PainNCT00127413
Integrated Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)
A study testing Cognitive Behavioral Therapy - Pain, Cognitive Behavioral Therapy-Integrated and Cognitive Processing Therapy - PTSD in people with Pain and Posttraumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of an integrated treatment for Veterans with comorbid chronic pain and posttraumatic stress disorder (PTSD). It is hypothesized that Veterans who receive the integrated treatment will report more positive outcomes than individuals who are assigned to treatment as… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Posttraumatic Stress Disorder
- What is being tested?
- Cognitive Behavioral Therapy - Pain, Cognitive Behavioral Therapy-Integrated and Cognitive Processing Therapy - PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients will be eligible for participation if they have chronic pain, defined as constant pain of at least six months duration with a neurologic or musculoskeletal etiology. Patients must also meet criteria for PTSD.
- Stability of pain and anxiety medications will be required for two months prior to study entry and during the active treatment and TAU phase.
Who cannot join
- Patients with life threatening or acute physical illness (e.g., cancer).
- Current alcohol or substance abuse or dependence. Veterans who have a history of alcohol or drug dependence but who have not had problematic use in the last six months will be included in the study.
- Current psychosis or suicidal ideation.
- Individuals seeking pain treatment such as surgical interventions will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Health Care System, Jamaica Plain
Boston, Massachusetts, 02130
About this study
Official title: Integrated Treatment for Chronic Pain and PTSD
The purpose of this study is to examine the efficacy of an integrated treatment for Veterans with comorbid chronic pain and posttraumatic stress disorder (PTSD). It is hypothesized that Veterans who receive the integrated treatment will report more positive outcomes than individuals who are assigned to treatment as usual, pain treatment, or PTSD treatment.
Read the detailed description
Chronic pain and post-traumatic stress disorder frequently co-occur and are associated with a significant level of affective distress, physical disability, and treatment resistance. However, no empirical studies have been conducted investigating the efficacy of a treatment tailored specifically for individuals with comorbid chronic pain and PTSD.
The primary objective of this study is to evaluate the efficacy of a cognitive-behavioral therapy approach for comorbid chronic pain and PTSD. A secondary objective of this study is to examine potential mechanisms of action that might mediate treatment outcome. It is hypothesized that:
1.a) Participants receiving integrated cognitive-behavioral treatment for chronic pain and PTSD will report significantly greater improvements on measures of pain, affective distress, and physical functioning from pre-treatment to post-treatment than participants in the Cognitive Behavioral Treatment for chronic pain, Cognitive Processing Therapy (CPT) for PTSD, or Treatment as Usual (TAU) conditions
1.b) All active treatments will be more effective at promoting improved outcomes than Treatment as Usual
- Participants receiving integrated cognitive-behavioral treatment for chronic pain and PTSD will report decreased symptoms of PTSD from pre-treatment to post-treatment when compared to participants in the other conditions.
- Participants receiving integrated cognitive-behavioral treatment for chronic pain and PTSD will report greater maintenance of change, and greater improvements on measures of Pain, Affective Distress, Physical Functioning, and PTSD at 6 months following the completion of treatment than participants in the other three conditions
- As a secondary/exploratory hypothesis, the researchers will examine potential mechanisms of action in treatment.
It is hypothesized that changes in these potential mechanisms will mediate treatment outcome. The proposed study is a four-treatment condition by three-evaluation period (pre-treatment, post-treatment, and 6-month follow-up) repeated measures factorial design with multiple dependent measures. Participants will be 136 patients with co-morbid chronic pain and PTSD receiving care in the VA Boston Healthcare System. Participants in the active treatment conditions will complete 11 weekly outpatient therapy sessions. A clinical psychologist with specialized training in providing both PTSD and chronic pain treatment protocols will conduct therapy in an individual format, 90 minutes in duration. Participants assigned to the TAU condition will not receive treatment beyond that provided by their primary care provider and other healthcare providers. The Cognitive Behavioral Therapy-PAIN condition will follow an adaptation of a manualized treatment protocol used by Kerns and colleagues that emphasizes identifying and modifying maladaptive thoughts and behaviors related to the experience of chronic pain. Participants in the Cognitive Processing Therapy - PTSD condition will receive a manualized treatment protocol that includes several empirically supported techniques including cognitive restructuring, exposure therapy, and skills training. Participants in the Cognitive Behavioral Therapy - Integrated condition will receive an integrated treatment for comorbid pain and PTSD including components of the pain and PTSD treatments described above.
The proposed study will address the specific objectives of the National Pain Management Strategy by helping to assure that clinicians practicing in the VA healthcare system are adequately prepared to assess and manage chronic pain effectively, especially when comorbid with PTSD. Knowledge gained from the proposed study could potentially be utilized by psychologists and other healthcare providers across the VA system nationwide who are currently engaged in Cognitive Behavioral Therapy treatment programs for chronic pain and PTSD. Given that Cognitive Behavioral Therapy has been shown to be efficacious for pain and PTSD, but not for comorbid pain and PTSD, it is imperative that a new integrated treatment be evaluated that has the potential to address the unmet needs of this large population. Thus, this study will have important implications for the delivery of pain management services to veterans and others with chronic pain and PTSD.
- Conditions
- Pain, Posttraumatic Stress Disorder
- Being tested
- Cognitive Behavioral Therapy - Pain, Cognitive Behavioral Therapy-Integrated, Cognitive Processing Therapy - PTSD, Treat as Usual
- Keywords
- Chronic pain, Co-morbid, Intervention, Posttraumatic Stress Disorder, Treatment
- Medical subject headings
- Pain, Stress Disorders, Post-Traumatic, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy - PainBehavioural
Pain treatment
Cognitive Behavioral Therapy-IntegratedBehavioural
Integrated treatment
Cognitive Processing Therapy - PTSDBehavioural
Cognitive processing therapy
Treat as UsualBehavioural
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy - Pain | Experimental | Cognitive Behavioral Therapy targeting chronic pain Receives: Behavioral: Cognitive Behavioral Therapy - Pain |
| Cognitive Behavioral Therapy-Integrated | Experimental | Integrated treatment for comorbid chronic pain and PTSD Receives: Behavioral: Cognitive Behavioral Therapy-Integrated |
| Cognitive Processing Therapy - PTSD | Experimental | Cognitive Processing Therapy for PTSD Receives: Behavioral: Cognitive Processing Therapy - PTSD |
| Treat as Usual | Other | Participants received care for pain and PTSD as usual from their Primary care provider Receives: Behavioral: Treat as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered Assessment of PTSD
This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS has excellent sensitivity (.81) and specificity (.95) (Newman, Kaloupek, \& Keane, 1996). For the purpose of these analyses we examined the total CAPS score. Total CAPS scores can range from 0 to 136. Higher scores represent poorer outcome with a score of greater than 50 indicating that a person meets criteria for PTSD.
Measured: Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startSep 2004
- Primary completionSep 2010
- Study completionSep 2010
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.
- Other trials for 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John Otis, BS BA PhD, Principal investigator, VA Boston Health Care System, Jamaica Plain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127413
- Sponsor's protocol ID
- D3322-R
- Status last verified
- Mar 2015
- First submitted
- 3 Aug 2005
- Last updated
- 27 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Treatment for Chronic Pain and PTSD
- ClinicalTrials.gov ID
- NCT00127413
- Acronym / sponsor ID
- D3322-R
- Conditions
- Pain, Posttraumatic Stress Disorder
- Keywords
- Chronic pain, Co-morbid, Intervention, Posttraumatic Stress Disorder, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2004
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 5 Aug 2005 (estimated)
- Results
- Posted 27 Mar 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 this study is to examine the efficacy of an integrated treatment for Veterans with comorbid chronic pain and posttraumatic stress disorder (PTSD). It is hypothesized that Veterans who receive the integrated treatment will report more positive outcomes than individuals who are assigned to treatment as usual, pain treatment, or PTSD treatment.
Detailed description
Chronic pain and post-traumatic stress disorder frequently co-occur and are associated with a significant level of affective distress, physical disability, and treatment resistance. However, no empirical studies have been conducted investigating the efficacy of a treatment tailored specifically for individuals with comorbid chronic pain and PTSD.
The primary objective of this study is to evaluate the efficacy of a cognitive-behavioral therapy approach for comorbid chronic pain and PTSD. A secondary objective of this study is to examine potential mechanisms of action that might mediate treatment outcome. It is hypothesized that:
1.a) Participants receiving integrated cognitive-behavioral treatment for chronic pain and PTSD will report significantly greater improvements on measures of pain, affective distress, and physical functioning from pre-treatment to post-treatment than participants in the Cognitive Behavioral Treatment for chronic pain, Cognitive Processing Therapy (CPT) for PTSD, or Treatment as Usual (TAU) conditions
1.b) All active treatments will be more effective at promoting improved outcomes than Treatment as Usual
- Participants receiving integrated cognitive-behavioral treatment for chronic pain and PTSD will report decreased symptoms of PTSD from pre-treatment to post-treatment when compared to participants in the other conditions.
- Participants receiving integrated cognitive-behavioral treatment for chronic pain and PTSD will report greater maintenance of change, and greater improvements on measures of Pain, Affective Distress, Physical Functioning, and PTSD at 6 months following the completion of treatment than participants in the other three conditions
- As a secondary/exploratory hypothesis, the researchers will examine potential mechanisms of action in treatment.
It is hypothesized that changes in these potential mechanisms will mediate treatment outcome. The proposed study is a four-treatment condition by three-evaluation period (pre-treatment, post-treatment, and 6-month follow-up) repeated measures factorial design with multiple dependent measures. Participants will be 136 patients with co-morbid chronic pain and PTSD receiving care in the VA Boston Healthcare System. Participants in the active treatment conditions will complete 11 weekly outpatient therapy sessions. A clinical psychologist with specialized training in providing both PTSD and chronic pain treatment protocols will conduct therapy in an individual format, 90 minutes in duration. Participants assigned to the TAU condition will not receive treatment beyond that provided by their primary care provider and other healthcare providers. The Cognitive Behavioral Therapy-PAIN condition will follow an adaptation of a manualized treatment protocol used by Kerns and colleagues that emphasizes identifying and modifying maladaptive thoughts and behaviors related to the experience of chronic pain. Participants in the Cognitive Processing Therapy - PTSD condition will receive a manualized treatment protocol that includes several empirically supported techniques including cognitive restructuring, exposure therapy, and skills training. Participants in the Cognitive Behavioral Therapy - Integrated condition will receive an integrated treatment for comorbid pain and PTSD including components of the pain and PTSD treatments described above.
The proposed study will address the specific objectives of the National Pain Management Strategy by helping to assure that clinicians practicing in the VA healthcare system are adequately prepared to assess and manage chronic pain effectively, especially when comorbid with PTSD. Knowledge gained from the proposed study could potentially be utilized by psychologists and other healthcare providers across the VA system nationwide who are currently engaged in Cognitive Behavioral Therapy treatment programs for chronic pain and PTSD. Given that Cognitive Behavioral Therapy has been shown to be efficacious for pain and PTSD, but not for comorbid pain and PTSD, it is imperative that a new integrated treatment be evaluated that has the potential to address the unmet needs of this large population. Thus, this study will have important implications for the delivery of pain management services to veterans and others with chronic pain and PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy - Pain | Experimental | Behavioral: Cognitive Behavioral Therapy - PainCognitive Behavioral Therapy targeting chronic pain |
| Cognitive Behavioral Therapy-Integrated | Experimental | Behavioral: Cognitive Behavioral Therapy-IntegratedIntegrated treatment for comorbid chronic pain and PTSD |
| Cognitive Processing Therapy - PTSD | Experimental | Behavioral: Cognitive Processing Therapy - PTSDCognitive Processing Therapy for PTSD |
| Treat as Usual | Other | Behavioral: Treat as UsualParticipants received care for pain and PTSD as usual from their Primary care provider |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients will be eligible for participation if they have chronic pain, defined as constant pain of at least six months duration with a neurologic or musculoskeletal etiology. Patients must also meet criteria for PTSD.
- Stability of pain and anxiety medications will be required for two months prior to study entry and during the active treatment and TAU phase.
Key exclusion criteria (4 listed)
- Patients with life threatening or acute physical illness (e.g., cancer).
- Current alcohol or substance abuse or dependence. Veterans who have a history of alcohol or drug dependence but who have not had problematic use in the last six months will be included in the study.
- Current psychosis or suicidal ideation.
- Individuals seeking pain treatment such as surgical interventions will be excluded.
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 Therapy - PainPain treatment | Behavioural | Cognitive Behavioral Therapy - Pain |
| Cognitive Behavioral Therapy-IntegratedIntegrated treatment | Behavioural | Cognitive Behavioral Therapy-Integrated |
| Cognitive Processing Therapy - PTSDCognitive processing therapy | Behavioural | Cognitive Processing Therapy - PTSD |
| Treat as UsualTreatment as usual | Behavioural | Treat as Usual |
Primary outcome
Clinician Administered Assessment of PTSD
Time frame: Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up
This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS has excellent sensitivity (.81) and specificity (.95) (Newman, Kaloupek, \& Keane, 1996). For the purpose of these analyses we examined the total CAPS score. Total CAPS scores can range from 0 to 136. Higher scores represent poorer outcome with a score of greater than 50 indicating that a person meets criteria for PTSD.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this study: Integrated Treatment for Chronic Pain and PTSDLink provided by the sponsor.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
John Otis, BS BA PhD principal investigator
VA Boston Health Care System, Jamaica Plain
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 - Pain, Cognitive Behavioral Therapy-Integrated and Cognitive Processing Therapy - PTSD in people with Pain and Posttraumatic Stress Disorder, 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 2 inclusion and 4 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 27 Mar 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 27 Mar 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?
Clinician Administered Assessment of PTSD (time frame: Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2015.