Telemedicine and Anger Management Groups with PTSD Veterans in the Hawaiian Islands - Article
Clinical Trial: Telemedicine and Anger Management Groups with PTSD Veterans in the Hawaiian Islands
This study is not yet open for patient recruitment.
|Posttraumatic Stress Disorder |
| 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
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.
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
VA Pacific Islands Health Care System, Honolulu, Hawaii, 96819-1522, United States
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