Behavioral Treatments for Chronic Pain

NCT ID: NCT00371865

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-09-30

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.

Conditions

Intractable Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Behavioral Therapy

8 group-administered sessions of Cognitive-Behavioral Therapy

Group Type: ACTIVE_COMPARATOR

Cognitive-behavioral therapy

Intervention Type: BEHAVIORAL

8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving

Acceptance-Based Therapy

8 group-administered sessions of Acceptance-based therapy

Group Type: EXPERIMENTAL

Acceptance-based therapy

Intervention Type: BEHAVIORAL

8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action

Interventions

Cognitive-behavioral therapy

8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving

Intervention Type: BEHAVIORAL

Acceptance-based therapy

8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT; ACT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie L Wetherell, PhD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego

Locations

VA San Diego Healthcare System, San Diego

San Diego, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21683527 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22200521 (View on PubMed)

Other Identifiers

F4306-I

Identifier Type: -

Identifier Source: org_study_id