Posttraumatic Stress DisorderNCT00122109
Telemedicine and Anger Management Groups With PTSD Veterans in the Hawaiian Islands
A study testing 12 sessions Anger Management Therapy. in people with Posttraumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- 12 sessions Anger Management Therapy.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male
- PTSD diagnosis
- anger level at Staxi Trait Score=22 or higher
- stable medication regime
Who cannot join
- current substance dependence
- current psychosis
- suicidal
- homicidal
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pacific Islands Health Care System, Honolulu, HI
Honolulu, Hawaii, 96819-1522
About this study
Official title: Telemedicine and Anger Management Groups for PTSD Veterans in the Hawaiian Islands
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- 12 sessions Anger Management Therapy.
- Keywords
- Posttraumatic Stress Disorder, Anger Management, Telemedicine modality
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 sessions Anger Management Therapy.Behavioural
Also called AMT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: 12 sessions Anger Management Therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-Month Follow Up
Secondary outcomes (2)
PTSD Checklist-military Version (PCL-M)
Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.
Measured: Baseline
PTSD Checklist-military Version (PCL-M)
Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.
Measured: Post-treatment (2 weeks following last treatment session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startAug 2005
- Primary completionOct 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Leslie A Morland, PsyD, Principal investigator, VA Pacific Islands Health Care System, Honolulu, HI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122109
- Sponsor's protocol ID
- TEL 03-080
- Status last verified
- Aug 2014
- First submitted
- 18 Jul 2005
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18956449Greene 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.
PubMed 20873910Morland 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.
PubMed 20122374Gros 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.
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.
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.
PubMed 21360528Mackintosh 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.
PubMed 24752837Morland 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.
PubMed 23931729
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine and Anger Management Groups for PTSD Veterans in the Hawaiian Islands
- ClinicalTrials.gov ID
- NCT00122109
- Acronym / sponsor ID
- TEL 03-080
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, Anger Management, Telemedicine modality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Jul 2005 (estimated)
- Results
- Posted 16 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videoteleconferencing AMT | Experimental | Behavioral: 12 sessions Anger Management Therapy.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. |
| Face to Face AMT | Active comparator | Behavioral: 12 sessions Anger Management Therapy.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male
- PTSD diagnosis
- anger level at Staxi Trait Score=22 or higher
- stable medication regime
Key exclusion criteria (5 listed)
- current substance dependence
- current psychosis
- suicidal
- homicidal
- cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12 sessions Anger Management Therapy.Also: AMTAnger 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. | Behavioural | Face to Face AMT, Videoteleconferencing AMT |
Primary outcome
State-Trait Anger Inventory (STAXI-2) Anger Expression Index
Time frame: Baseline
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.
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
Time frame: Post-treatment (2 weeks following last treatment session)
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.
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
Time frame: 3-month Follow Up
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.
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
Time frame: 6-month Follow Up
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.
Novaco Anger Scale (NAS)
Time frame: Baseline
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.
Novaco Anger Scale (NAS)
Time frame: Post-treatment (2 weeks following last treatment session)
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.
Novaco Anger Scale (NAS)
Time frame: 3-Month Follow Up
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.
Novaco Anger Scale (NAS)
Time frame: 6-Month Follow Up
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.
2 secondary outcomes
PTSD Checklist-military Version (PCL-M)
Time frame: Baseline
PTSD Checklist-military Version (PCL-M)
Time frame: Post-treatment (2 weeks following last treatment session)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18956449Greene 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.
- Results publication: PubMed 20873910Greene 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.
- Results publication: PubMed 20122374Morland 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.
- Results publicationGros 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.
- Results publicationMacdonald 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.
- Results publication: PubMed 21360528Morland 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.
- Results publication: PubMed 24752837Mackintosh 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.
- Results publication: PubMed 23931729Morland 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.
- National Center for PTSD provides and comprehensive information on the assessment, treatment, and epidemiology of Posttraumatic stress disorderLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie A Morland, PsyD principal investigator
VA Pacific Islands Health Care System, Honolulu, HI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 sessions Anger Management Therapy. in people with Posttraumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anger Inventory (STAXI-2) Anger Expression Index (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00122109, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.