Clinical trial NCT01474057: DElivery of Self Training and Education for Stressful Situations-Primary Care Version
Official title: Online Early Resilience Intervention for Combat-Related PTSD in Military Primary Healthcare Settings: A Randomized Trial of "DESTRESS-PC"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: PTSD
combat trauma
telemedicine
primary care interventions
CBT
self-managed treatment
web-based intervention
internet treatment
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: National Institute of Mental Health (NIMH)
First posted: 2011-11-17
Enrollment: 133
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PTSD Checklist (PCL)
timeFrame: Baseline and 6 weeks, 12 weeks, and 18 weeks post randomization
Secondary outcomes:
measure: PRIME-MD PHQ
timeFrame: baseline and 6 weeks,12 weeks, and 18 weeks post randomization
measure: Medical Outcomes Study Short Form-36 (SF-36)
timeFrame: baseline, 6 wks, 12 wks, and 18wks
measure: Attitude Regarding Mental Health Treatments
timeFrame: baseline, 6 weeks, 12 weeks, and 18 weeks
measure: World Health Organization Health and Performance Questionnaire (HPQ).
timeFrame: baseline, 6 weeks, 12 weeks, and 18 weeks
Other outcomes:
Locations:
city: Savannah
country: United States
facility: Savannah Primary Care Clinic (Charleston VA)
state: Georgia
city: Boston
country: United States
facility: Department of Veterans Affairs, Boston
state: Massachusetts
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center/Goose Creek Primary Care Clinic (Charleston VA)
state: South Carolina
city: Ft. Bragg
country: United States
facility: Womack Army Medical Center
state: South Carolina
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Charles C. Engel, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.