Clinical trial NCT00122109: Telemedicine and Anger Management Groups With PTSD Veterans in the Hawaiian Islands
Official title: Telemedicine and Anger Management Groups for PTSD Veterans in the Hawaiian Islands
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
Anger Management
Telemedicine modality
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-07-21
Enrollment: 125
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: State-Trait Anger Inventory (STAXI-2) Anger Expression Index
timeFrame: Baseline
measure: State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
timeFrame: Post-treatment (2 weeks following last treatment session)
measure: State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
timeFrame: 3-month Follow Up
measure: State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
timeFrame: 6-month Follow Up
measure: Novaco Anger Scale (NAS)
timeFrame: Baseline
measure: Novaco Anger Scale (NAS)
timeFrame: Post-treatment (2 weeks following last treatment session)
measure: Novaco Anger Scale (NAS)
timeFrame: 3-Month Follow Up
measure: Novaco Anger Scale (NAS)
timeFrame: 6-Month Follow Up
Secondary outcomes:
measure: PTSD Checklist-military Version (PCL-M)
timeFrame: Baseline
measure: PTSD Checklist-military Version (PCL-M)
timeFrame: Post-treatment (2 weeks following last treatment session)
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: VA Pacific Islands Health Care System, Honolulu, HI
state: Hawaii
Study officials:
affiliation: VA Pacific Islands Health Care System, Honolulu, HI
name: Leslie A Morland, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.