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Behavioral Treatments for Chronic Pain

Acceptance-Based Treatment for Chronic Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00371865
Enrollment
114
Registered
2006-09-04
Start date
2006-10-31
Completion date
2009-09-30
Last updated
2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intractable Pain

Keywords

Behavior therapy, Chronic pain, Cognitive therapy, Meditation, Mindfulness, Psychotherapy

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.

Interventions

BEHAVIORALCognitive-behavioral therapy

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

BEHAVIORALAcceptance-based therapy

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

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Brief Pain Inventory12 weeks (post treatment)This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain.

Secondary

MeasureTime frameDescription
West Haven-Yale Multidimensional Pain Inventory - Activity Subscales12 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.
SF-1212 weeks (post treatment)This questionnaire measures quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life.
Beck Depression Inventory12 weeks (post treatment)This questionnaire measures depressive symptoms. Scores range from 0 to 63, with higher scores indicating higher levels of depressive symptoms.
Pain Anxiety Symptom Scale - 2012 weeks (post treatment)This questionnaire measures pain-related anxiety. Scores range from 0 to 100, with higher scores indicating higher levels of anxiety.

Countries

United States

Participant flow

Participants by arm

ArmCount
Cognitive Behavioral Therapy
8 group-administered sessions of Cognitive-Behavioral Therapy Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
57
Acceptance-Based Therapy
8 group-administered sessions of Acceptance-based therapy Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
57
Total114

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLack of Efficacy02
Overall StudyProtocol Violation32
Overall StudyWithdrawal by Subject1210

Baseline characteristics

CharacteristicCognitive Behavioral TherapyAcceptance-Based TherapyTotal
Age, Continuous54.9 years
STANDARD_DEVIATION 12.5
54.9 years
STANDARD_DEVIATION 12.5
54.9 years
STANDARD_DEVIATION 12.5
Race/Ethnicity, Customized
NonHispanic white
38 participants39 participants77 participants
Race/Ethnicity, Customized
Other
19 participants18 participants37 participants
Region of Enrollment
United States
57 participants57 participants114 participants
Sex: Female, Male
Female
29 Participants29 Participants58 Participants
Sex: Female, Male
Male
28 Participants28 Participants56 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 500 / 49
serious
Total, serious adverse events
0 / 500 / 49

Outcome results

Primary

Brief Pain Inventory

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

Time frame: 12 weeks (post treatment)

ArmMeasureValue (MEAN)Dispersion
Arm 1Brief Pain Inventory4.5 units on a scaleStandard Deviation 2.7
Arm 2Brief Pain Inventory5.1 units on a scaleStandard Deviation 2.4
p-value: 0.27Mixed Models Analysis
Secondary

Beck Depression Inventory

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)

ArmMeasureValue (MEAN)Dispersion
Arm 1Beck Depression Inventory13.2 units on a scaleStandard Deviation 11.1
Arm 2Beck Depression Inventory17.8 units on a scaleStandard Deviation 12.2
p-value: 0.26Mixed Models Analysis
Secondary

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.

Time frame: 12 weeks (post treatment)

ArmMeasureValue (MEAN)Dispersion
Arm 1Pain Anxiety Symptom Scale - 2037.9 units on a scaleStandard Deviation 20.7
Arm 2Pain Anxiety Symptom Scale - 2041.5 units on a scaleStandard Deviation 23.4
p-value: 0.9Mixed Models Analysis
Secondary

SF-12

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)

ArmMeasureValue (MEAN)Dispersion
Arm 1SF-1244.9 units on a scaleStandard Deviation 12.1
Arm 2SF-1241.0 units on a scaleStandard Deviation 13.6
p-value: 0.13Mixed Models Analysis
Secondary

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.

Time frame: 12 weeks (post treatment)

ArmMeasureValue (MEAN)Dispersion
Arm 1West Haven-Yale Multidimensional Pain Inventory - Activity Subscales2.3 units on a scaleStandard Deviation 0.8
Arm 2West Haven-Yale Multidimensional Pain Inventory - Activity Subscales2.0 units on a scaleStandard Deviation 0.8
p-value: 0.9Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026