NCT01177488

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

6.4 years

First QC Date

April 12, 2010

Last Update Submit

September 11, 2015

Conditions

PTSD

Keywords

MilitaryHealth Service DeliveryBehavioral SymptomsTelepsychologyBehavioral ActivationExposure TherapyVeteransTelemedicine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (23)

  • Clinician Administered PTSD Scale (CAPS)

    Baseline

  • Clinician Administered PTSD Scale (CAPS)

    8 weeks

  • Clinician Administered PTSD Scale (CAPS)

    3 months

  • Clinician Administered PTSD Scale (CAPS)

    1 year

  • The Deployment Risk and Resiliency Inventory (DRRI)

    Baseline

  • +18 more secondary outcomes

Study Arms (2)

BATE-T

EXPERIMENTAL

Behavioral Activation Therapeutic Exposure done while the patient is at home via videoconferencing technology

Behavioral: Behavioral Activation Therapeutic Exposure (BATE)

BATE-IP

ACTIVE COMPARATOR

Behavioral Activation Therapeutic Exposure done in the therapist's office

Behavioral: Behavioral Activation Therapeutic Exposure (BATE)

Interventions

Behavioral Activation Therapeutic Exposure (BATE)BEHAVIORAL

This intervention combines Behavior Activation Therapy and Exposure Therapy to treat PTSD symptoms.

BATE-IPBATE-T

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Ralph H. Johnson VAMC

Charleston, South Carolina, 29403, United States

Location

Related 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.

    PMID: 21685428BACKGROUND

  • 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.

    PMID: 24151141BACKGROUND

  • 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.

    PMID: 22679240BACKGROUND

  • 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.

    PMID: 20951235BACKGROUND

  • 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.

    PMID: 21844180BACKGROUND

  • 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.

    PMID: 21324944BACKGROUND

  • 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.

    PMID: 22253233BACKGROUND

  • 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.

    PMID: 23869250BACKGROUND

  • 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.

    PMID: 22697444BACKGROUND

  • 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.

    PMID: 22101225BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticBehavioral Symptoms

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavior

Study Officials

  • Ronald Acierno, PhD

    VA Office of Research and Development

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2010

First Posted

August 9, 2010

Study Start

March 1, 2008

Primary Completion

August 1, 2014

Study Completion

February 1, 2015

Last Updated

September 14, 2015

Record last verified: 2015-09

Locations

US(2)