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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Savannah Primary Care Clinic (Charleston VA)
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • Department of Veterans Affairs, Boston
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Ralph H. Johnson VA Medical Center/Goose Creek Primary Care Clinic (Charleston VA)
      • Ft. Bragg, South Carolina, United States, 28310
        • Womack Army Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Baseline and 6 weeks, 12 weeks, and 18 weeks post randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
baseline and 6 weeks,12 weeks, and 18 weeks post randomization
Medical Outcomes Study Short Form-36 (SF-36)
Time Frame: baseline, 6 wks, 12 wks, and 18wks
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
Attitude Regarding Mental Health Treatments
Time Frame: baseline, 6 weeks, 12 weeks, and 18 weeks
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
World Health Organization Health and Performance Questionnaire (HPQ).
Time Frame: baseline, 6 weeks, 12 weeks, and 18 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
United States Department of Defense

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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