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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01120067
• Collaborator: (none)
• Enrollment: 23
• Locations: 2
• Arms: 2
• Actual Duration (Months): 76.9
• Patients Per Site: 11.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post-Traumatic	Behavioral: Intensive Treatment; Behavioral: Treatment as Usual	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intensive Treatment of Chronic Pain and PTSD for OEF/OIF Veterans
• Actual Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Dec 29, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intensive Treatment Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain	Behavioral: 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.
Experimental: Treatment as Usual Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD	Behavioral: Treatment as Usual; Treatment as Usual.

Outcome Measures

Primary Outcome Measures

1. McGill Pain Questionnaire [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut	United States	06516
2	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts	United States	02130

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: John Otis, BS BA PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01120067
• Other Study ID Numbers: D6281-I
• First Posted: May 10, 2010
• Last Update Posted: Apr 12, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by VA Office of Research and Development: Psychology; Pain; Veterans; Stress Disorders, Post-Traumatic
• Additional relevant MeSH terms: Chronic Pain; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Arm/Group Title	Intensive Treatment	Treatment as Usual
Arm/Group Description	Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain 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.	Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD Treatment as Usual: Treatment as Usual.
Period Title: Overall Study
STARTED	12	11
COMPLETED	7	10
NOT COMPLETED	5	1

Baseline Characteristics

Arm/Group Title	Intensive Treatment	Treatment as Usual	Total
Arm/Group Description	Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain 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.	Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD Treatment as Usual: Treatment as Usual.	Total of all reporting groups
Overall Participants	12	11	23
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.75 (10.39)	52.09 (10.64)	49.79 (10.274)
Sex: Female, Male (Count of Participants)
Female	0 0%	2 18.2%	2 8.7%
Male	12 100%	9 81.8%	21 91.3%
Race/Ethnicity, Customized (Count of Participants)
White/Caucasian	9 75%	9 81.8%	18 78.3%
African American	2 16.7%	2 18.2%	4 17.4%
Hispanic	1 8.3%	0 0%	1 4.3%
Region of Enrollment (Count of Participants)
United States	12 100%	11 100%	23 100%

Outcome Measures

1. Primary Outcome

Title	McGill Pain Questionnaire
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intensive Treatment	Treatment as Usual
Arm/Group Description	Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain 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.	Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD Treatment as Usual: Treatment as Usual.
Measure Participants	12	11
Mean (Standard Deviation) [units on a scale]	31.91 (13.55)	30.83 (13.61)

Adverse Events

Arm/Group Title	Intensive Treatment		Treatment as Usual
Arm/Group Description	Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain 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.		Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD Treatment as Usual: Treatment as Usual.
All Cause Mortality
	Intensive Treatment		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intensive Treatment		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Intensive Treatment		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)

Limitations/Caveats

Small N due to challenges associated with recruitment.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.