Post-Traumatic Stress DisorderNCT00680524
Telephone-based Care for OEF/OIF Veterans With PTSD
A study testing Phone-based outreach in people with Post-Traumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Objective: OEF/OIF (Operation Enduring Freedom and Operation Iraqi Freedom) veterans are presenting with high rates of PTSD. Translating Initiatives for Depression into Effective Solutions (TIDES) is a model of phone-based care being implemented nationally as a model to address those patients suffering from… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Phone-based outreach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2009
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PTSD
- Operation Enduring Freedom and Operation Iraqi Freedom veteran
Who cannot join
- no phone
- severe brain injury
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: Telephone Based Care for OIF/OEF Veterans With PTSD
Objective: OEF/OIF (Operation Enduring Freedom and Operation Iraqi Freedom) veterans are presenting with high rates of PTSD. Translating Initiatives for Depression into Effective Solutions (TIDES) is a model of phone-based care being implemented nationally as a model to address those patients suffering from depression, PTSD, or alcohol use disorders. However, evidence-based treatments do not yet exist for phone-based management of OEF/OIF veterans who suffer from PTSD.
Research Plan:
This is an open trial to assess feasibility of augmenting standard treatment of PTSD with TIDES based telephone-based nurse care management.
Read the detailed description
Background:
Veterans from Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) present with high rates of post-traumatic stress disorder (PTSD) and depressive disorders, but may experience barriers to specialty mental health (MH) care. Recent research suggests the majority of OEF/OIF veterans referred to MH for PTSD or depression fail to attend the recommended number of appointments within the first year. The TIDES (Translating Initiatives for Depression into Effective Solutions) model of collaborative care management for depression is an evidence-based option for VA primary care settings. However, patients in TIDES care management often have co-morbid PTSD, and the current model does not include PTSD-specific tools.
Objectives:
The primary objectives of the project were to assess feasibility and acceptability of (1) adapting TIDES tools and protocols to include PTSD and depression in the management of OEF/OIF patients, and (2) implementing the adapted model to augment treatment as usual in the VA Seattle-Puget Sound Deployment Health Clinic (DHC).
Methods:
We conducted a pilot implementation of the TIDES/PTSD model in a single site that provides integrated care specifically for OEF/OIF veterans. TIDES CPRS (Computerized Patient Record System) templates were adapted to include assessment and monitoring for PTSD. Phone-based care management protocols were expanded to include PTSD in three clinical domains: (1) medication management, (2) psychosocial support, and (3) patient self-management support, including the optional workbook "Strategies for Managing Stress After the War: Veterans Workbook." The templates were written in VA Class 1 Software, and clinical data were coded as Health Factors, allowing for automatic collection into the VISN 20 Data Warehouse. TIDES Care Managers were trained to use these templates, protocols, and workbook. Clinical staff received an orientation to the model of care. We enrolled 20 patients, newly initiating care at the DHC, who had a clinical diagnosis of PTSD and score of 50 or greater on the PTSD Check List-Military version (PCL-M). Co-morbid depression, if present, was defined by clinical diagnosis and a score of 10 or greater on the nine-item Patient Health Questionnaire (PHQ-9). Patients were followed by a Care Manager for up to six months. Formative evaluation included utilization data, clinical data, and qualitative data from semi-structured interviews of clinical staff and patients on their experiences with the model.
Status:
Final report.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Phone-based outreach
- Keywords
- telephone-based intervention for PTSD
- 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.
Phone-based outreachOther
Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD
| Study group | Role | What they receive |
|---|---|---|
| Phone Based Outreach Intervention Group | Experimental | Open pilot trial Receives: Other: Phone-based outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability to Providers and Patients
Patients and providers rated the components of the intervention on a 5 point scale where 1 = poor and 5 = excellent and average ratings for each group is reported below
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionSep 2009
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.
- Other trials for Post-Traumatic Stress DisorderStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Bradford L. Felker, MD BA, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680524
- Sponsor's protocol ID
- SHP 08-184
- Status last verified
- Jun 2014
- First submitted
- 16 May 2008
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Based Care for OIF/OEF Veterans With PTSD
- ClinicalTrials.gov ID
- NCT00680524
- Acronym / sponsor ID
- SHP 08-184
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- telephone-based intervention for PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 May 2008 (estimated)
- Results
- Posted 26 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: OEF/OIF (Operation Enduring Freedom and Operation Iraqi Freedom) veterans are presenting with high rates of PTSD. Translating Initiatives for Depression into Effective Solutions (TIDES) is a model of phone-based care being implemented nationally as a model to address those patients suffering from depression, PTSD, or alcohol use disorders. However, evidence-based treatments do not yet exist for phone-based management of OEF/OIF veterans who suffer from PTSD.
Research Plan:
This is an open trial to assess feasibility of augmenting standard treatment of PTSD with TIDES based telephone-based nurse care management.
Detailed description
Background:
Veterans from Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) present with high rates of post-traumatic stress disorder (PTSD) and depressive disorders, but may experience barriers to specialty mental health (MH) care. Recent research suggests the majority of OEF/OIF veterans referred to MH for PTSD or depression fail to attend the recommended number of appointments within the first year. The TIDES (Translating Initiatives for Depression into Effective Solutions) model of collaborative care management for depression is an evidence-based option for VA primary care settings. However, patients in TIDES care management often have co-morbid PTSD, and the current model does not include PTSD-specific tools.
Objectives:
The primary objectives of the project were to assess feasibility and acceptability of (1) adapting TIDES tools and protocols to include PTSD and depression in the management of OEF/OIF patients, and (2) implementing the adapted model to augment treatment as usual in the VA Seattle-Puget Sound Deployment Health Clinic (DHC).
Methods:
We conducted a pilot implementation of the TIDES/PTSD model in a single site that provides integrated care specifically for OEF/OIF veterans. TIDES CPRS (Computerized Patient Record System) templates were adapted to include assessment and monitoring for PTSD. Phone-based care management protocols were expanded to include PTSD in three clinical domains: (1) medication management, (2) psychosocial support, and (3) patient self-management support, including the optional workbook "Strategies for Managing Stress After the War: Veterans Workbook." The templates were written in VA Class 1 Software, and clinical data were coded as Health Factors, allowing for automatic collection into the VISN 20 Data Warehouse. TIDES Care Managers were trained to use these templates, protocols, and workbook. Clinical staff received an orientation to the model of care. We enrolled 20 patients, newly initiating care at the DHC, who had a clinical diagnosis of PTSD and score of 50 or greater on the PTSD Check List-Military version (PCL-M). Co-morbid depression, if present, was defined by clinical diagnosis and a score of 10 or greater on the nine-item Patient Health Questionnaire (PHQ-9). Patients were followed by a Care Manager for up to six months. Formative evaluation included utilization data, clinical data, and qualitative data from semi-structured interviews of clinical staff and patients on their experiences with the model.
Status:
Final report.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phone Based Outreach Intervention Group | Experimental | Other: Phone-based outreachOpen pilot trial |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PTSD
- Operation Enduring Freedom and Operation Iraqi Freedom veteran
Key exclusion criteria (2 listed)
- no phone
- severe brain injury
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 |
|---|---|---|
| Phone-based outreachNurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD | Other | Phone Based Outreach Intervention Group |
Primary outcome
Acceptability to Providers and Patients
Time frame: Six months
Patients and providers rated the components of the intervention on a 5 point scale where 1 = poor and 5 = excellent and average ratings for each group is reported below
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Post-Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Bradford L. Felker, MD BA principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone-based outreach in people with Post-Traumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site 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 2 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 28 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 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 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?
Acceptability to Providers and Patients (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2015.