Clinical Trial: Telemedicine and Anger Management Groups with PTSD Veterans in the Hawaiian Islands

This study is not yet open for patient recruitment.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

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
Anger Management
Telemedicine modality
 Behavior: Anger Management Therapy (AMT) group treatment intervention

MedlinePlus related topics:  Post-Traumatic Stress Disorder

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: Telemedicine and Anger Management Groups for PTSD Veterans in the Hawaiian Island

Further Study Details: 
Primary Outcomes: 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
Secondary Outcomes: Satisfaction, Therapeutic Alliance, Treatment Credibility, and Service Delivery Perception Credibility assessed using standardized scales at mid and post-treatment.
Expected Total Enrollment:  180

Study start: August 2005;  Expected completion: March 2009
Last follow-up: June 2005;  Data entry closure: July 2008

will be randomly assigned to either the experimental VTC AMT group, or the control in-person AMT group. The manual-guided AMT consists of 12 session over 6 weeks with each session lasting 1.5 hours. Clinincal outcomes measures will be assesed pre-treatment, post-treatmet and at 3 and 6-months follow-up. Demonstration of equivalence between VTC and traditional-in-person modalities will be conducted using equivalence (non-inferiority) statistics. Testing the non-inferiority of the VTC mode of delivery to the In-Person mode will be carried out through a modified hypothesis testing procedure

Findings: No results at this time.

Status: Current start-up activities include hiring project staff and preparing for project protocol training and participant recruitment.

Impact: The recent interest in telemedicine in the VA system suggests the need for randomized trials comparing telemedicine services with traditional in-person services. Although telemedicine programs are surfacing across the nation, research that addresses the clinical effectiveness of this mode of service delivery is still desperately needed. This study will examine the clinical effectiveness of AMT via VTC modality. Further, findings from this project may support the establishment of a telemedicine infastructure in the VA system to provide care to veterans where distance limits access to specialized care. It is expected that this project will lead to results that can be applied to other VA situations where specialized clinical PTSD services, such as anger management groups, are needed but not available due to geographic distance.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male
Criteria

Inclusion Criteria: Clinical diagnosis of Alzheimer’s Disease Must be able to swallow tablets Or Patients must be less than 7 years old with amblyopia due to strabismus or anisometropia. Visual acuity in the amblyopic eye must be between 20/50 and20/10 Visual acuity in the sound eye of 20/40 or better, There must be at least 3 lines of acuity difference between the two eyes. Primary diagnosis of PTSD (current or lifetime) determined by the Clinician Administered PSTD Scale (CAPS-1) and confirmed by the SCID. A score of 22 or higher on the 10-item Trait Scale of the State-Trait Anger Expression Inventory Participants taking psychoative medications have to have a stable regimen for at least 2 months prior to study entry

Exclusion Criteria: Insulin dependent diabetes Thyroid Disease Or Patients with more than two months of amblyopia therapy in the past two years Active psychotic symptoms/disorder as determined by the SCID for DSM-IV Active homicidal or suicidal ideation as determined by the structured clinical interview Any significant cognitive impairment or history of Organic Mental Disorder as determined by the structured clinical interview Active (current) substance dependence as determined by the SCID (lifetime substance dependence or substance abuse not excluded) Unwillingness to refrain from substance abuse during treatment Females veterans

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00122109


Hawaii
      VA Pacific Islands Health Care System, Honolulu,  Hawaii,  96819-1522,  United States
Leslie A. Morland, PSYD  808-566-1934    Leslie.Morland@med.va.gov 

More Information

Study ID Numbers:  TEL 03-080
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122109
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26



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