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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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The study is a multi-site trial evaluating the efficacy of DESTRESS-PC (DElivery of Self-TRaining and Education for Stressful Situations, primary care version), a brief, web-based self-management intervention for PTSD designed for delivery in primary care. Participants randomized to DESTRESS-PC log on to a secure website for self-CBT 3 times per week for 6 weeks and receive RN nurse care manager ("DESTRESS Nurse") contact every two weeks. DESTRESS Nurses introduce the approach, monitor, answer questions, and insure primary care provider collaboration. The control intervention is optimized usual primary care. Blinded raters assess PTSD symptoms, depression, anxiety, somatic symptoms, physical health status, and occupational functioning at four timepoints. All study participants receive RN care management and are under the care of a primary care provider trained in evidence-based PTSD treatment who receives status reports from the DESTRESS nurse to include baseline psychiatric status.

Conditions

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Posttraumatic Stress Disorder (PTSD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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DESTRESS-PC

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.

Group Type EXPERIMENTAL

DESTRESS-PC

Intervention Type 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.

OUC

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.

Group Type ACTIVE_COMPARATOR

Optimized Usual Primary Care PTSD treatment

Intervention Type 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.

Interventions

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DESTRESS-PC

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.

Intervention Type BEHAVIORAL

Optimized Usual Primary Care PTSD treatment

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No