- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01474057
DElivery of Self Training and Education for Stressful Situations-Primary Care Version (DESTRESS-PC)
January 11, 2012 updated by: Charles Engel, Henry M. Jackson Foundation for the Advancement of Military Medicine
Online Early Resilience Intervention for Combat-Related PTSD in Military Primary Healthcare Settings: A Randomized Trial of "DESTRESS-PC"
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
133
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Savannah, Georgia, United States, 31406
- Savannah Primary Care Clinic (Charleston VA)
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Massachusetts
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Boston, Massachusetts, United States, 02130
- Department of Veterans Affairs, Boston
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South Carolina
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Charleston, South Carolina, United States, 29425
- Ralph H. Johnson VA Medical Center/Goose Creek Primary Care Clinic (Charleston VA)
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Ft. Bragg, South Carolina, United States, 28310
- Womack Army Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
|
ACTIVE_COMPARATOR: 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.
|
Participants receive usual Primary Care treatment that is administered by the primary care physician; the DESTRESS Nurse monitors the participants' progress throughout the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Checklist (PCL)
Time Frame: Baseline and 6 weeks, 12 weeks, and 18 weeks post randomization
|
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.
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Baseline and 6 weeks, 12 weeks, and 18 weeks post randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PRIME-MD PHQ
Time Frame: baseline and 6 weeks,12 weeks, and 18 weeks post randomization
|
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.
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baseline and 6 weeks,12 weeks, and 18 weeks post randomization
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Medical Outcomes Study Short Form-36 (SF-36)
Time Frame: baseline, 6 wks, 12 wks, and 18wks
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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.
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baseline, 6 wks, 12 wks, and 18wks
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Attitude Regarding Mental Health Treatments
Time Frame: baseline, 6 weeks, 12 weeks, and 18 weeks
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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.
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baseline, 6 weeks, 12 weeks, and 18 weeks
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World Health Organization Health and Performance Questionnaire (HPQ).
Time Frame: baseline, 6 weeks, 12 weeks, and 18 weeks
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Charles C. Engel, M.D., M.P.H., Uniformed Services University of the Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (ACTUAL)
July 1, 2011
Study Completion (ACTUAL)
July 1, 2011
Study Registration Dates
First Submitted
March 26, 2010
First Submitted That Met QC Criteria
November 14, 2011
First Posted (ESTIMATE)
November 17, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
January 12, 2012
Last Update Submitted That Met QC Criteria
January 11, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- W81XWH-07-2-0006
- 1R34MH078874-01 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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