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

This study has been completed.
Sponsor:
Collaborators:
Southern Arizona VA Health Care System
Information provided by (Responsible Party):
Tricia Haynes, University of Arizona
ClinicalTrials.gov Identifier:
NCT00984698
First received: September 24, 2009
Last updated: February 14, 2014
Last verified: February 2014
Results First Received: January 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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  
Number of Participants  
[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


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


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Patricia Haynes, Assistant Professor
Organization: University of Arizona
phone: 5206261855
e-mail: thaynes@email.arizona.edu


No publications provided


Responsible Party: Tricia Haynes, University of Arizona
ClinicalTrials.gov Identifier: NCT00984698     History of Changes
Other Study ID Numbers: W81XWH-08-2-0121
Study First Received: September 24, 2009
Results First Received: January 6, 2014
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board