Posttraumatic Stress Disorder (PTSD)NCT01446146
Increasing Engagement in PTSD Treatment Through Patient Education and Patient Choice
A study testing Informed decision making in people with Posttraumatic Stress Disorder (PTSD), run by Michael E. DeBakey VA Medical Center at 1 site in United States.
Trial summary
The purpose of this program is to compare two different methods of matching a Veteran to a 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?
- Informed decision making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jan 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of combat-related PTSD
- Newly enrolled in Trauma Recovery Program (TRP) at the Michael E. DeBakey VA medical center
- TRP provider approval
Who cannot join
- Previous participation in TRP treatment for PTSD
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
About this study
The purpose of this program is to compare two different methods of matching a Veteran to a PTSD treatment.
Read the detailed description
Posttraumatic Stress Disorder (PTSD) is a serious disorder that affects many Veterans who have had a traumatic experience. The VA offers several different types of treatment for PTSD. We are researching different ways to match a Veteran to a type of treatment. Participants in this study will will be randomly assigned to either a 40-minute session in which they will learn about PTSD treatments and select a preferred treatment or to a 40-minute assessment interview. Those participants assigned to the assessment interview will have the opportunity to work with their Trauma Recovery Program provider to determine a plan for their PTSD treatment.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Informed decision making, Placebo session
- Keywords
- Posttraumatic Stress Disorder, PTSD Treatment, Decision making, Veterans
- 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.
Informed decision makingBehavioural
40 minute session with a clinician. Participants will learn about the available PTSD treatment options and will be given a decision aid with more information.
Placebo sessionBehavioural
Participant will complete clinician-administered measures in a 40-minute session.
| Study group | Role | What they receive |
|---|---|---|
| IDM intervention | Experimental | Will receive a 40 minute intervention session with a clinician, learning about PTSD treatment options and choosing a preferred treatment. Receives: Behavioral: Informed decision making |
| Treatment as usual plus placebo session | Placebo comparator | Will work with provider to select a treatment plan and will receive a 40 minute session without IDM intervention. Receives: Behavioral: Placebo session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment participation
Trauma Recovery Program service utilization as assessed by chart review.
Measured: 4 months
Secondary outcomes (2)
Treatment satisfaction
Assessed via self-report measures (Client Satisfaction Questionnaire, Credibility/Expectancy Questionnaire) and semi-structured interview
Measured: 4 months
Change in PTSD severity
Assessed by the PCL-M at baseline and 4 month follow-up
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael E. DeBakey VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- South Central VA Mental Illness Research, Education & Clinical Center
- Responsible party
- Principal investigator, Juliette Mott, Michael E. DeBakey VA Medical Center
- Investigators
- Juliette M Mott, PhD, Principal investigator, MDVAMC, BCM, SC MIRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446146
- Sponsor's protocol ID
- H-28111
- Status last verified
- Jul 2013
- First submitted
- 28 Sep 2011
- Last updated
- 24 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Engagement in PTSD Treatment Through Patient Education and Patient Choice
- ClinicalTrials.gov ID
- NCT01446146
- Acronym / sponsor ID
- H-28111
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- Posttraumatic Stress Disorder, PTSD Treatment, Decision making, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Michael E. DeBakey VA Medical CenterUS federal agency
- Collaborators
- South Central VA Mental Illness Research, Education & Clinical Center
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Oct 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.
The purpose of this program is to compare two different methods of matching a Veteran to a PTSD treatment.
Detailed description
Posttraumatic Stress Disorder (PTSD) is a serious disorder that affects many Veterans who have had a traumatic experience. The VA offers several different types of treatment for PTSD. We are researching different ways to match a Veteran to a type of treatment. Participants in this study will will be randomly assigned to either a 40-minute session in which they will learn about PTSD treatments and select a preferred treatment or to a 40-minute assessment interview. Those participants assigned to the assessment interview will have the opportunity to work with their Trauma Recovery Program provider to determine a plan for their PTSD treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDM intervention | Experimental | Behavioral: Informed decision makingWill receive a 40 minute intervention session with a clinician, learning about PTSD treatment options and choosing a preferred treatment. |
| Treatment as usual plus placebo session | Placebo comparator | Behavioral: Placebo sessionWill work with provider to select a treatment plan and will receive a 40 minute session without IDM intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of combat-related PTSD
- Newly enrolled in Trauma Recovery Program (TRP) at the Michael E. DeBakey VA medical center
- TRP provider approval
Key exclusion criteria (1 listed)
- Previous participation in TRP treatment for PTSD
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 |
|---|---|---|
| Informed decision making40 minute session with a clinician. Participants will learn about the available PTSD treatment options and will be given a decision aid with more information. | Behavioural | IDM intervention |
| Placebo sessionParticipant will complete clinician-administered measures in a 40-minute session. | Behavioural | Treatment as usual plus placebo session |
Primary outcome
Treatment participation
Time frame: 4 months
Trauma Recovery Program service utilization as assessed by chart review.
2 secondary outcomes
Treatment satisfaction
Time frame: 4 months
Change in PTSD severity
Time frame: Baseline and 4 months
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 24 Jul 2013.
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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.
Juliette M Mott, PhD principal investigator
MDVAMC, BCM, SC MIRECC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informed decision making in people with Posttraumatic Stress Disorder (PTSD), run by Michael E. DeBakey VA 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 3 inclusion and 1 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 Jul 2013. 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. Some participants in this study may receive a placebo. 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?
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?
Treatment participation (time frame: 4 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 24 Jul 2013.