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Telemedicine and Anger Management Groups With PTSD Veterans in the Hawaiian Islands

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00122109
First Posted: July 21, 2005
Last Update Posted: April 28, 2015
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: August 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Posttraumatic Stress Disorder
Intervention: Behavioral: 12 sessions Anger Management 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
Recruitment took place between 2005-2008. Participants were recruited across three VA Pacific Island Healthcare System clinical sites and Vet Centers across the Hawaiian Islands, Maui, and Oahu. Attempts were made to recruit 16 participants for each of 9 cohorts with 10 participants randomized into each conditon (VTC vs NP) within a cohort.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 125 veterans who entered treatment, 112 attended at least 9 of 12 treatment sessions and were included in our completer sample (NP = 57 and VTC = 55).

Reporting Groups
  Description
Videoteleconferencing AMT

The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.

Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality.

Face to Face AMT

The control arm is the group condition that received the CPT treatment intervention face-to-face traditional modality as compared to the experimental condition which is the via a videoteleconferencing modality .

Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality.


Participant Flow:   Overall Study
    Videoteleconferencing AMT   Face to Face AMT
STARTED   61 [1]   64 [1] 
COMPLETED   55   57 
NOT COMPLETED   6   7 
Did not meet criteria                6                7 
[1] ITT



  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
Videoteleconferencing AMT

The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.

Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality.

Face to Face AMT

The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferncing modality.

Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality.

Total Total of all reporting groups

Baseline Measures
   Videoteleconferencing AMT   Face to Face AMT   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   64   125 
Age 
[Units: Years]
Mean (Full Range)
 54.8 
 (24 to 80) 
 54.6 
 (22 to 75) 
 54.7 
 (22 to 80) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   61   64   125 
Region of Enrollment 
[Units: Participants]
     
United States   61   64   125 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   State-Trait Anger Inventory (STAXI-2) Anger Expression Index   [ Time Frame: Baseline ]

2.  Primary:   State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale   [ Time Frame: Post-treatment (2 weeks following last treatment session) ]

3.  Primary:   State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale   [ Time Frame: 3-month Follow Up ]

4.  Primary:   State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale   [ Time Frame: 6-month Follow Up ]

5.  Primary:   Novaco Anger Scale (NAS)   [ Time Frame: Baseline ]

6.  Primary:   Novaco Anger Scale (NAS)   [ Time Frame: Post-treatment (2 weeks following last treatment session) ]

7.  Primary:   Novaco Anger Scale (NAS)   [ Time Frame: 3-Month Follow Up ]

8.  Primary:   Novaco Anger Scale (NAS)   [ Time Frame: 6-Month Follow Up ]

9.  Secondary:   PTSD Checklist-military Version (PCL-M)   [ Time Frame: Baseline ]

10.  Secondary:   PTSD Checklist-military Version (PCL-M)   [ Time Frame: Post-treatment (2 weeks following last treatment session) ]


  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
We conservatively excluced participants with acute safety concerns (homicidal or suicidal) and current substance dependence. However other literature suugests that both issues can be safely addressed via telemedicine.


  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: Leslie A. Morland, PsyD, Principal Investigator
Organization: VA Pacific Islands Healthcare System
phone: (808) 566-1934
e-mail: leslie.morland@va.gov


Publications of Results:
Gros DF, Gros K, Acierno R, Frueh BC, Moreland L. Relation between treatment satisfaction and treatment outcome in veterans with posttraumatic stress disorder. Journal of psychopathology and behavioral assessment. 2013 Jun 28; 35(4):522-30.
Macdonald A, Greene CJ, Torres JG, Frueh BC, Morland LA. Concordance between clinician-assessed and self-report ratings of posttraumatic stress disorder across three ethnoracial groups. Psychological trauma : theory, research, practice and policy. 2012 Jan 1; 24:doi: 10.1037/a0027313.


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00122109     History of Changes
Other Study ID Numbers: TEL 03-080
First Submitted: July 18, 2005
First Posted: July 21, 2005
Results First Submitted: August 22, 2014
Results First Posted: October 16, 2014
Last Update Posted: April 28, 2015