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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 125 participants
• Primary outcome timeframe: Baseline
• Results posted on: 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=5 Participants	54.6 years n=7 Participants	54.7 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	64 Participants n=7 Participants	125 Participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants	64 participants n=7 Participants	125 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

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	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 videoteleconferencing modality. Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality.	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.
State-Trait Anger Inventory (STAXI-2) Anger Expression Index	55.0 units on a scale Standard Deviation 10.3	56.7 units on a scale Standard Deviation 12.0

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	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 videoteleconferencing modality. Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality.	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.
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale	46.6 units on a scale Standard Deviation 12.2	42.4 units on a scale Standard Deviation 16.2

PRIMARY outcome

Timeframe: 3-month Follow Up

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	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 videoteleconferencing modality. Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality.	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.
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale	47.0 units on a scale Standard Deviation 13.4	41.8 units on a scale Standard Deviation 15.3

PRIMARY outcome

Timeframe: 6-month Follow Up

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	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 videoteleconferencing modality. Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality.	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.
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale	46.6 units on a scale Standard Deviation 15.3	42.0 units on a scale Standard Deviation 15.6

PRIMARY outcome

Timeframe: Baseline

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	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 videoteleconferencing modality. Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality.	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.
Novaco Anger Scale (NAS)	109.8 units on a scale Standard Deviation 14.0	109.3 units on a scale Standard Deviation 16.1

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	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 videoteleconferencing modality. Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality.	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.
Novaco Anger Scale (NAS)	99.2 units on a scale Standard Deviation 17.1	94.2 units on a scale Standard Deviation 19.1

PRIMARY outcome

Timeframe: 3-Month Follow Up

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	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 videoteleconferencing modality. Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality.	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.
Novaco Anger Scale (NAS)	105.2 units on a scale Standard Deviation 19.2	96.4 units on a scale Standard Deviation 18.4

PRIMARY outcome

Timeframe: 6-Month Follow Up

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	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 videoteleconferencing modality. Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality.	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.
Novaco Anger Scale (NAS)	101.0 units on a scale Standard Deviation 22.5	97.7 units on a scale Standard Deviation 20.2

SECONDARY outcome

Timeframe: Baseline

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	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 videoteleconferencing modality. Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality.	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.
PTSD Checklist-military Version (PCL-M)	65.8 units on a scale Standard Deviation 10.8	64.5 units on a scale Standard Deviation 11.6

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	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 videoteleconferencing modality. Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality.	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.
PTSD Checklist-military Version (PCL-M)	57.4 units on a scale Standard Deviation 16.0	59.2 units on a scale Standard Deviation 15.0

Adverse Events

Videoteleconferencing AMT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Face to Face AMT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: (808) 566-1934

Email: leslie.morland@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place