Behavioral Treatments for Chronic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00371865
First received: August 31, 2006
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Intractable Pain
Behavioral: Cognitive-behavioral therapy
Behavioral: Acceptance-based therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acceptance-Based Treatment for Chronic Pain

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Brief Pain Inventory [ Time Frame: 12 weeks (post treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • West Haven-Yale Multidimensional Pain Inventory - Activity subscales [ Time Frame: 12 weeks (post treatment) ] [ Designated as safety issue: No ]
  • SF-12 [ Time Frame: 12 weeks (post treatment) ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: 12 weeks (post treatment) ] [ Designated as safety issue: No ]
  • Pain Anxiety Symptom Scale - 20 [ Time Frame: 12 weeks (post treatment) ] [ Designated as safety issue: No ]
  • McGill Pain Questionnaire [ Time Frame: 12 weeks (post treatment) ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index [ Time Frame: 12 weeks (post treatment) ] [ Designated as safety issue: No ]
  • CSQ-R Catastrophizing subscale [ Time Frame: 12 weeks (post treatment) ] [ Designated as safety issue: No ]
  • Pain Behavior Check List [ Time Frame: 12 weeks (post treatment) ] [ Designated as safety issue: No ]
  • Actigraphy [ Time Frame: 12 weeks (post treatment) ] [ Designated as safety issue: No ]
  • Heart rate variability [ Time Frame: 12 weeks (post treatment) ] [ Designated as safety issue: No ]
  • Tender Point examination [ Time Frame: 12 weeks (post treatment) ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: October 2006
Study Completion Date: September 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
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 Name: CBT
Experimental: Arm 2
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 Name: ACT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371865

Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
Investigators
Principal Investigator: Julie Wetherell, PhD VA San Diego Healthcare System, San Diego
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00371865     History of Changes
Other Study ID Numbers: F4306-I
Study First Received: August 31, 2006
Last Updated: January 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Behavior therapy
Chronic pain
Cognitive therapy
Meditation
Mindfulness
Psychotherapy

Additional relevant MeSH terms:
Pain, Intractable
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014