Intractable PainNCT00371865
Behavioral Treatments for Chronic Pain
A study testing Cognitive-behavioral therapy and Acceptance-based therapy in people with Intractable Pain, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intractable Pain
- What is being tested?
- Cognitive-behavioral therapy and Acceptance-based therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego
San Diego, California, 92161
About this study
Official title: 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.
Read the 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
- Being tested
- Cognitive-behavioral therapy, Acceptance-based therapy
- Keywords
- Behavior therapy, Chronic pain, Cognitive therapy, Meditation, Mindfulness, Psychotherapy
- Medical subject headings
- Pain, Intractable, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapyBehavioural
Also called CBT
8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
Acceptance-based therapyBehavioural
Also called ACT
8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Active comparator | 8 group-administered sessions of Cognitive-Behavioral Therapy Receives: Behavioral: Cognitive-behavioral therapy |
| Acceptance-Based Therapy | Experimental | 8 group-administered sessions of Acceptance-based therapy Receives: Behavioral: Acceptance-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain.
Measured: 12 weeks (post treatment)
Secondary outcomes (4)
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.
Measured: 12 weeks (post treatment)
SF-12
This questionnaire measures quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: 12 weeks (post treatment)
Beck Depression Inventory
This questionnaire measures depressive symptoms. Scores range from 0 to 63, with higher scores indicating higher levels of depressive symptoms.
Measured: 12 weeks (post treatment)
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.
Measured: 12 weeks (post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intractable PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julie L Wetherell, PhD, Principal investigator, VA San Diego Healthcare System, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371865
- Sponsor's protocol ID
- F4306-I
- Status last verified
- Mar 2015
- First submitted
- 31 Aug 2006
- Last updated
- 10 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21683527Mostoufi 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.
PubMed 22200521
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance-Based Treatment for Chronic Pain
- ClinicalTrials.gov ID
- NCT00371865
- Acronym / sponsor ID
- F4306-I
- Conditions
- Intractable Pain
- Keywords
- Behavior therapy, Chronic pain, Cognitive therapy, Meditation, Mindfulness, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Sep 2006 (estimated)
- Results
- Posted 10 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive-behavioral therapy8 group-administered sessions of Cognitive-Behavioral Therapy |
| Acceptance-Based Therapy | Experimental | Behavioral: Acceptance-based therapy8 group-administered sessions of Acceptance-based therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapyAlso: CBT8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving | Behavioural | Cognitive Behavioral Therapy |
| Acceptance-based therapyAlso: ACT8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action | Behavioural | Acceptance-Based Therapy |
Primary outcome
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.
4 secondary outcomes
West Haven-Yale Multidimensional Pain Inventory - Activity Subscales
Time frame: 12 weeks (post treatment)
SF-12
Time frame: 12 weeks (post treatment)
Beck Depression Inventory
Time frame: 12 weeks (post treatment)
Pain Anxiety Symptom Scale - 20
Time frame: 12 weeks (post treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21683527Wetherell 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 publication: PubMed 22200521Mostoufi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie L Wetherell, PhD principal investigator
VA San Diego Healthcare System, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy and Acceptance-based therapy in people with Intractable Pain, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (time frame: 12 weeks (post treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00371865, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.