Trial Outcomes & Findings for Integrated Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD) (NCT NCT00127413)

Last Updated: 2015-03-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

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

Results posted on

2015-03-27

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Cognitive Behavioral Therapy - Pain Cognitive Behavioral Therapy targeting chronic pain	Cognitive Processing Therapy - PTSD Cognitive processing therapy for PTSD	Cognitive Behavioral Therapy - Integrated Integrated treatment for comorbid chronic pain and PTSD	Treat as Usual Participants received care for pain and PTSD as usual from their primary care provider.
Overall Study STARTED	12	10	13	7
Overall Study COMPLETED	6	6	5	5
Overall Study NOT COMPLETED	6	4	8	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cognitive Behavioral Therapy - Pain Cognitive Behavioral Therapy targeting chronic pain	Cognitive Processing Therapy - PTSD Cognitive processing therapy for PTSD	Cognitive Behavioral Therapy - Integrated Integrated treatment for comorbid chronic pain and PTSD	Treat as Usual Participants received care for pain and PTSD as usual from their primary care provider.
Overall Study Lost to Follow-up	6	4	8	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Behavioral Therapy - Pain n=12 Participants Cognitive Behavioral Therapy targeting chronic pain	Cognitive Processing Therapy-PTSD n=10 Participants Cognitive processing therapy for PTSD	Cognitive Behavioral Therapy-Integrated n=13 Participants Integrated treatment for comorbid chronic pain and PTSD	Treat as Usual n=7 Participants Participants received care for pain and PTSD as usual from their primary care provider.	Total n=42 Participants Total of all reporting groups
Age, Continuous	54.13 years STANDARD_DEVIATION 5.6 • n=5 Participants	49.20 years STANDARD_DEVIATION 5.27 • n=7 Participants	54.18 years STANDARD_DEVIATION 7.82 • n=5 Participants	52.40 years STANDARD_DEVIATION 4.67 • n=4 Participants	52.80 years STANDARD_DEVIATION 6.23 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	6 Participants n=4 Participants	34 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	5 Participants n=4 Participants	25 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	12 participants n=5 Participants	10 participants n=7 Participants	13 participants n=5 Participants	7 participants n=4 Participants	42 participants n=21 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy - Pain n=6 Participants Cognitive Behavioral Therapy targeting chronic pain	Cognitive Processing Therapy - PTSD n=6 Participants Cognitive processing therapy for PTSD	Cognitive Behavioral Therapy - Integrated n=5 Participants Cognitive Behavioral Therapy - Integrated treatment for pain and PTSD	Treat as Usual n=5 Participants Participants received care for pain and PTSD as usual from their primary care provider
Clinician Administered Assessment of PTSD Pretreatment	80.67 units on a scale Standard Deviation 16.16	70.83 units on a scale Standard Deviation 14.13	77.60 units on a scale Standard Deviation 21.98	74.73 units on a scale Standard Deviation 15.96
Clinician Administered Assessment of PTSD Posttreatment	75.5 units on a scale Standard Deviation 25.65	50.50 units on a scale Standard Deviation 22.06	62.80 units on a scale Standard Deviation 21.27	47.60 units on a scale Standard Deviation 32.40
Clinician Administered Assessment of PTSD 6 month Follow-up	79.50 units on a scale Standard Deviation 12.94	52.17 units on a scale Standard Deviation 32.25	78.40 units on a scale Standard Deviation 18.2	48.40 units on a scale Standard Deviation 24.04

Adverse Events

Cognitive Behavioral Therapy - Pain

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive Processing Therapy - PTSD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive Behavioral Therapy-Integrated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treat 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 D. Otis

VA Boston Healthcare System

Phone: 8573645740

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place