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

Completed · Phase 2

Conditions studied: Posttraumatic Stress Disorder (PTSD)

In brief

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.

Key facts

Study ID

NCT01474057

Run by

Henry M. Jackson Foundation for the Advancement of Military Medicine

People needed

133

Starts

2008-05-01

Expected to finish

2011-07-01

Last updated by the study team

2012-01-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Savannah Primary Care Clinic (Charleston VA) — Savannah, Georgia, United States
• Department of Veterans Affairs, Boston — Boston, Massachusetts, United States
• Ralph H. Johnson VA Medical Center/Goose Creek Primary Care Clinic (Charleston VA) — Charleston, South Carolina, United States
• Womack Army Medical Center — Fort Bragg, South Carolina, United States

Full record on ClinicalTrials.gov

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