NCT00122109

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

October 16, 2014

Completed
Last Updated

April 28, 2015

Status Verified

August 1, 2014

Enrollment Period

3.2 years

First QC Date

July 18, 2005

Results QC Date

August 22, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

Posttraumatic Stress DisorderAnger ManagementTelemedicine modality

Outcome Measures

Primary Outcomes (8)

  • 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.

    Baseline

  • 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.

    Post-treatment (2 weeks following last treatment session)

  • 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.

    3-month Follow Up

  • 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.

    6-month Follow Up

  • 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.

    Baseline

  • 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.

    Post-treatment (2 weeks following last treatment session)

  • 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.

    3-Month Follow Up

  • 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.

    6-Month Follow Up

Secondary Outcomes (2)

  • PTSD Checklist-military Version (PCL-M)

    Baseline

  • PTSD Checklist-military Version (PCL-M)

    Post-treatment (2 weeks following last treatment session)

Study Arms (2)

Videoteleconferencing AMT

EXPERIMENTAL

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. Behavioral: 12 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.

Behavioral: 12 sessions Anger Management Therapy.

Face to Face AMT

ACTIVE COMPARATOR

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. Behavioral: 12 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.

Behavioral: 12 sessions Anger Management Therapy.

Interventions

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.

Also known as: AMT
Face to Face AMTVideoteleconferencing AMT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male
  • PTSD diagnosis
  • anger level at Staxi Trait Score=22 or higher
  • stable medication regime

You may not qualify if:

  • current substance dependence
  • current psychosis
  • suicidal
  • homicidal
  • cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pacific Islands Health Care System, Honolulu, HI

Honolulu, Hawaii, 96819-1522, United States

Location

Related Publications (8)

  • Greene CJ, Morland LA, Durkalski VL, Frueh BC. Noninferiority and equivalence designs: issues and implications for mental health research. J Trauma Stress. 2008 Oct;21(5):433-9. doi: 10.1002/jts.20367.

  • Greene CJ, Morland LA, Macdonald A, Frueh BC, Grubbs KM, Rosen CS. How does tele-mental health affect group therapy process? Secondary analysis of a noninferiority trial. J Consult Clin Psychol. 2010 Oct;78(5):746-50. doi: 10.1037/a0020158.

  • Morland LA, Greene CJ, Rosen CS, Foy D, Reilly P, Shore J, He Q, Frueh BC. Telemedicine for anger management therapy in a rural population of combat veterans with posttraumatic stress disorder: a randomized noninferiority trial. J Clin Psychiatry. 2010 Jul;71(7):855-63. doi: 10.4088/JCP.09m05604blu. Epub 2010 Jan 26.

  • 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.

    RESULT
  • 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.

    RESULT
  • Morland LA, Greene CJ, Grubbs K, Kloezeman K, Mackintosh MA, Rosen C, Frueh BC. Therapist adherence to manualized cognitive-behavioral therapy for anger management delivered to veterans with PTSD via videoconferencing. J Clin Psychol. 2011 Jun;67(6):629-38. doi: 10.1002/jclp.20779. Epub 2011 Feb 25.

  • Mackintosh MA, Morland LA, Kloezeman K, Greene CJ, Rosen CS, Elhai JD, Frueh BC. Predictors of anger treatment outcomes. J Clin Psychol. 2014 Oct;70(10):905-13. doi: 10.1002/jclp.22095. Epub 2014 Apr 17.

  • Morland LA, Raab M, Mackintosh MA, Rosen CS, Dismuke CE, Greene CJ, Frueh BC. Telemedicine: a cost-reducing means of delivering psychotherapy to rural combat veterans with PTSD. Telemed J E Health. 2013 Oct;19(10):754-9. doi: 10.1089/tmj.2012.0298. Epub 2013 Aug 9.

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Limitations and Caveats

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.

Results Point of Contact

Title
Leslie A. Morland, PsyD, Principal Investigator
Organization
VA Pacific Islands Healthcare System

Study Officials

  • Leslie A Morland, PsyD

    VA Pacific Islands Health Care System, Honolulu, HI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2005

First Posted

July 21, 2005

Study Start

August 1, 2005

Primary Completion

October 1, 2008

Study Completion

December 1, 2009

Last Updated

April 28, 2015

Results First Posted

October 16, 2014

Record last verified: 2014-08

Locations