DElivery of Self Training and Education for Stressful Situations-Primary Care Version

NCT01474057 | Completed Phase 2 DMC

• 2 other identifiers: W81XWH-07-2-00061R34MH078874-01
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 4

Brief Summary

This study will compare a cognitive-behavioral online self-management intervention designed for primary care treatment of war-related PTSD to a control intervention, "optimized usual primary care PTSD treatment". Patients with PTSD will be trained to use the online PTSD treatment website and asked to do so three times per week for six weeks. They will have phone and email access to a nurse trained to assist them in their treatment program. Three scheduled phone check-ins during the six week treatment period will provide ongoing contact with patients during treatment. The investigators will assess PTSD symptoms, depression, anxiety and somatic symptoms, physical health status and occupational functioning on three occasions: before the intervention, at the end of the treatment period, and six weeks after the end of treatment.

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

PTSD; combat trauma; telemedicine; primary care interventions; CBT; self-managed treatment; web-based intervention; internet treatment

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist (PCL)

  Symptoms of PTSD were assessed using the PTSD Checklist-Military Version (PCL). The PCL is a self-report measure developed for measuring PTSD symptom severity and for estimating PTSD caseness when administration of a structured clinical interview is not feasible. Respondents rate PCL items on a 5-point scale ('not at all' through "extremely') to indicate the degree to which they have been bothered by each of 17 PTSD symptoms during the past month. Possible PCL scores range from 17 to 85.

  Baseline and 6 weeks, 12 weeks, and 18 weeks post randomization

Secondary Outcomes (4)

• PRIME-MD PHQ

  baseline and 6 weeks,12 weeks, and 18 weeks post randomization

• Medical Outcomes Study Short Form-36 (SF-36)

  baseline, 6 wks, 12 wks, and 18wks

• Attitude Regarding Mental Health Treatments

  baseline, 6 weeks, 12 weeks, and 18 weeks

• World Health Organization Health and Performance Questionnaire (HPQ).

  baseline, 6 weeks, 12 weeks, and 18 weeks

Study Arms (2)

DESTRESS-PC

EXPERIMENTAL

A brief, nurse-assisted, Internet-based online self-management tool for PTSD (DESTRESS-PC), based on empirically valid cognitive-behavioral therapy (CBT) strategies and designed for implementation in a primary care setting. DESTRESS-PC stands for DElivery of Self-TRaining and Education for Stressful Situations for Primary Care.

Behavioral: DESTRESS-PC

OUC

ACTIVE COMPARATOR

Optimized Usual Care (OUC) for PTSD--usual PTSD treatment offered within the primary care setting, optimized by training PC providers in PTSD identification and treatment and providing basic care management including phone check-ins to monitor symptoms and feedback to providers.

Other: Optimized Usual Primary Care PTSD treatment

Interventions

DESTRESS-PC BEHAVIORAL

An online nurse-assisted, self-management intervention designed for primary care treatment of war-related PTSD, this intervention will consist of 3 weekly logins to a secure website for a period of 6 weeks. A "DESTRESS Nurse" will train the participant to use the website and will monitor their progress and report key information back to the primary care physician.

DESTRESS-PC

Optimized Usual Primary Care PTSD treatment OTHER

Participants receive usual Primary Care treatment that is administered by the primary care physician; the DESTRESS Nurse monitors the participants' progress throughout the study.

OUC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred by a primary care providers in a participating primary care clinic.
• Deployed to either Operation Iraqi Freedom or Enduring Freedom.
• War-related trauma while deployed (may include military sexual trauma).
• Current PTSD as addressed by the CAPS interview.
• Reports routine access to computer, internet, and email.
• Successfully uses Internet to coordinate baseline assessment appointment.
• Provides research informed consent using local IRB-approved form.
• Plans continued care at the enrolling primary care clinic for at least 4 months.

You may not qualify if:

• Actively engaged in specialty mental health care in the previous two months.
• Failed specialty mental health treatment for PTSD or associated condition.
• Acute psychosis, psychotic episode, or psychotic disorder diagnosis within the past two years.
• Active substance dependence disorder in the past year.
• Active suicidal or violent ideation within the past two months.
• Currently on an antipsychotic or mood-stabilizing agent.
• Unstable administration schedule or dosing of any antidepressant, anxiolytic, or sedative-hypnotic (i.e., will exclude for any related medication changes in the two-months prior to randomization).
• Acute or unstable physical illness.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• United States Department of Defense: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Savannah Primary Care Clinic (Charleston VA)

Savannah, Georgia, 31406, United States

Location

Department of Veterans Affairs, Boston

Boston, Massachusetts, 02130, United States

Location

Ralph H. Johnson VA Medical Center/Goose Creek Primary Care Clinic (Charleston VA)

Charleston, South Carolina, 29425, United States

Location

Womack Army Medical Center

Fort Bragg, South Carolina, 28310, United States

Location

Related Publications (3)

• Litz BT, Engel CC, Bryant RA, Papa A. A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder. Am J Psychiatry. 2007 Nov;164(11):1676-83. doi: 10.1176/appi.ajp.2007.06122057.

  PMID: 17974932 BACKGROUND

• Litz, BT, Williams, L, Wang, J, Bryant, R, and Engel, CC. A Therapist-Assisted Internet Self-Help Program for Traumatic Stress. Professional Psychology: Research and Practice 35(6):628-634, 2004.

  BACKGROUND

• Simon N, Robertson L, Lewis C, Roberts NP, Bethell A, Dawson S, Bisson JI. Internet-based cognitive and behavioural therapies for post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2021 May 20;5(5):CD011710. doi: 10.1002/14651858.CD011710.pub3.

  PMID: 34015141 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Charles C. Engel, M.D., M.P.H.

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dir., Deployment Health Clinical Center, WRNMMC; Associate Professor, psychiatry, USUHS

Study Record Dates

• First Submitted: March 26, 2010
• First Posted: November 17, 2011
• Study Start: May 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 12, 2012

Record last verified: 2012-01

Locations

US (4)