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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00122109
First received: July 18, 2005
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
Behavioral: Anger Management Therapy (AMT) group treatment intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telemedicine and Anger Management Groups for PTSD Veterans in the Hawaiian Island

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 1. Anger symptom severity/reduction assessed using standardized scales including the State-Trait Anger Inventory (STAXI) , Novaco Anger Scale (NAS), and the Assault Behavior Scale (ABS) at baseline, mid-treatment and 3 and 6 months follow-up [ Time Frame: Our primary outcome of anger is assessed at baseline, mid-treatment, post-treatment and at 3 and 6 months follow-up treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Satisfaction, Therapeutic Alliance, Treatment Credibility, and Service Delivery Perception Credibility assessed using standardized scales at mid and post-treatment. [ Time Frame: Our secondary outcomes are assessed at baseline, mid-treatment, post-treatment and at 3 and 6 months follow-up treatment. ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: August 2005
Study Completion Date: December 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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.
Behavioral: Anger Management Therapy (AMT) group treatment intervention
12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality.

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 and the Novaco Anger Total Scale. 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. Results: Participants in both groups showed significant and clinically meaningful reductions in anger symptoms, with pre-post effect sizes ranging from .12 to .63. Participants in the VTC condition demonstrated a reduction in anger symptoms similar ("non-inferior") to symptom reductions in the in-person groups. Additionally, no significant between-group differences were found on the process variables of attrition, adherence, patient satisfaction, and treatment expectancy. Participants in the in-person condition reported significantly higher group therapy alliance. Impact: Telemental health may offer potential solutions for large health care systems that provide comprehensive services to patients in rural and remote areas. By demonstrating the effectiveness and feasibility of a cognitive-behavioral group treatment for PTSD-related anger problems delivered via VTC, this study provided support for the use of a VTC modality as a way to increase access to evidence-based care for veterans residing in rural or remote locations.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • current substance dependence,
  • current psychosis,
  • suicidal,
  • homicidal,
  • cognitive impairment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122109

Locations
United States, Hawaii
VA Pacific Islands Health Care System
Honolulu, Hawaii, United States, 96819-1522
Sponsors and Collaborators
Investigators
Principal Investigator: Leslie A Morland, PSYD VA Pacific Islands Health Care System
  More Information

Additional Information:
Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00122109     History of Changes
Other Study ID Numbers: TEL 03-080
Study First Received: July 18, 2005
Last Updated: August 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Posttraumatic Stress Disorder
Anger Management
Telemedicine modality

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014