Trial Outcomes & Findings for Telemedicine and Anger Management Groups With PTSD Veterans in the Hawaiian Islands (NCT NCT00122109)
NCT ID: NCT00122109
Last Updated: 2015-04-28
Results Overview
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.
COMPLETED
NA
125 participants
Baseline
2015-04-28
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
64
|
|
Overall Study
COMPLETED
|
55
|
57
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Did not meet criteria
|
6
|
7
|
Baseline Characteristics
Telemedicine and Anger Management Groups With PTSD Veterans in the Hawaiian Islands
Baseline characteristics by cohort
| Measure |
Videoteleconferencing AMT
n=61 Participants
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
n=64 Participants
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
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.8 years
n=99 Participants
|
54.6 years
n=107 Participants
|
54.7 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=99 Participants
|
64 participants
n=107 Participants
|
125 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselineAnger 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.
Outcome measures
| Measure |
Videoteleconferencing AMT
n=61 Participants
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.
|
Face to Face AMT
n=64 Participants
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.
|
|---|---|---|
|
State-Trait Anger Inventory (STAXI-2) Anger Expression Index
|
56.7 units on a scale
Standard Deviation 12.0
|
55.0 units on a scale
Standard Deviation 10.3
|
PRIMARY outcome
Timeframe: Post-treatment (2 weeks following last treatment session)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.
Outcome measures
| Measure |
Videoteleconferencing AMT
n=61 Participants
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.
|
Face to Face AMT
n=64 Participants
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.
|
|---|---|---|
|
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
|
42.4 units on a scale
Standard Deviation 16.2
|
46.6 units on a scale
Standard Deviation 12.2
|
PRIMARY outcome
Timeframe: 3-month Follow UpAnger 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.
Outcome measures
| Measure |
Videoteleconferencing AMT
n=61 Participants
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.
|
Face to Face AMT
n=64 Participants
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.
|
|---|---|---|
|
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
|
41.8 units on a scale
Standard Deviation 15.3
|
47.0 units on a scale
Standard Deviation 13.4
|
PRIMARY outcome
Timeframe: 6-month Follow UpAnger 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.
Outcome measures
| Measure |
Videoteleconferencing AMT
n=61 Participants
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.
|
Face to Face AMT
n=64 Participants
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.
|
|---|---|---|
|
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
|
42.0 units on a scale
Standard Deviation 15.6
|
46.6 units on a scale
Standard Deviation 15.3
|
PRIMARY outcome
Timeframe: BaselineAnger 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.
Outcome measures
| Measure |
Videoteleconferencing AMT
n=61 Participants
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.
|
Face to Face AMT
n=64 Participants
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.
|
|---|---|---|
|
Novaco Anger Scale (NAS)
|
109.3 units on a scale
Standard Deviation 16.1
|
109.8 units on a scale
Standard Deviation 14.0
|
PRIMARY outcome
Timeframe: Post-treatment (2 weeks following last treatment session)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.
Outcome measures
| Measure |
Videoteleconferencing AMT
n=61 Participants
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.
|
Face to Face AMT
n=64 Participants
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.
|
|---|---|---|
|
Novaco Anger Scale (NAS)
|
94.2 units on a scale
Standard Deviation 19.1
|
99.2 units on a scale
Standard Deviation 17.1
|
PRIMARY outcome
Timeframe: 3-Month Follow UpAnger 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.
Outcome measures
| Measure |
Videoteleconferencing AMT
n=61 Participants
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.
|
Face to Face AMT
n=64 Participants
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.
|
|---|---|---|
|
Novaco Anger Scale (NAS)
|
96.4 units on a scale
Standard Deviation 18.4
|
105.2 units on a scale
Standard Deviation 19.2
|
PRIMARY outcome
Timeframe: 6-Month Follow UpAnger 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.
Outcome measures
| Measure |
Videoteleconferencing AMT
n=61 Participants
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.
|
Face to Face AMT
n=64 Participants
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.
|
|---|---|---|
|
Novaco Anger Scale (NAS)
|
97.7 units on a scale
Standard Deviation 20.2
|
101.0 units on a scale
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: BaselineSelf 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.
Outcome measures
| Measure |
Videoteleconferencing AMT
n=61 Participants
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.
|
Face to Face AMT
n=64 Participants
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.
|
|---|---|---|
|
PTSD Checklist-military Version (PCL-M)
|
64.5 units on a scale
Standard Deviation 11.6
|
65.8 units on a scale
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Post-treatment (2 weeks following last treatment session)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.
Outcome measures
| Measure |
Videoteleconferencing AMT
n=61 Participants
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.
|
Face to Face AMT
n=64 Participants
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.
|
|---|---|---|
|
PTSD Checklist-military Version (PCL-M)
|
59.2 units on a scale
Standard Deviation 15.0
|
57.4 units on a scale
Standard Deviation 16.0
|
Adverse Events
Videoteleconferencing AMT
Face to Face AMT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Leslie A. Morland, PsyD, Principal Investigator
VA Pacific Islands Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place