MedDataX Logo

Trial Outcomes & Findings for Intensive Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD) (NCT NCT01120067)

NCT ID: NCT01120067

Last Updated: 2017-04-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

6 months

Results posted on

2017-04-12

Participant Flow

Participant milestones

Participant milestones
Measure
Intensive Treatment
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
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.
Overall Study
STARTED
12
11
Overall Study
COMPLETED
7
10
Overall Study
NOT COMPLETED
5
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Intensive Treatment
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
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.
Overall Study
Lost to Follow-up
3
1
Overall Study
fail to engage >3 sessions
2
0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intensive Treatment
n=12 Participants
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
n=11 Participants
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
n=23 Participants
Total of all reporting groups
Age, Continuous
47.75 years
STANDARD_DEVIATION 10.39 • n=5 Participants
52.09 years
STANDARD_DEVIATION 10.64 • n=7 Participants
49.79 years
STANDARD_DEVIATION 10.274 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
9 Participants
n=7 Participants
21 Participants
n=5 Participants
Race/Ethnicity, Customized
White/Caucasian
9 Participants
n=5 Participants
9 Participants
n=7 Participants
18 Participants
n=5 Participants
Race/Ethnicity, Customized
African American
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
United States
12 Participants
n=5 Participants
11 Participants
n=7 Participants
23 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intensive Treatment
n=12 Participants
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
n=11 Participants
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.
McGill Pain Questionnaire
31.91 units on a scale
Standard Deviation 13.55
30.83 units on a scale
Standard Deviation 13.61

Adverse Events

Intensive Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Otis

VA Boston Healthcare System

Phone: 857-364-5740

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place