Posttraumatic Stress Disorder
Conditions
Keywords
Posttraumatic Stress Disorder, Anger Management, Telemedicine modality
Brief summary
Telemedicine has the potential to profoundly influence the delivery of specialized care to the remote veteran population suffering with PTSD. Preliminary research supports telemedicine technology as a possible solution to improve access to mental health services for veterans with PTSD. The proposed research is a treatment-outcome study that will assess the clinical efficacy of conducting an Anger Management Therapy (AMT) group treatment intervention using a videoteleconferencing (VTC) modality as compared to the traditional in-person modality with veterans who have PTSD and reside in remote locations on the Hawaiian Islands. AMT is a manual-guided cognitive-behavioral, skill based group intervention that has been used nationwide in VA substance abuse programs and most recently has been adopted by many VA PTSD Clinical Teams to treat anger-related to the sequelae of PTSD.
Detailed description
Background: Posttraumatic stress disorder (PTSD) is a prevalent problem among military troops. Recovery from combat-related PTSD is often complicated by problems with anger. Veterans with difficulties managing PTSD-related anger may be particularly likely to live in remote geographical regions where access to specialized mental health care is often limited. Telemental health (TMH) has been touted as a potential means of increasing access to care in rural or remote areas. Objectives: This study compared the effectiveness of group Anger Management Therapy (AMT) delivered via videoteleconferencing (VTC) and in-person delivery in a sample of rural combat veterans with PTSD. The long-range objective of this project was to develop an empirically sound TMH protocol that will facilitate the extension of manual guided clinical services to remote sites via VTC. We hypothesized that providing a manualized group therapy intervention via VTC would result in similar reductions in anger symptoms as obtained from traditional in-person care. Further, we hypothesized that key process indicators (i.e., attrition, adherence, satisfaction, and therapeutic alliance) would not be significantly different between the VTC and in-person conditions. The specific objectives of this project were to: a) determine if group AMT delivered via VTC is as effective as the same intervention delivered in-person on clinical outcomes measuring reductions in anger symptoms and b) determine if group AMT delivered via VTC is as effective as the same intervention delivered in-person on group process outcomes. Methods: A randomized controlled non-inferiority trial of 125 male veterans with PTSD and anger difficulties was conducted at three Department of Veterans Affairs' outpatient clinics. Participants were randomly assigned to receive AMT delivered in a group setting with the therapist either in-person (N= 64) or via VTC (N= 61). Participants were assessed at baseline, mid-treatment, post-treatment, and 3 and 6-months post-treatment. The primary clinical outcome was reduction of anger difficulties, as measured by the Anger Expression and Trait Anger subscales of the State-Trait Anger Expression Inventory (STAXI-2) and the Novaco Anger Total Scale (NAS). Process variables were measured to assess the feasibility of AMT delivered via VTC. SAS MEANS procedure was used to calculate means and standard deviations for change from baseline at subsequent assessment points for both intent-to-treat and per-protocol analysis.
Interventions
BEHAVIORAL12 sessions Anger Management Therapy.
Anger Management Treatment (AMT), a 12-session manual-driven cognitive-behavioral intervention developed and found efficacious for anger management treatment with substance abuse veterans and has been applied to the PTSD population. AMT is highly structured with both psychoeducational and psychotherapy components. AMT is aimed at reducing anger affect and aggression through increasing anger management skills.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male * PTSD diagnosis * anger level at Staxi Trait Score=22 or higher * stable medication regime
Exclusion criteria
* current substance dependence * current psychosis * suicidal * homicidal * cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anger Inventory (STAXI-2) Anger Expression Index | 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. |
| State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale | 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. |
| Novaco Anger Scale (NAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist-military Version (PCL-M) | 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. |
Countries
United States
Participant flow
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| 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. | 64 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet criteria | 6 | 7 |
Baseline characteristics
| Characteristic | Videoteleconferencing AMT | Face to Face AMT | Total |
|---|---|---|---|
| Age, Continuous | 54.8 years | 54.6 years | 54.7 years |
| Region of Enrollment United States | 61 participants | 64 participants | 125 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 61 Participants | 64 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 61 | 0 / 64 |
| serious Total, serious adverse events | 0 / 61 | 0 / 64 |
Outcome results
Primary
Novaco Anger Scale (NAS)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoteleconferencing AMT | Novaco Anger Scale (NAS) | 109.3 units on a scale | Standard Deviation 16.1 |
| Face to Face AMT | Novaco Anger Scale (NAS) | 109.8 units on a scale | Standard Deviation 14 |
Primary
Novaco Anger Scale (NAS)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoteleconferencing AMT | Novaco Anger Scale (NAS) | 97.7 units on a scale | Standard Deviation 20.2 |
| Face to Face AMT | Novaco Anger Scale (NAS) | 101.0 units on a scale | Standard Deviation 22.5 |
Primary
Novaco Anger Scale (NAS)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoteleconferencing AMT | Novaco Anger Scale (NAS) | 96.4 units on a scale | Standard Deviation 18.4 |
| Face to Face AMT | Novaco Anger Scale (NAS) | 105.2 units on a scale | Standard Deviation 19.2 |
Primary
Novaco Anger Scale (NAS)
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoteleconferencing AMT | Novaco Anger Scale (NAS) | 94.2 units on a scale | Standard Deviation 19.1 |
| Face to Face AMT | Novaco Anger Scale (NAS) | 99.2 units on a scale | Standard Deviation 17.1 |
Primary
State-Trait Anger Inventory (STAXI-2) Anger Expression Index
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoteleconferencing AMT | State-Trait Anger Inventory (STAXI-2) Anger Expression Index | 56.7 units on a scale | Standard Deviation 12 |
| Face to Face AMT | State-Trait Anger Inventory (STAXI-2) Anger Expression Index | 55.0 units on a scale | Standard Deviation 10.3 |
Primary
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoteleconferencing AMT | State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale | 42.0 units on a scale | Standard Deviation 15.6 |
| Face to Face AMT | State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale | 46.6 units on a scale | Standard Deviation 15.3 |
Primary
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoteleconferencing AMT | State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale | 41.8 units on a scale | Standard Deviation 15.3 |
| Face to Face AMT | State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale | 47.0 units on a scale | Standard Deviation 13.4 |
Primary
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoteleconferencing AMT | State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale | 42.4 units on a scale | Standard Deviation 16.2 |
| Face to Face AMT | State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale | 46.6 units on a scale | Standard Deviation 12.2 |
Secondary
PTSD Checklist-military Version (PCL-M)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoteleconferencing AMT | PTSD Checklist-military Version (PCL-M) | 64.5 units on a scale | Standard Deviation 11.6 |
| Face to Face AMT | PTSD Checklist-military Version (PCL-M) | 65.8 units on a scale | Standard Deviation 10.8 |
Secondary
PTSD Checklist-military Version (PCL-M)
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Videoteleconferencing AMT | PTSD Checklist-military Version (PCL-M) | 59.2 units on a scale | Standard Deviation 15 |
| Face to Face AMT | PTSD Checklist-military Version (PCL-M) | 57.4 units on a scale | Standard Deviation 16 |