Trial Outcomes & Findings for Integrated vs Sequential Treatment for PTSD and Addiction (NCT NCT01211106)

NCT ID: NCT01211106

Last Updated: 2017-03-09

Results Overview

PTSD checklist (PCL), the PCL version used with the civilian PCL. The PCL is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, circling their responses. Responses range from 1 Not at All - 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 183 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2017-03-09

Participant Flow

Participant milestones

Measure	Integrated Care Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.	Sequential Treatment Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
Overall Study STARTED	95	88
Overall Study COMPLETED	82	77
Overall Study NOT COMPLETED	13	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Integrated vs Sequential Treatment for PTSD and Addiction

Baseline characteristics by cohort

Measure	Integrated Care n=95 Participants Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.	Sequential Treatment n=88 Participants Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.	Total n=183 Participants Total of all reporting groups
Age, Continuous	44.1 years STANDARD_DEVIATION 13.1 • n=5 Participants	43.8 years STANDARD_DEVIATION 13.0 • n=7 Participants	44.1 years STANDARD_DEVIATION 13.0 • n=5 Participants
Gender Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Gender Male	90 Participants n=5 Participants	79 Participants n=7 Participants	169 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	49 Participants n=5 Participants	42 Participants n=7 Participants	91 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	95 participants n=5 Participants	88 participants n=7 Participants	183 participants n=5 Participants
PTSD Checklist score	62.5 units on a scale STANDARD_DEVIATION 11.3 • n=5 Participants	63.6 units on a scale STANDARD_DEVIATION 10.3 • n=7 Participants	63.0 units on a scale STANDARD_DEVIATION 10.9 • n=5 Participants
Percent days of heavy drinking	51.7 percent days heavy drinking STANDARD_DEVIATION 29.5 • n=5 Participants	56.0 percent days heavy drinking STANDARD_DEVIATION 29.6 • n=7 Participants	53.8 percent days heavy drinking STANDARD_DEVIATION 29.6 • n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

PTSD checklist (PCL), the PCL version used with the civilian PCL. The PCL is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, circling their responses. Responses range from 1 Not at All - 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms.

Outcome measures

Measure	Arm 1: Integrated Conditions n=82 Participants Motivational enhancement therapy combined with Prolonged Exposure therapy.	Arm 2 Sequential Therapy n=77 Participants MET followed by Prolonged Exposure
PTSD Symptoms	55.5 units on a scale Standard Deviation 17.6	54.1 units on a scale Standard Deviation 17.9

PRIMARY outcome

Timeframe: 16 weeks

Population: The number of subjects available for this measure are greater than the PTSD outcome as drinking outcomes can be obtained at anytime and thus some participants provided data at the post study evaluation.

Percent days of heavy drinking during the sixteen weeks. The percentage of days in which heavy drinking occurred ranges from 0 - 100% with lower days associated with better outcomes.

Outcome measures

Measure	Arm 1: Integrated Conditions n=83 Participants Motivational enhancement therapy combined with Prolonged Exposure therapy.	Arm 2 Sequential Therapy n=79 Participants MET followed by Prolonged Exposure
Drinking Outcome	48.8 percent days ofheavy drinking Standard Deviation 38.4	40.6 percent days ofheavy drinking Standard Deviation 34.6

Adverse Events

Integrated Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sequential Treatment

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

David Oslin, MD

Cpl Micheal J Crescenz VA Medical Center

Phone: 215-823-5894

Email: dave.oslin@va.gov

Results disclosure agreements

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