NCT01120067

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 10, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 16, 2016

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2016

Completed
Last Updated

April 12, 2017

Status Verified

March 1, 2017

Enrollment Period

5 years

First QC Date

April 30, 2010

Results QC Date

October 24, 2016

Last Update Submit

March 13, 2017

Conditions

Stress Disorders, Post-Traumatic

Keywords

PsychologyPainVeteransStress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

  • McGill Pain Questionnaire

    McGill Pain Questionnaire (MPQ; Melzack, 1975): is a self-report questionnaire consisting of 102 words separated into three major classes; the sensory, affective, and evaluative aspects of pain. Respondents are asked to circle the word that best describes their pain. The stability, reliability, and validity of the MPQ have been established (Reading, Everitt, \& Sledmere, 1982). The MPQ total score ranges from 0 to 78 with higher values indicating more significant pain.

    6 months

Study Arms (2)

Intensive Treatment

EXPERIMENTAL

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

Behavioral: Intensive Treatment

Treatment as Usual

EXPERIMENTAL

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

Behavioral: Treatment as Usual

Interventions

Intensive TreatmentBEHAVIORAL

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.

Intensive Treatment
Treatment as UsualBEHAVIORAL

Treatment as Usual.

Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

West Haven, Connecticut, 06516, United States

Location

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

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

  • 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.

    PMID: 22781019RESULT

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticPain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Small N due to challenges associated with recruitment.

Results Point of Contact

Title
John Otis
Organization
VA Boston Healthcare System
john.otis@va.gov
857-364-5740

Study Officials

  • John Otis, BS BA PhD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2010

First Posted

May 10, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2015

Study Completion

December 29, 2016

Last Updated

April 12, 2017

Results First Posted

December 16, 2016

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)