DElivery of Self Training and Education for Stressful Situations-Primary Care Version (DESTRESS-PC)

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status and phase: Completed; Phase 2

Conditions: Posttraumatic Stress Disorder (PTSD)

Treatments: Behavioral: DESTRESS-PC; Other: Optimized Usual Primary Care PTSD treatment

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT01474057

1R34MH078874-01 (U.S. NIH Grant/Contract)

W81XWH-07-2-0006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 133 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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133 participants in 2 patient groups

DESTRESS-PC

Experimental group

Description:

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.

Treatment:

Behavioral: DESTRESS-PC

OUC

Active Comparator group

Description:

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.

Treatment:

Other: Optimized Usual Primary Care PTSD treatment