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

Posttraumatic Stress Disorder (PTSD) Clinical Trial

— DESTRESS-PC  

Official title:

Online Early Resilience Intervention for Combat-Related PTSD in Military Primary Healthcare Settings: A Randomized Trial of "DESTRESS-PC"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474057
• Other study ID #: W81XWH-07-2-0006
• Secondary ID: 1R34MH078874-01
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2010
• Last updated: January 11, 2012
• Start date: May 2008
• Est. completion date: July 2011

Study information

• Verified date: January 2012
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
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	Ft. Bragg	South Carolina
United States	Savannah Primary Care Clinic (Charleston VA)	Savannah	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	National Institute of Mental Health (NIMH), United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	PRIME-MD PHQ	The PHQ is a brief self-report assessment of common mental disorders developed specifically for primary care. PHQ allows brief provisional primary care diagnoses of several disorders including major depression, panic disorder, other anxiety disorder, and multi-somatoform disorder. We used the PHQ for baseline and follow-up assessments of depression, anxiety (panic and generalized anxiety), and somatic symptom severity, assessments with excellent correspondence to DSM-IV diagnostic criteria.	baseline and 6 weeks,12 weeks, and 18 weeks post randomization	No
Secondary	Medical Outcomes Study Short Form-36 (SF-36)	The SF-36 is a widely used measure of health related quality of life with established reliability and validity. The SF-36 was used to describe the study sample, compare functional status of the intervention groups at baseline, and assess change in functional over the course of the study.	baseline, 6 wks, 12 wks, and 18wks	No
Secondary	Attitude Regarding Mental Health Treatments	We used two questions from Hoge and colleagues (2004): 'I don't trust mental health professionals,' and 'Mental health care doesn't work.' Both questions are rated using a five-point Likert-type scale. We also used two questions that rate attitudes regarding psychotherapy treatment ('Psychotherapy patients are wasting money,' and 'Therapy can help an individual'). The latter two questions, rated on the same 5-point scale, were part of a longer measure used to evaluate stigma in primary care patients with anxiety disorders.	baseline, 6 weeks, 12 weeks, and 18 weeks	No
Secondary	World Health Organization Health and Performance Questionnaire (HPQ).	The HPQ is an assessment instrument to estimate the costs of workplace health problems using a self-report instrument. Specific areas assessed include job performance, absenteeism, and work related critical incidents.	baseline, 6 weeks, 12 weeks, and 18 weeks	No