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

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ClinicalTrials.gov Identifier: NCT00122109
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : October 16, 2014
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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.
Enrollment 125

Recruitment Details 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 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).
Arm/Group Title Videoteleconferencing AMT Face to Face AMT
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 61 [1] 64 [1]
Completed 55 57
Not Completed 6 7
Reason Not Completed
Did not meet criteria             6             7
[1]
ITT
Arm/Group Title Videoteleconferencing AMT Face to Face AMT Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 61 64 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 61 participants 64 participants 125 participants
54.8
(24 to 80)
54.6
(22 to 75)
54.7
(22 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 64 participants 125 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
61
 100.0%
64
 100.0%
125
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 61 participants 64 participants 125 participants
61 64 125
1.Primary Outcome
Title State-Trait Anger Inventory (STAXI-2) Anger Expression Index
Hide Description Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Videoteleconferencing AMT Face to Face AMT
Hide Arm/Group Description:
The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
Overall Number of Participants Analyzed 61 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
56.7  (12.0) 55.0  (10.3)
2.Primary Outcome
Title State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
Hide Description Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.
Time Frame Post-treatment (2 weeks following last treatment session)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Videoteleconferencing AMT Face to Face AMT
Hide Arm/Group Description:

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.

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

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

Overall Number of Participants Analyzed 61 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
42.4  (16.2) 46.6  (12.2)
3.Primary Outcome
Title State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
Hide Description Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.
Time Frame 3-month Follow Up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Videoteleconferencing AMT Face to Face AMT
Hide Arm/Group Description:
The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
Overall Number of Participants Analyzed 61 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
41.8  (15.3) 47.0  (13.4)
4.Primary Outcome
Title State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
Hide Description Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.
Time Frame 6-month Follow Up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Videoteleconferencing AMT Face to Face AMT
Hide Arm/Group Description:
The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
Overall Number of Participants Analyzed 61 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
42.0  (15.6) 46.6  (15.3)
5.Primary Outcome
Title Novaco Anger Scale (NAS)
Hide Description Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Videoteleconferencing AMT Face to Face AMT
Hide Arm/Group Description:
The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
Overall Number of Participants Analyzed 61 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
109.3  (16.1) 109.8  (14.0)
6.Primary Outcome
Title Novaco Anger Scale (NAS)
Hide Description Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.
Time Frame Post-treatment (2 weeks following last treatment session)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Videoteleconferencing AMT Face to Face AMT
Hide Arm/Group Description:

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.

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 videoteleconferencing modality.

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

Overall Number of Participants Analyzed 61 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
94.2  (19.1) 99.2  (17.1)
7.Primary Outcome
Title Novaco Anger Scale (NAS)
Hide Description Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.
Time Frame 3-Month Follow Up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Videoteleconferencing AMT Face to Face AMT
Hide Arm/Group Description:
The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
Overall Number of Participants Analyzed 61 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
96.4  (18.4) 105.2  (19.2)
8.Primary Outcome
Title Novaco Anger Scale (NAS)
Hide Description Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.
Time Frame 6-Month Follow Up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Videoteleconferencing AMT Face to Face AMT
Hide Arm/Group Description:
The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
Overall Number of Participants Analyzed 61 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
97.7  (20.2) 101.0  (22.5)
9.Secondary Outcome
Title PTSD Checklist-military Version (PCL-M)
Hide Description Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Videoteleconferencing AMT Face to Face AMT
Hide Arm/Group Description:
The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
Overall Number of Participants Analyzed 61 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
64.5  (11.6) 65.8  (10.8)
10.Secondary Outcome
Title PTSD Checklist-military Version (PCL-M)
Hide Description Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.
Time Frame Post-treatment (2 weeks following last treatment session)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Videoteleconferencing AMT Face to Face AMT
Hide Arm/Group Description:

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.

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 videoteleconferencing modality.

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

Overall Number of Participants Analyzed 61 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
59.2  (15.0) 57.4  (16.0)
Time Frame Throughout the duration of the assessment and intervention, up to 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Videoteleconferencing AMT Face to Face AMT
Hide Arm/Group Description

The experimental arm is the group condition that received the AMT 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.

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

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

All-Cause Mortality
Videoteleconferencing AMT Face to Face AMT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Videoteleconferencing AMT Face to Face AMT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/64 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Videoteleconferencing AMT Face to Face AMT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/64 (0.00%) 
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.
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
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 ( US Department of Veterans Affairs )
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