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Integrated Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)

Primary Purpose

Pain, Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy - Pain
Cognitive Behavioral Therapy-Integrated
Cognitive Processing Therapy - PTSD
Treat as Usual
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Chronic pain, Co-morbid, Intervention, Posttraumatic Stress Disorder, Treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • VA Boston Health Care System, Jamaica Plain

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Cognitive Behavioral Therapy - Pain

Cognitive Behavioral Therapy-Integrated

Cognitive Processing Therapy - PTSD

Treat as Usual

Arm Description

Cognitive Behavioral Therapy targeting chronic pain

Integrated treatment for comorbid chronic pain and PTSD

Cognitive Processing Therapy for PTSD

Participants received care for pain and PTSD as usual from their Primary care provider

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2005
Last Updated
March 23, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00127413
Brief Title
Integrated Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)
Official Title
Integrated Treatment for Chronic Pain and PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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 2) 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. 3) 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 4) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Posttraumatic Stress Disorder
Keywords
Chronic pain, Co-morbid, Intervention, Posttraumatic Stress Disorder, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy - Pain
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy targeting chronic pain
Arm Title
Cognitive Behavioral Therapy-Integrated
Arm Type
Experimental
Arm Description
Integrated treatment for comorbid chronic pain and PTSD
Arm Title
Cognitive Processing Therapy - PTSD
Arm Type
Experimental
Arm Description
Cognitive Processing Therapy for PTSD
Arm Title
Treat as Usual
Arm Type
Other
Arm Description
Participants received care for pain and PTSD as usual from their Primary care provider
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy - Pain
Intervention Description
Pain treatment
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy-Integrated
Intervention Description
Integrated treatment
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy - PTSD
Intervention Description
Cognitive processing therapy
Intervention Type
Behavioral
Intervention Name(s)
Treat as Usual
Intervention Description
Treatment as usual
Primary Outcome Measure Information:
Title
Clinician Administered Assessment of PTSD
Description
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.
Time Frame
Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Otis, BS BA PhD
Organizational Affiliation
VA Boston Health Care System, Jamaica Plain
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Health Care System, Jamaica Plain
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ptsd.va.gov
Description
Click here for more information about this study: Integrated Treatment for Chronic Pain and PTSD

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Integrated Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)

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