Behavioral Treatments for Chronic Pain

March 26, 2015 updated by: US Department of Veterans Affairs

Acceptance-Based Treatment for Chronic Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive Behavioral Therapy
8 group-administered sessions of Cognitive-Behavioral Therapy
Behavioral: Cognitive-behavioral therapy
8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
Other Names:
  • CBT
Experimental: Acceptance-Based Therapy
8 group-administered sessions of Acceptance-based therapy
Behavioral: Acceptance-based therapy
8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
Other Names:
  • ACT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory
Time Frame: 12 weeks (post treatment)
This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain.
12 weeks (post treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
West Haven-Yale Multidimensional Pain Inventory - Activity Subscales
Time Frame: 12 weeks (post treatment)
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.
12 weeks (post treatment)
SF-12
Time Frame: 12 weeks (post treatment)
This questionnaire measures quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life.
12 weeks (post treatment)
Beck Depression Inventory
Time Frame: 12 weeks (post treatment)
This questionnaire measures depressive symptoms. Scores range from 0 to 63, with higher scores indicating higher levels of depressive symptoms.
12 weeks (post treatment)
Pain Anxiety Symptom Scale - 20
Time Frame: 12 weeks (post treatment)
This questionnaire measures pain-related anxiety. Scores range from 0 to 100, with higher scores indicating higher levels of anxiety.
12 weeks (post treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Julie L Wetherell, PhD, VA San Diego Healthcare System, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 31, 2006

First Submitted That Met QC Criteria

August 31, 2006

First Posted (Estimate)

September 4, 2006

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F4306-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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