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

Integrated Treatment for Chronic Pain and PTSD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00127413
Enrollment
42
Registered
2005-08-05
Start date
2004-09-30
Completion date
2010-09-30
Last updated
2015-03-27

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

Conditions

Pain, Posttraumatic Stress Disorder

Keywords

Chronic pain, Co-morbid, Intervention, Posttraumatic Stress Disorder, Treatment

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy - Pain

Pain treatment

BEHAVIORALCognitive Behavioral Therapy-Integrated

Integrated treatment

BEHAVIORALCognitive Processing Therapy - PTSD

Cognitive processing therapy

BEHAVIORALTreat as Usual

Treatment as usual

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinician Administered Assessment of PTSDPretreatment (baseline), Posttreatment (3 months), and 6 month Follow-upThis 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.

Countries

United States

Participant flow

Pre-assignment details

If it was determined during the assessment that a participant did not meet criteria for PTSD or would be excluded based on pre-determined exclusion criteria (e.g., substance use, no pain, psychosis) then the assessment was terminated and additional study related data was not collected. This was done to reduce unnecessary participant burden.

Participants by arm

ArmCount
Cognitive Behavioral Therapy - Pain
Cognitive Behavioral Therapy targeting chronic pain
12
Cognitive Processing Therapy-PTSD
Cognitive processing therapy for PTSD
10
Cognitive Behavioral Therapy-Integrated
Integrated treatment for comorbid chronic pain and PTSD
13
Treat as Usual
Participants received care for pain and PTSD as usual from their primary care provider.
7
Total42

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up6482

Baseline characteristics

CharacteristicCognitive Behavioral Therapy - PainTotalTreat as UsualCognitive Behavioral Therapy-IntegratedCognitive Processing Therapy-PTSD
Age, Continuous54.13 years
STANDARD_DEVIATION 5.6
52.80 years
STANDARD_DEVIATION 6.23
52.40 years
STANDARD_DEVIATION 4.67
54.18 years
STANDARD_DEVIATION 7.82
49.20 years
STANDARD_DEVIATION 5.27
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
5 Participants13 Participants2 Participants3 Participants3 Participants
Race (NIH/OMB)
More than one race
1 Participants3 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
6 Participants25 Participants5 Participants8 Participants6 Participants
Region of Enrollment
United States
12 participants42 participants7 participants13 participants10 participants
Sex: Female, Male
Female
1 Participants8 Participants1 Participants3 Participants3 Participants
Sex: Female, Male
Male
11 Participants34 Participants6 Participants10 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 120 / 100 / 130 / 7
serious
Total, serious adverse events
0 / 120 / 100 / 130 / 7

Outcome results

Primary

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.

Time frame: Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral Therapy - PainClinician Administered Assessment of PTSDPretreatment80.67 units on a scaleStandard Deviation 16.16
Cognitive Behavioral Therapy - PainClinician Administered Assessment of PTSD6 month Follow-up79.50 units on a scaleStandard Deviation 12.94
Cognitive Behavioral Therapy - PainClinician Administered Assessment of PTSDPosttreatment75.5 units on a scaleStandard Deviation 25.65
Cognitive Processing Therapy - PTSDClinician Administered Assessment of PTSDPretreatment70.83 units on a scaleStandard Deviation 14.13
Cognitive Processing Therapy - PTSDClinician Administered Assessment of PTSD6 month Follow-up52.17 units on a scaleStandard Deviation 32.25
Cognitive Processing Therapy - PTSDClinician Administered Assessment of PTSDPosttreatment50.50 units on a scaleStandard Deviation 22.06
Cognitive Behavioral Therapy - IntegratedClinician Administered Assessment of PTSDPosttreatment62.80 units on a scaleStandard Deviation 21.27
Cognitive Behavioral Therapy - IntegratedClinician Administered Assessment of PTSDPretreatment77.60 units on a scaleStandard Deviation 21.98
Cognitive Behavioral Therapy - IntegratedClinician Administered Assessment of PTSD6 month Follow-up78.40 units on a scaleStandard Deviation 18.2
Treat as UsualClinician Administered Assessment of PTSDPretreatment74.73 units on a scaleStandard Deviation 15.96
Treat as UsualClinician Administered Assessment of PTSD6 month Follow-up48.40 units on a scaleStandard Deviation 24.04
Treat as UsualClinician Administered Assessment of PTSDPosttreatment47.60 units on a scaleStandard Deviation 32.4

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