Innovative Service Delivery for Secondary Prevention of PTSD

PTSD Clinical Trial

Official title:

Innovative Service Delivery for Secondary Prevention of PTSD in At-Risk OIF-OEF Service Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177488
• Other study ID #: DoD Acierno
• Status: Completed
• Phase: N/A
• First received: April 12, 2010
• Last updated: September 11, 2015
• Start date: March 2008
• Est. completion date: February 2015

Study information

• Verified date: September 2015
• Source: Charleston Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether therapy for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) veterans with Post-traumatic Stress Disorder (PTSD) symptoms can be delivered effectively using videoconferencing technology ("telepsychology"), which allows a therapist and patient who are not in the same room as one another to communicate.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: February 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Behavioral Activation Therapeutic Exposure (BATE)
This intervention combines Behavior Activation Therapy and Exposure Therapy to treat PTSD symptoms.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Ralph H. Johnson VAMC	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Charleston Research Institute	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	This is measured in terms of (1) clinical (PTSD and Depression); (2) process (Treatment Satisfaction and Attrition); and (3) economic (Cost) outcomes.	1 year	No
Secondary	Clinician Administered PTSD Scale (CAPS)		Baseline	No
Secondary	Clinician Administered PTSD Scale (CAPS)		8 weeks	No
Secondary	Clinician Administered PTSD Scale (CAPS)		3 months	No
Secondary	Clinician Administered PTSD Scale (CAPS)		1 year	No
Secondary	The Deployment Risk and Resiliency Inventory (DRRI)		Baseline	No
Secondary	PTSD Checklist-Military (PCL-M)		Baseline	No
Secondary	PTSD Checklist-Military (PCL-M)		4 weeks	No
Secondary	PTSD Checklist-Military (PCL-M)		8 weeks	No
Secondary	PTSD Checklist-Military (PCL-M)		3 months	No
Secondary	PTSD Checklist-Military (PCL-M)		1 year	No
Secondary	Beck Depression Inventory-II (BDI-II)		Baseline	No
Secondary	Beck Depression Inventory-II (BDI-II)		4 weeks	No
Secondary	Beck Depression Inventory-II (BDI-II)		8 weeks	No
Secondary	Beck Depression Inventory-II (BDI-II)		3 months	No
Secondary	Beck Depression Inventory-II (BDI-II)		1 year	No
Secondary	Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)		Baseline	No
Secondary	Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)		4 weeks	No
Secondary	Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)		8 weeks	No
Secondary	Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)		3 months	No
Secondary	Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)		1 year	No
Secondary	Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)		8 weeks	No
Secondary	Service Delivery Perceptions Questionnaire		8 weeks	No
Secondary	Prior Experience with Computer and Audiovisual Technology	Short measure to learn more about participants' prior experience and comfort level with computers and audiovisual technology	Baseline	No