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

NCT ID: NCT01120067

Last Updated: 2017-04-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-01

Study Completion Date

2016-12-29

Brief Summary

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This study is investigating the efficacy of an intensive (3 week) integrated treatment for Veterans with both pain and PTSD.

Detailed Description

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Objectives:

The primary objective of this study is to evaluate the efficacy of an intensive integrated treatment for Veterans with comorbid chronic pain and posttraumatic stress disorder (PTSD). A secondary objective is to examine potential mechanisms of action that might account for improvements in pain or PTSD. Third, exploratory analyses will be conducted to assess the relationship between participation in treatment and cognitive functioning. It is hypothesized that 1) participants receiving the intensive treatment (PT) will report significantly greater decreases in symptoms of pain and PTSD from pre-treatment to post-treatment when compared to participants randomized to a standard care (SC) condition, and 2) participants receiving PT will show greater maintenance of change on measures of pain and PTSD at 3 months following the completion of treatment when compared to participants randomized to the SC condition.

Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensive Treatment

Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain

Group Type EXPERIMENTAL

Intensive Treatment

Intervention Type BEHAVIORAL

Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration.

Treatment as Usual

Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD

Group Type EXPERIMENTAL

Treatment as Usual

Intervention Type BEHAVIORAL

Treatment as Usual.

Interventions

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Intensive Treatment

Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration.

Intervention Type BEHAVIORAL

Treatment as Usual

Treatment as Usual.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients will be eligible to participate if they have constant pain of at least three months duration with a neurologic or musculoskeletal etiology.
* Patients must also meet diagnostic criteria for PTSD.

Exclusion Criteria

* Patients with life threatening or acute physical illness, current alcohol or substance abuse, current psychosis or suicidal ideation, and individuals seeking pain treatment such as surgical interventions will be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Otis, BS BA PhD

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

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VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States

Site Status

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Tsai J, Whealin JM, Scott JC, Harpaz-Rotem I, Pietrzak RH. Examining the relation between combat-related concussion, a novel 5-factor model of posttraumatic stress symptoms, and health-related quality of life in Iraq and Afghanistan veterans. J Clin Psychiatry. 2012 Aug;73(8):1110-8. doi: 10.4088/JCP.11m07587. Epub 2012 Jun 26.

Reference Type RESULT
PMID: 22781019 (View on PubMed)

Other Identifiers

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D6281-I

Identifier Type: -

Identifier Source: org_study_id

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