Posttraumatic Stress Disorder (PTSD)Phase 2DESTRESS-PCNCT01474057
DElivery of Self Training and Education for Stressful Situations-Primary Care Version
A Phase 2 study testing DESTRESS-PC and Optimized Usual Primary Care PTSD treatment in people with Posttraumatic Stress Disorder (PTSD), run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 4 sites in United States.
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". Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- DESTRESS-PC and Optimized Usual Primary Care PTSD treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2008to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Department of Veterans Affairs, Boston
Boston, Massachusetts, 02130
Ralph H. Johnson VA Medical Center/Goose Creek Primary Care Clinic (Charleston VA)
Charleston, South Carolina, 29425
Womack Army Medical Center
Fort Bragg, South Carolina, 28310
Savannah Primary Care Clinic (Charleston VA)
Savannah, Georgia, 31406
About this study
Official title: 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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- DESTRESS-PC, Optimized Usual Primary Care PTSD treatment
- Keywords
- PTSD, combat trauma, telemedicine, primary care interventions, CBT, self-managed treatment, web-based intervention, internet treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DESTRESS-PCBehavioural
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.
Optimized Usual Primary Care PTSD treatmentOther
Participants receive usual Primary Care treatment that is administered by the primary care physician; the DESTRESS Nurse monitors the participants' progress throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| DESTRESS-PC | Experimental | 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. Receives: Behavioral: DESTRESS-PC |
| OUC | Active comparator | 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. Receives: Other: Optimized Usual Primary Care PTSD treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks, 12 weeks, and 18 weeks post randomization
Secondary outcomes (4)
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.
Measured: baseline and 6 weeks,12 weeks, and 18 weeks post randomization
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.
Measured: baseline, 6 wks, 12 wks, and 18wks
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.
Measured: baseline, 6 weeks, 12 weeks, and 18 weeks
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.
Measured: baseline, 6 weeks, 12 weeks, and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startMay 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Charles Engel, Uniformed Services University of the Health Sciences
- Investigators
- Charles C. Engel, M.D., M.P.H., Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474057
- Sponsor's protocol ID
- W81XWH-07-2-0006
- Other IDs
- 1R34MH078874-01
- Acronym
- DESTRESS-PC
- Status last verified
- Jan 2012
- First submitted
- 26 Mar 2010
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 17974932Litz, 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.
PubMed 34015141
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Early Resilience Intervention for Combat-Related PTSD in Military Primary Healthcare Settings: A Randomized Trial of "DESTRESS-PC"
- ClinicalTrials.gov ID
- NCT01474057
- Acronym / sponsor ID
- DESTRESS-PC / W81XWH-07-2-0006
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- PTSD, combat trauma, telemedicine, primary care interventions, CBT, self-managed treatment, web-based intervention, internet treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- United States Department of Defense, National Institute of Mental Health (NIMH)
- Study start
- May 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DESTRESS-PC | Experimental | Behavioral: DESTRESS-PCA 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. |
| OUC | Active comparator | Other: Optimized Usual Primary Care PTSD treatmentOptimized 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DESTRESS-PCAn 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. | Behavioural | DESTRESS-PC |
| Optimized Usual Primary Care PTSD treatmentParticipants receive usual Primary Care treatment that is administered by the primary care physician; the DESTRESS Nurse monitors the participants' progress throughout the study. | Other | OUC |
Primary outcome
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.
4 secondary outcomes
PRIME-MD PHQ
Time frame: 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
Attitude Regarding Mental Health Treatments
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
- Background: PubMed 17974932Litz 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.
- BackgroundLitz, 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.
- Derived from this study: PubMed 34015141Simon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles C. Engel, M.D., M.P.H. principal investigator
Uniformed Services University of the Health Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DESTRESS-PC and Optimized Usual Primary Care PTSD treatment in people with Posttraumatic Stress Disorder (PTSD), run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist (PCL) (time frame: Baseline and 6 weeks, 12 weeks, and 18 weeks post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01474057, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2012.