first comparisons of AT to a well-established psychosocial intervention, Cognitive-Behavioral Therapy (CBT), performed at VASDHS by the PI, suggests that AT may be superior to CBT as an adjunctive treatment for chronic pain. The proposed study assembles a multidisciplinary team with extensive experience in chronic pain interventions research to evaluate the benefits of a brief, manualized group-administered psychosocial intervention which could be easily integrated into multidisciplinary pain rehabilitation programs throughout the VA system to reduce disability in veterans with chronic pain secondary to other conditions. Specifically, we propose to examine the effects of a promising new chronic pain intervention based on AT principles on the primary outcome of pain interference and secondary outcomes of emotional distress, quality of life, physical activity, pain intensity, and treatment satisfaction among 94 veterans with chronic benign pain as a secondary condition. The AT intervention will be compared with treatment as usual (TAU) in a within-subjects design and with CBT in a randomized, between-subjects design. Outcomes include an objective measure of physical activity, actigraphy, as well as self-reported measures and will be evaluated at baseline, 6 weeks (after a TAU phase), 12 weeks (after treatment), and at a 6-month follow-up period to investigate maintenance of gains. The study design also allows for an investigation of hypothesized mechanisms of change, acceptance (for AT) and perceived pain control (for CBT). Thus, the proposed project has the potential to enhance the current VA standard of care as well as to add to the scientific literature on psychological models and rehabilitation of chronic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intractable Pain
Keywords
Behavior therapy, Chronic pain, Cognitive therapy, Meditation, Mindfulness, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
8 group-administered sessions of Cognitive-Behavioral Therapy
Arm Title
Acceptance-Based Therapy
Arm Type
Experimental
Arm Description
8 group-administered sessions of Acceptance-based therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Other Intervention Name(s)
CBT
Intervention Description
8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
Intervention Type
Behavioral
Intervention Name(s)
Acceptance-based therapy
Other Intervention Name(s)
ACT
Intervention Description
8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
Primary Outcome Measure Information:
Title
Brief Pain Inventory
Description
This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain.
Time Frame
12 weeks (post treatment)
Secondary Outcome Measure Information:
Title
West Haven-Yale Multidimensional Pain Inventory - Activity Subscales
Description
This questionnaire measures levels of activity that can be affected by pain. Full measure has a range of 0-6, with higher scores indicating higher levels of activity.
Time Frame
12 weeks (post treatment)
Title
SF-12
Description
This questionnaire measures quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life.
Time Frame
12 weeks (post treatment)
Title
Beck Depression Inventory
Description
This questionnaire measures depressive symptoms. Scores range from 0 to 63, with higher scores indicating higher levels of depressive symptoms.
Time Frame
12 weeks (post treatment)
Title
Pain Anxiety Symptom Scale - 20
Description
This questionnaire measures pain-related anxiety. Scores range from 0 to 100, with higher scores indicating higher levels of anxiety.
Time Frame
12 weeks (post treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years old or older; Proficient in English; Willing and able to provide written informed consent (proposed informed consent form attached as Appendix A); Diagnosis of chronic benign pain as a secondary condition associated with a primary impairment due to a traumatic injury or congenital or acquired disorder as verified by a study physician after a medical diagnostic evaluation; Average pain severity rated > 4/10 with resulting functional limitations; and Pain duration of at least 6 months. Exclusion Criteria: Participation in psychotherapy for pain the past 2 months; Serious, unstable medical illness for which inpatient hospitalization is likely over the next 3 months; and The following DSM-IV diagnoses or active problems within the past 6 months noted in the patient's CPRS medical record or diagnosed during a structured psychiatric interview: 1) schizophrenia; 2) other psychotic disorder; 3) bipolar disorder; 4) organic mental disorder; 5) borderline or antisocial personality disorder; or 6) alcohol or substance abuse or dependence.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie L Wetherell, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21683527
Citation
Wetherell JL, Afari N, Rutledge T, Sorrell JT, Stoddard JA, Petkus AJ, Solomon BC, Lehman DH, Liu L, Lang AJ, Atkinson HJ. A randomized, controlled trial of acceptance and commitment therapy and cognitive-behavioral therapy for chronic pain. Pain. 2011 Sep;152(9):2098-2107. doi: 10.1016/j.pain.2011.05.016. Epub 2011 Jun 17.
Results Reference
result
PubMed Identifier
22200521
Citation
Mostoufi SM, Afari N, Ahumada SM, Reis V, Wetherell JL. Health and distress predictors of heart rate variability in fibromyalgia and other forms of chronic pain. J Psychosom Res. 2012 Jan;72(1):39-44. doi: 10.1016/j.jpsychores.2011.05.007. Epub 2011 Jun 30.
Results Reference
result

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Behavioral Treatments for Chronic Pain

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