Stress Disorders, PosttraumaticPhase 3RESPECT-PTSDNCT00373698
Re-Engineering Systems for the Primary Care Treatment for PTSD
A Phase 3 study testing Three Component Model of Collaborative Care in people with Stress Disorders, Posttraumatic and Depression, run by US Department of Veterans Affairs at 4 sites in United States.
Trial summary
The study is an evaluation of a systemic intervention to enhance the delivery of care according to practice guidelines for posttraumatic stress disorder (PTSD). The immediate objectives are to (1) implement three component model (3CM) in VA primary care clinics; and (2) evaluate the effects of 3CM on clinician… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Posttraumatic, Depression
- What is being tested?
- Three Component Model of Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2008to Apr 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Military Veterans in Primary Care Clinics who meet diagnostic criteria for PTSD in one of the 5 sites in Texas where this study is being conducted.
- Must have regular access to a telephone and speak English.
Who cannot join
- Cognitive impairment
- A history of psychosis or mania
- Prominent current suicidal ideation
- Current substance dependence
- Current engagement in mental health treatment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216
Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, 76504
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
Waco, Texas, 76711
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05009-0001
About this study
Official title: Reengineering Systems for the Primary Care Treatment of PTSD
The study is an evaluation of a systemic intervention to enhance the delivery of care according to practice guidelines for posttraumatic stress disorder (PTSD). The immediate objectives are to (1) implement three component model (3CM) in VA primary care clinics; and (2) evaluate the effects of 3CM on clinician behavior and patient outcomes. The long-term objectives are to generate information to support implementation research on the RESPECT model for treating PTSD in primary care and ultimately, the implementation of the model in VHA to provide care to veterans with PTSD.
Read the detailed description
3CM consists of (1) a prepared practice, (2) care management, and (3) enhanced mental health support. A prepared practice refers to education for primary care clinicians and office staff about practice guidelines and evidence-based care, the skills needed for use of assessment measures, and the use of communication forms and routines. The education plan consists of predisposing activities, including active teaching and learning, and enabling and reinforcing activities in order to help clinicians use newly acquired skills and to reinforce the continued use of these skills in practice. Care management is accomplished by telephone, usually by a centrally located care manager during acute phase treatment and follow up to answer patient questions, promote adherence to the clinician's management plan, and help patients overcome barriers to adherence. Enhanced mental health support is provided by a psychiatrist who supervises care managers by telephone, provides informal consultation to primary care clinicians, and helps to increase the quantity or quality of mental health referral resources.
- Conditions
- Stress Disorders, Posttraumatic, Depression
- Being tested
- Three Component Model of Collaborative Care
- Keywords
- Stress Disorders, Posttraumatic, Delivery of Health Care, Integrated, Primary Health Care, Veterans, Depression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three Component Model of Collaborative CareBehavioural
Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Three Component Model | Experimental | Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians. Receives: Behavioral: Three Component Model of Collaborative Care |
| Usual Care | No intervention | Patients randomized to "Usual Care" will receive care as usual by VA clinicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptom Severity
PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)
Measured: 3 and 6 months after initial assessment
Secondary outcomes (3)
Depression
Measure using the Hopkins Symptom Checklist-20
Measured: 3 and 6 months after initial assessment
SF-36 Mental Component
Measured: 3 and 6 months after initial assessment
SF-36 Physical Component
Measured: 3 and 6 months after initial assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startMar 2008
- Primary completionApr 2010
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, PosttraumaticStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paula P Schnurr, PhD, Principal investigator, White River Junction VA Medical Center, White River Junction, VT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373698
- Sponsor's protocol ID
- IAC 06-073
- Acronym
- RESPECT-PTSD
- Status last verified
- Jun 2014
- First submitted
- 6 Sep 2006
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Schnurr PP, Friedman MJ, Oxman TE, Dietrich AJ, Smith MW, Shiner B, Forshay E, Gui J, Thurston V. RESPECT-PTSD: re-engineering systems for the primary care treatment of PTSD, a randomized controlled trial. J Gen Intern Med. 2013 Jan;28(1):32-40. doi: 10.1007/s11606-012-2166-6. Epub 2012 Aug 3.
PubMed 22865017
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reengineering Systems for the Primary Care Treatment of PTSD
- ClinicalTrials.gov ID
- NCT00373698
- Acronym / sponsor ID
- RESPECT-PTSD / IAC 06-073
- Conditions
- Stress Disorders, Posttraumatic, Depression
- Keywords
- Stress Disorders, Posttraumatic, Delivery of Health Care, Integrated, Primary Health Care, Veterans, Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Posted 7 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is an evaluation of a systemic intervention to enhance the delivery of care according to practice guidelines for posttraumatic stress disorder (PTSD). The immediate objectives are to (1) implement three component model (3CM) in VA primary care clinics; and (2) evaluate the effects of 3CM on clinician behavior and patient outcomes. The long-term objectives are to generate information to support implementation research on the RESPECT model for treating PTSD in primary care and ultimately, the implementation of the model in VHA to provide care to veterans with PTSD.
Detailed description
3CM consists of (1) a prepared practice, (2) care management, and (3) enhanced mental health support. A prepared practice refers to education for primary care clinicians and office staff about practice guidelines and evidence-based care, the skills needed for use of assessment measures, and the use of communication forms and routines. The education plan consists of predisposing activities, including active teaching and learning, and enabling and reinforcing activities in order to help clinicians use newly acquired skills and to reinforce the continued use of these skills in practice. Care management is accomplished by telephone, usually by a centrally located care manager during acute phase treatment and follow up to answer patient questions, promote adherence to the clinician's management plan, and help patients overcome barriers to adherence. Enhanced mental health support is provided by a psychiatrist who supervises care managers by telephone, provides informal consultation to primary care clinicians, and helps to increase the quantity or quality of mental health referral resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three Component Model | Experimental | Behavioral: Three Component Model of Collaborative CareThree Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians. |
| Usual Care | No intervention | –Patients randomized to "Usual Care" will receive care as usual by VA clinicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Military Veterans in Primary Care Clinics who meet diagnostic criteria for PTSD in one of the 5 sites in Texas where this study is being conducted.
- Must have regular access to a telephone and speak English.
Key exclusion criteria (5 listed)
- Cognitive impairment
- A history of psychosis or mania
- Prominent current suicidal ideation
- Current substance dependence
- Current engagement in mental health treatment
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 |
|---|---|---|
| Three Component Model of Collaborative CarePatients randomized to 3CM will receive telephone care management along with usual care by VA clinicians. | Behavioural | Three Component Model |
Primary outcome
PTSD Symptom Severity
Time frame: 3 and 6 months after initial assessment
PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)
3 secondary outcomes
Depression
Time frame: 3 and 6 months after initial assessment
SF-36 Mental Component
Time frame: 3 and 6 months after initial assessment
SF-36 Physical Component
Time frame: 3 and 6 months after initial assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22865017Schnurr PP, Friedman MJ, Oxman TE, Dietrich AJ, Smith MW, Shiner B, Forshay E, Gui J, Thurston V. RESPECT-PTSD: re-engineering systems for the primary care treatment of PTSD, a randomized controlled trial. J Gen Intern Med. 2013 Jan;28(1):32-40. doi: 10.1007/s11606-012-2166-6. Epub 2012 Aug 3.
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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.
Paula P Schnurr, PhD principal investigator
White River Junction VA Medical Center, White River Junction, VT
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Three Component Model of Collaborative Care in people with Stress Disorders, Posttraumatic and Depression, run by US Department of Veterans Affairs 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 2 inclusion and 5 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 24 Apr 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Symptom Severity (time frame: 3 and 6 months after initial assessment). 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 NCT00373698, which also lists 1 linked publication.
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 24 Apr 2015.