Posttraumatic Stress DisorderNCT00908440
Decision Aid in Veterans With Posttraumatic Stress Disorder
A study testing Decision Aid in people with Posttraumatic Stress Disorder, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of a decision aid on veterans with posttraumatic stress disorder (PTSD) presenting for care. The investigators' primary hypothesis is that patients assigned to use the decision aid will demonstrate improved quality of decisions regarding PTSD treatment relative to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jan 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans who meet criteria for Posttraumatic Stress Disorder on the Posttraumatic Stress Disorder Checklist (PCL).
Who cannot join
- Patients must not have active substance abuse.
- Patients must not have received VA PTSD treatment within the last 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
White River Junction VAMC
White River Junction, Vermont, 05009
About this study
The purpose of this study is to examine the effects of a decision aid on veterans with posttraumatic stress disorder (PTSD) presenting for care. The investigators' primary hypothesis is that patients assigned to use the decision aid will demonstrate improved quality of decisions regarding PTSD treatment relative to patients assigned to usual care. Improved decision quality will be examined by assessing patient's knowledge of treatments, evaluation of the risk and benefits, ability to arrive at a decision, and certainty about that decision. The investigators' secondary hypothesis is that patients assigned to the decision aid will be more satisfied with their care and more compliant with their care compared to patients assigned to receive usual care. The investigators will also determine whether patients assigned to the decision aid, relative to patients assigned to usual care, are more likely to receive evidence-based treatments for PTSD and experience reductions in PTSD symptoms.
Read the detailed description
Posttraumatic stress is a severe and often disabling condition affecting millions of veterans. Within VA, significant staffing and financial resources are devoted to the mission of treating PTSD and the anticipated need for treatment is expected to accelerate as veterans return from the Iraq war.
Research has identified a number of successful strategies for the treatment of PTSD, including both psychotherapy and pharmacology. Several treatments, including group psychotherapy and benzodiazepines have demonstrated a lack of efficacy in the treatment of PTSD. Despite this knowledge, many veterans with PTSD do not receive an evidence-based treatment and may even receive a treatment known to not be effective. Among the group of proven effective treatments, the patient time commitment and adverse effects differ considerably. Patients with PTSD are often ill informed about the available treatments, and there has been little formal effort aimed at matching the patients' preferences to a specific treatment.
We propose to conduct a clinical trial of a decision aid for veterans with PTSD. Decision aids are standardized, evidence-based tools to help patients choose between two or more preference-sensitive, clinically acceptable options when there is no clear "best" option. Decision aids are designed to provide patients with detailed balanced information about all the viable treatment options. In addition, they seek to assist the patient in clarifying their own values and preferences such that the patient may choose among the available treatment options.
We believe that the use of a decision aid, compared to treatment as usual, will result in a more patient-centered approach that ultimately will increase the likelihood of the patient receiving evidence based care, both of which are priority goals of VHA.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Decision Aid
- Keywords
- Decision Aid, Posttraumatic Stress Disorder, evidence-based treatments
- 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.
Decision AidBehavioural
25 page booklet informing patients about PTSD symptoms and treatment options
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of treatments, evaluation of the risk and benefits, as assessed by the Knowledge Questionnaire
Measured: 1 week
Ability to arrive at a decision and certainty about that decision, score on the Decisional Conflict Scale
Measured: 1 week
Satisfaction with care and compliance with care, score on the Survey of Health Experiences
Measured: 1 week
Secondary outcomes (1)
Use of evidence based treatments and overall cost
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- White River Junction Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Investigators
- Bradley V Watts, MD, MPH, Principal investigator, White River Junction Veterans Affairs Medical CenterPaula Schnurr, PHD, Principal investigator, White River Junction Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908440
- Sponsor's protocol ID
- IIR 07-266
- Status last verified
- May 2009
- First submitted
- 20 May 2009
- Last updated
- 25 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Foa, E.B., Keane, TM, Friedman, M.J. (eds): Effective treatments for PTSD: Practice guidelines from the International Society for Traumatic Stress Studies. NY, Guilford, 2000.
Watts, B., Mayo, L., Weeks, W. A meta analysis of treatments for posttraumatic stress disorder, in International Society for Traumatic Stress Studies 21st Annual meeting. Toronto, Canada, 2005.
O'Connor AM, Stacey D, Entwistle V, Llewellyn-Thomas H, Rovner D, Holmes-Rovner M, Tait V, Tetroe J, Fiset V, Barry M, Jones J. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2003;(2):CD001431. doi: 10.1002/14651858.CD001431.
PubMed 12804407Rosen CS, Chow HC, Finney JF, Greenbaum MA, Moos RH, Sheikh JI, Yesavage JA. VA practice patterns and practice guidelines for treating posttraumatic stress disorder. J Trauma Stress. 2004 Jun;17(3):213-22. doi: 10.1023/B:JOTS.0000029264.23878.53.
PubMed 15253093Watts BV, Zayed MH, Llewellyn-Thomas H, Schnurr PP. Understanding and meeting information needs for patients with posttraumatic stress disorder. BMC Psychiatry. 2016 Feb 1;16:21. doi: 10.1186/s12888-016-0724-x.
PubMed 26830930
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Aid in Veterans With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00908440
- Acronym / sponsor ID
- IIR 07-266
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Decision Aid, Posttraumatic Stress Disorder, evidence-based treatments
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Study start
- Jun 2009
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 25 May 2009 (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.
The purpose of this study is to examine the effects of a decision aid on veterans with posttraumatic stress disorder (PTSD) presenting for care. The investigators' primary hypothesis is that patients assigned to use the decision aid will demonstrate improved quality of decisions regarding PTSD treatment relative to patients assigned to usual care. Improved decision quality will be examined by assessing patient's knowledge of treatments, evaluation of the risk and benefits, ability to arrive at a decision, and certainty about that decision. The investigators' secondary hypothesis is that patients assigned to the decision aid will be more satisfied with their care and more compliant with their care compared to patients assigned to receive usual care. The investigators will also determine whether patients assigned to the decision aid, relative to patients assigned to usual care, are more likely to receive evidence-based treatments for PTSD and experience reductions in PTSD symptoms.
Detailed description
Posttraumatic stress is a severe and often disabling condition affecting millions of veterans. Within VA, significant staffing and financial resources are devoted to the mission of treating PTSD and the anticipated need for treatment is expected to accelerate as veterans return from the Iraq war.
Research has identified a number of successful strategies for the treatment of PTSD, including both psychotherapy and pharmacology. Several treatments, including group psychotherapy and benzodiazepines have demonstrated a lack of efficacy in the treatment of PTSD. Despite this knowledge, many veterans with PTSD do not receive an evidence-based treatment and may even receive a treatment known to not be effective. Among the group of proven effective treatments, the patient time commitment and adverse effects differ considerably. Patients with PTSD are often ill informed about the available treatments, and there has been little formal effort aimed at matching the patients' preferences to a specific treatment.
We propose to conduct a clinical trial of a decision aid for veterans with PTSD. Decision aids are standardized, evidence-based tools to help patients choose between two or more preference-sensitive, clinically acceptable options when there is no clear "best" option. Decision aids are designed to provide patients with detailed balanced information about all the viable treatment options. In addition, they seek to assist the patient in clarifying their own values and preferences such that the patient may choose among the available treatment options.
We believe that the use of a decision aid, compared to treatment as usual, will result in a more patient-centered approach that ultimately will increase the likelihood of the patient receiving evidence based care, both of which are priority goals of VHA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans who meet criteria for Posttraumatic Stress Disorder on the Posttraumatic Stress Disorder Checklist (PCL).
Key exclusion criteria (2 listed)
- Patients must not have active substance abuse.
- Patients must not have received VA PTSD treatment within the last 12 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 |
|---|---|---|
| Decision Aid25 page booklet informing patients about PTSD symptoms and treatment options | Behavioural | – |
Primary outcome
Knowledge of treatments, evaluation of the risk and benefits, as assessed by the Knowledge Questionnaire
Time frame: 1 week
Ability to arrive at a decision and certainty about that decision, score on the Decisional Conflict Scale
Time frame: 1 week
Satisfaction with care and compliance with care, score on the Survey of Health Experiences
Time frame: 1 week
1 secondary outcome
Use of evidence based treatments and overall cost
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2009.
- BackgroundFoa, E.B., Keane, TM, Friedman, M.J. (eds): Effective treatments for PTSD: Practice guidelines from the International Society for Traumatic Stress Studies. NY, Guilford, 2000.
- BackgroundWatts, B., Mayo, L., Weeks, W. A meta analysis of treatments for posttraumatic stress disorder, in International Society for Traumatic Stress Studies 21st Annual meeting. Toronto, Canada, 2005.
- Background: PubMed 12804407O'Connor AM, Stacey D, Entwistle V, Llewellyn-Thomas H, Rovner D, Holmes-Rovner M, Tait V, Tetroe J, Fiset V, Barry M, Jones J. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2003;(2):CD001431. doi: 10.1002/14651858.CD001431.
- Background: PubMed 15253093Rosen CS, Chow HC, Finney JF, Greenbaum MA, Moos RH, Sheikh JI, Yesavage JA. VA practice patterns and practice guidelines for treating posttraumatic stress disorder. J Trauma Stress. 2004 Jun;17(3):213-22. doi: 10.1023/B:JOTS.0000029264.23878.53.
- Derived from this study: PubMed 26830930Watts BV, Zayed MH, Llewellyn-Thomas H, Schnurr PP. Understanding and meeting information needs for patients with posttraumatic stress disorder. BMC Psychiatry. 2016 Feb 1;16:21. doi: 10.1186/s12888-016-0724-x.
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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.
Bradley V Watts, MD, MPH principal investigator
White River Junction Veterans Affairs Medical Center
Paula Schnurr, PHD principal investigator
White River Junction Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Posttraumatic Stress Disorder, run by White River Junction Veterans Affairs Medical Center 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 1 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: status not confirmed, as of the sponsor's last update on 25 May 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha H Zayed, PHD (802-295-9363 ext. 5918, Maha.Zayed@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of treatments, evaluation of the risk and benefits, as assessed by the Knowledge Questionnaire (time frame: 1 week). The study lists 3 primary outcomes in all. 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 NCT00908440, which also lists 5 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 25 May 2009.