Couple-Based Treatment for Alcohol Use Disorders and Post-Traumatic Stress Disorder (CTAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00946322
First received: July 23, 2009
Last updated: December 8, 2015
Last verified: December 2015
Results First Received: December 8, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Alcohol-related Disorders
Post-traumatic Stress Disorder
Intervention: Behavioral: Couple-Based Treatment for Alcohol Use Disorders and PTSD

  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
1 couple was excluded due to discovery that they did not meet eligibility requirements

Reporting Groups
  Description
Arm 1: CTAP Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.

Participant Flow for 2 periods

Period 1:   Pre-treatment
    Arm 1: CTAP  
STARTED     12  
COMPLETED     11  
NOT COMPLETED     1  
participant failure to follow up                 1  

Period 2:   Post-treatment
    Arm 1: CTAP  
STARTED     11  
COMPLETED     9  
NOT COMPLETED     2  
participant failure to follow up                 2  



  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
Arm 1: CTAP Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.

Baseline Measures
    Arm 1: CTAP  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean (Standard Deviation)
  42.22  (16.14)  
Gender  
[units: participants]
 
Female     0  
Male     12  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     7  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures
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1.  Primary:   Clinician-administered PTSD Scale (CAPS)   [ Time Frame: Pre- to post-treatment (~20 weeks) ]

2.  Primary:   Percentage Days of Heavy Drinking   [ Time Frame: Pre- to post-treatment (~20 weeks) ]

3.  Primary:   Patient-reported PTSD Checklist   [ Time Frame: Pre- to post-treatment (~20 weeks) ]

4.  Primary:   Partner-reported PTSD Checklist   [ Time Frame: Pre- to post-treatment (~20 weeks) ]

5.  Secondary:   Patient-reported Beck Depression Inventory - II (BDI-II)   [ Time Frame: Pre- to post-treatment ]

6.  Secondary:   Patient-reported Dyadic Adjustment Scale   [ Time Frame: Pre- to post-treatment (~20 weeks) ]

7.  Secondary:   Partner-reported Beck Depression Inventory - II   [ Time Frame: Pre- to post-treatment (~20 weeks) ]

8.  Secondary:   Partner-reported Dyadic Adjustment Scale   [ Time Frame: Pre- to post-treatment (~20 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
Study was an initial open-trial pilot study. A causal relationship cannot be determined between study interventions and outcomes due to lack of a comparison condition.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeremiah A. Schumm, PhD, Associate Director
Organization: Trauma Recovery Center, Cincinnati VA Medical Center
phone: 859-572-6717
e-mail: Jeremiah.Schumm@va.gov


No publications provided


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00946322     History of Changes
Other Study ID Numbers: CDA-2-019-09S
Study First Received: July 23, 2009
Results First Received: December 8, 2015
Last Updated: December 8, 2015
Health Authority: United States: Federal Government