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Integrated vs Sequential Treatment for PTSD and Addiction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01211106
First received: September 27, 2010
Last updated: January 17, 2017
Last verified: January 2017
Results First Received: January 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: PTSD
Substance Addiction
Interventions: Behavioral: Prolonged Exposure
Behavioral: Motivational Enhancement Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Integrated Care   Sequential Treatment
STARTED   95   88 
COMPLETED   82   77 
NOT COMPLETED   13   11 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Integrated Care   Sequential Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 95   88   183 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.1  (13.1)   43.8  (13.0)   44.1  (13.0) 
Gender 
[Units: Participants]
Count of Participants
     
Female      5   5.3%      9  10.2%      14   7.7% 
Male      90  94.7%      79  89.8%      169  92.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   1.1%      1   1.1%      2   1.1% 
Asian      1   1.1%      0   0.0%      1   0.5% 
Native Hawaiian or Other Pacific Islander      1   1.1%      1   1.1%      2   1.1% 
Black or African American      49  51.6%      42  47.7%      91  49.7% 
White      37  38.9%      38  43.2%      75  41.0% 
More than one race      3   3.2%      3   3.4%      6   3.3% 
Unknown or Not Reported      3   3.2%      3   3.4%      6   3.3% 
Region of Enrollment 
[Units: Participants]
     
United States   95   88   183 
PTSD Checklist score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 62.5  (11.3)   63.6  (10.3)   63.0  (10.9) 
[1] PTSD Checklist score 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.
Percent days of heavy drinking 
[Units: Percent days heavy drinking]
Mean (Standard Deviation)
 51.7  (29.5)   56.0  (29.6)   53.8  (29.6) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   PTSD Symptoms   [ Time Frame: 16 weeks ]

2.  Primary:   Drinking Outcome   [ Time Frame: 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Both arms of the study were active treatments. There was no control conditions.


  More Information
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Certain Agreements:  
Principal Investigators are NOT 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.


Results Point of Contact:  
Name/Title: David Oslin, MD
Organization: Cpl Micheal J Crescenz VA Medical Center
phone: 215-823-5894
e-mail: dave.oslin@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01211106     History of Changes
Other Study ID Numbers: ZDA1-03-W10
Study First Received: September 27, 2010
Results First Received: January 17, 2017
Last Updated: January 17, 2017