Innovative Service Delivery for Secondary Prevention of PTSD
Innovative Service Delivery for Secondary Prevention of PTSD in At-Risk OIF-OEF Service Men and Women
研究概览
详细说明
OIF and OEF service men and women exposed to high levels of violence are at risk for developing mental health disorders including Post-traumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD). Even those with less severe symptoms who fail to meet diagnostic criteria for a mental health disorder may struggle to return to pre-deployment functioning. Studies suggest that a significant percentage of veterans may suffer from "subthreshold" PTSD; although their symptom presentation is less severe, these veterans experience emotional distress and reduced quality of life.
Given that Veterans Affairs (VA) mental-health service providers are faced with the important and challenging task of alleviating the emotional suffering of our service men and women while staying within budget confines, we need effective, practical, evidence-based treatments that can be delivered in an expedient and cost-effective manner. Thus, the current project has two primary objectives: 1) to develop, implement, and evaluate a treatment program (Behavioral Activation and Therapeutic Exposure, BATE) for OIF and OEF veterans with PTSD symptoms, and 2) to determine whether or not this program delivered via telepsychology will be as effective as in-person treatment. Secondary objectives include determining: 1) which treatment modality is more effective in terms of process variables (e.g., treatment satisfaction, session attendance), 2) which treatment modality is more cost-effective, and 3) whether treatment effects differ across race and gender. Study participants will be randomized to two treatment conditions, BATE delivered via telepsychology (BATE-T) and BATE delivered in-person (BATE-IP).
The current treatment protocol is based on two, research-supported therapeutic rationales, Behavioral Activation (BA) and Therapeutic Exposure (TE). Briefly, the treatment aims to increase the participant's engagement in healthy activities (i.e., activities that are naturally reinforcing and promote the participant's life values) and exposure activities (i.e., activities that target specific PTSD symptoms such as avoidance and hyperarousal). Treatment will be implemented in eight, one and half hour sessions. Although research supports the effectiveness of behavior- and exposure-based treatments for trauma-related mental health problems, a potential risk for any counseling program that targets avoidance symptoms is a temporary increase in emotional distress. Therapists will inform participants that this is a normal "side effect" of treatment. However, over the course of treatment should a participant's emotional distress rise to a level above what can be handled via outpatient counseling, the participant will be removed from the study and appropriate referrals will be made.
The anticipated duration of this study is four years. Based on results of the study, we will finalize the treatment manual. In terms of clinical applicability, we plan to present study findings at conferences and disseminate the treatment manual to VA mental health service providers in approximately four to five years. Study findings will address important gaps in the PTSD literature, yielding several contributions to the field. First, to the extent that BATE effectively reduces symptom severity, this investigational treatment may benefit individual OIF/OEF service men and women by alleviating emotional suffering and improving quality of life. Second, to the extent that BATE prevents the development of full-blown PTSD in subclinical military personnel, this investigational treatment may reduce attrition from the military due to untreated mental health problems. Third, only a small percentage of those who might benefit from counseling actually seek services due to barriers associated with traditional service delivery practices such as geographic distance from the VA hospital and stigma of psychological treatment. Thus, as telemedicine has been shown to circumvent these barriers to care, the current project has the potential to reach an otherwise underserved population: subclinical OIF and OEF service men and women who may be reluctant to seek care. Fourth, to the extent that BATE-T produces results comparable to BATE-IP, this study may potentially identify a cost-effective alternative to in-person treatment thereby reducing post-service treatment costs to VA's.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
South Carolina
-
Charleston、South Carolina、美国、29403
- Medical University of South Carolina
-
Charleston、South Carolina、美国、29403
- Ralph H. Johnson VAMC
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants will be OIF/OEF military personnel,
- age 21 and above, and
- with symptoms of posttraumatic stress disorder (PTSD) assigned on the basis of the Clinician Administered PTSD Scale (CAPS) and PTSD Checklist-Military (PCL-M).
Exclusion Criteria:
- Actively psychotic or demented persons,
- individuals with both suicidal ideation and clear intent, and
- individuals meeting criteria for substance dependence will be excluded from participation.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:BATE-T
Behavioral Activation Therapeutic Exposure done while the patient is at home via videoconferencing technology
|
This intervention combines Behavior Activation Therapy and Exposure Therapy to treat PTSD symptoms.
|
|
有源比较器:BATE-IP
Behavioral Activation Therapeutic Exposure done in the therapist's office
|
This intervention combines Behavior Activation Therapy and Exposure Therapy to treat PTSD symptoms.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The major objective of this study is to determine if Behavioral Activation with Therapeutic Exposure (BATE) delivered via Telemedicine is as effective as BATE In Person.
大体时间:1 year
|
This is measured in terms of (1) clinical (PTSD and Depression); (2) process (Treatment Satisfaction and Attrition); and (3) economic (Cost) outcomes.
|
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
贝克抑郁量表-II (BDI-II)
大体时间:基线
|
基线
|
|
|
贝克抑郁量表-II (BDI-II)
大体时间:3个月
|
3个月
|
|
|
临床医生管理的 PTSD 量表 (CAPS)
大体时间:8周
|
8周
|
|
|
Clinician Administered PTSD Scale (CAPS)
大体时间:Baseline
|
Baseline
|
|
|
Clinician Administered PTSD Scale (CAPS)
大体时间:3 months
|
3 months
|
|
|
Clinician Administered PTSD Scale (CAPS)
大体时间:1 year
|
1 year
|
|
|
The Deployment Risk and Resiliency Inventory (DRRI)
大体时间:Baseline
|
Baseline
|
|
|
PTSD Checklist-Military (PCL-M)
大体时间:Baseline
|
Baseline
|
|
|
PTSD Checklist-Military (PCL-M)
大体时间:4 weeks
|
4 weeks
|
|
|
PTSD Checklist-Military (PCL-M)
大体时间:8 weeks
|
8 weeks
|
|
|
PTSD Checklist-Military (PCL-M)
大体时间:3 months
|
3 months
|
|
|
PTSD Checklist-Military (PCL-M)
大体时间:1 year
|
1 year
|
|
|
Beck Depression Inventory-II (BDI-II)
大体时间:4 weeks
|
4 weeks
|
|
|
Beck Depression Inventory-II (BDI-II)
大体时间:8 weeks
|
8 weeks
|
|
|
Beck Depression Inventory-II (BDI-II)
大体时间:1 year
|
1 year
|
|
|
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
大体时间:Baseline
|
Baseline
|
|
|
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
大体时间:4 weeks
|
4 weeks
|
|
|
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
大体时间:8 weeks
|
8 weeks
|
|
|
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
大体时间:3 months
|
3 months
|
|
|
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
大体时间:1 year
|
1 year
|
|
|
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)
大体时间:8 weeks
|
8 weeks
|
|
|
Service Delivery Perceptions Questionnaire
大体时间:8 weeks
|
8 weeks
|
|
|
Prior Experience with Computer and Audiovisual Technology
大体时间:Baseline
|
Short measure to learn more about participants' prior experience and comfort level with computers and audiovisual technology
|
Baseline
|
合作者和调查者
调查人员
- 首席研究员:Ronald Acierno, PhD、VA Office of Research and Development
出版物和有用的链接
一般刊物
- Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.
- Acierno R, Rheingold A, Amstadter A, Kurent J, Amella E, Resnick H, Muzzy W, Lejuez C. Behavioral activation and therapeutic exposure for bereavement in older adults. Am J Hosp Palliat Care. 2012 Feb;29(1):13-25. doi: 10.1177/1049909111411471. Epub 2011 Jun 17.
- Gros DF, Price M, Yuen EK, Acierno R. Predictors of completion of exposure therapy in OEF/OIF veterans with posttraumatic stress disorder. Depress Anxiety. 2013 Nov;30(11):1107-13. doi: 10.1002/da.22207. Epub 2013 Oct 21.
- Gros DF, Price M, Strachan M, Yuen EK, Milanak ME, Acierno R. Behavioral activation and therapeutic exposure: an investigation of relative symptom changes in PTSD and depression during the course of integrated behavioral activation, situational exposure, and imaginal exposure techniques. Behav Modif. 2012 Jul;36(4):580-99. doi: 10.1177/0145445512448097. Epub 2012 Jun 7.
- Gros DF, Strachan M, Ruggiero KJ, Knapp RG, Frueh BC, Egede LE, Lejuez CW, Tuerk PW, Acierno R. Innovative service delivery for secondary prevention of PTSD in at-risk OIF-OEF service men and women. Contemp Clin Trials. 2011 Jan;32(1):122-8. doi: 10.1016/j.cct.2010.10.003. Epub 2010 Oct 14.
- Gros DF, Veronee K, Strachan M, Ruggiero KJ, Acierno R. Managing suicidality in home-based telehealth. J Telemed Telecare. 2011;17(6):332-5. doi: 10.1258/jtt.2011.101207. Epub 2011 Aug 15.
- Price M, Gros DF, Strachan M, Ruggiero KJ, Acierno R. Combat experiences, pre-deployment training, and outcome of exposure therapy for post-traumatic stress disorder in Operation Enduring Freedom/Operation Iraqi Freedom veterans. Clin Psychol Psychother. 2013 Jul-Aug;20(4):277-85. doi: 10.1002/cpp.1768. Epub 2012 Jan 18.
- Price M, Gros DF, Strachan M, Ruggiero KJ, Acierno R. The Role of Social Support in Exposure Therapy for Operation Iraqi Freedom/Operation Enduring Freedom Veterans: A Preliminary Investigation. Psychol Trauma. 2013 Jan 1;5(1):93-100. doi: 10.1037/a0026244.
- Strachan M, Gros DF, Ruggiero KJ, Lejuez CW, Acierno R. An integrated approach to delivering exposure-based treatment for symptoms of PTSD and depression in OIF/OEF veterans: preliminary findings. Behav Ther. 2012 Sep;43(3):560-9. doi: 10.1016/j.beth.2011.03.003. Epub 2011 May 24.
- Strachan M, Gros DF, Yuen E, Ruggiero KJ, Foa EB, Acierno R. Home-based telehealth to deliver evidence-based psychotherapy in veterans with PTSD. Contemp Clin Trials. 2012 Mar;33(2):402-9. doi: 10.1016/j.cct.2011.11.007. Epub 2011 Nov 11.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.