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IOK Treatment Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605799
First Posted: May 25, 2012
Last Update Posted: February 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: November 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Posttraumatic Stress Disorder
Interventions: Behavioral: IOK Killing Treatment
Behavioral: Wait list control group

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
IOK Treatment

Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.

IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.

Wait List Control Group

Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.

IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.

Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.


Participant Flow:   Overall Study
    IOK Treatment   Wait List Control Group
STARTED   17   16 
COMPLETED   15   15 
NOT COMPLETED   2   1 
Withdrawal by Subject                2                1 



  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.
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Reporting Groups
  Description
IOK Treatment

Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.

IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.

Wait List Control Group

Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.

IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.

Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.

Total Total of all reporting groups

Baseline Measures
   IOK Treatment   Wait List Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.4  (12.8)   60.5  (14.3)   59.9  (13.4) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   15   15   30 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   1   0   1 
Black   3   3   6 
Caucasian   7   11   18 
Latino   1   0   1 
Multiracial   3   1   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in PTSD Symptoms as Measured by the PCL   [ Time Frame: PTSD symptoms will be assessed at Baseline or the first study visit and the end of treatment (Week 7) ]

2.  Secondary:   Change in Psychological Symptoms as Measured by the Brief Symptom Inventory (BSI-53)   [ Time Frame: The BSI will be administered at Baseline or the first study visit and the end of treatment (Week 7) ]


  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
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  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: Dr. Shira Maguen
Organization: San Francisco VA Medical Center
phone: 415-221-4810 ext 22511
e-mail: shira.maguen@va.gov


Publications of Results:
Maguen S, Burkman K. Combat-Related Killing: Expanding Evidence-Based Treatments for PTSD. Cognitive and behavioral practice. 2013 Nov 1; 20(4):476-479.


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01605799     History of Changes
Other Study ID Numbers: RRP 12-237
First Submitted: May 18, 2012
First Posted: May 25, 2012
Results First Submitted: November 13, 2015
Results First Posted: December 17, 2015
Last Update Posted: February 23, 2016