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A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00984698
First Posted: September 25, 2009
Last Update Posted: March 31, 2014
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.
Collaborators:
United States Department of Defense
Southern Arizona VA Health Care System
Information provided by (Responsible Party):
Tricia Haynes, University of Arizona
Results First Submitted: January 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Posttraumatic Stress Disorder
Depression
Insomnia Disorder
Interventions: Behavioral: Cognitive Behavioral Social Rhythm Group Therapy
Behavioral: Present Centered Group 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
Veterans were recruited from the Southern Arizona VA Health Care System, Mental Health Clinic, September 2009 to July 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
115 enrolled, 50 eligible, 7 withdrew prior to randomization (3 time commitment, 2 lost contact, 1 changed mind/unknown, 1 travel distance)

Reporting Groups
  Description
Cognitive Behavioral Social Rhythm Group Therapy CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
Present Centered Group Therapy PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.

Participant Flow:   Overall Study
    Cognitive Behavioral Social Rhythm Group Therapy   Present Centered Group Therapy
STARTED   21   22 
COMPLETED   18   14 
NOT COMPLETED   3   8 



  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
Cognitive Behavioral Social Rhythm Group Therapy CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
Present Centered Group Therapy PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
Total Total of all reporting groups

Baseline Measures
   Cognitive Behavioral Social Rhythm Group Therapy   Present Centered Group Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   22   43 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   21   22   43 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.24  (13.99)   51.46  (12.60)   48.42  (13.51) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   21   22   43 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   6   4   10 
Not Hispanic or Latino   15   16   31 
Unknown or Not Reported   0   2   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Depression   [ Time Frame: post-treatment, at 12 weeks ]

2.  Secondary:   PTSD   [ Time Frame: post-treatment, at 12 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
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  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: Dr. Patricia Haynes, Assistant Professor
Organization: University of Arizona
phone: 5206261855
e-mail: thaynes@email.arizona.edu



Responsible Party: Tricia Haynes, University of Arizona
ClinicalTrials.gov Identifier: NCT00984698     History of Changes
Other Study ID Numbers: W81XWH-08-2-0121
First Submitted: September 24, 2009
First Posted: September 25, 2009
Results First Submitted: January 6, 2014
Results First Posted: March 31, 2014
Last Update Posted: March 31, 2014