Post-Traumatic Stress DisordersNCT00974402
Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings
A study testing Cognitive Behavioral Therapy in people with Post-Traumatic Stress Disorders and Stress Disorders, run by The University of Texas Health Science Center at San Antonio at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate Cognitive-behavioral therapy (CBT) for deployment-related post-traumatic stress disorder (PTSD) that can be used by behavioral health consultants working with Service Members in the primary care clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorders, Stress Disorders, Combat Disorders
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2008to Jun 2012
- 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
- The target population for the study is active duty, reserve, guard, separated, or retired OIF/OEF veterans (minimum age 18 and English speaking) in the primary care population who are symptomatic for deployment-related PTSD and interested in treatment.
- Symptomatic for PTSD will be defined as a minimum score of 32 on the PTSD CheckList - Military (PCL-M).
Who cannot join
- The exclusion criteria are those that would normally apply for standard of care behavioral health consultation in an integrated primary care clinic.
- These exclusion criteria are moderate to severe suicide risk, current alcohol dependence, psychotic disorder, significant dissociative disorder, and severe brain injury.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
South Texas Veterans Health Care System (STVHCS)
San Antonio, Texas, 78229
Brooke Army Medical Center (BAMC)
San Antonio, Texas, 78234-6200
Wilford Hall Medical Center
San Antonio, Texas, 78236-5300
About this study
Official title: Psychotherapy Treatment of Deployment-related PTSD in Primary Care Settings
The purpose of this study is to evaluate Cognitive-behavioral therapy (CBT) for deployment-related post-traumatic stress disorder (PTSD) that can be used by behavioral health consultants working with Service Members in the primary care clinic. CBT is a well-researched, very effective individual (one-to-one) treatment that is designed to help people to directly deal with traumatic events they have suffered in the past, including combat. Many Service Members prefer to see behavioral health providers in primary care rather than the mental health clinic. The researchers hope to learn if a brief treatment for PTSD in primary care can be just as useful as more traditional treatment given in the mental health clinic. This study will enroll approximately 45 participants overall; with approximately 30 participants at Wilford Hall Medical Center or Brooke Army Medical Center, and 15 participants to be enrolled at the South Texas Veterans Health Care System over a period of one year.
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Active duty, Afghanistan, Anger, Anxiety, Avoidance, BAMC, Brooke Army Medical Center, Cognitive Behavioral Therapy, Combat, Combat Disorder, Coping, Counseling, Counselor, Deployment, Depression, Exposure, Fear, Feeling alone, Flashbacks, Guard
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Combat Disorders, Anxiety Disorders, Depression, Psychological Well-Being, Neurotic Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called brief cognitive-behavioral therapy (CBT)
The study investigators have developed a 4-session PTSD treatment plan including a behavioral health consultants (BHC) manual and a patient guide for use in primary care. Therapists will be psychologists who are functioning as behavioral health consultants (BHC) in an integrated primary care clinic. The study will adapt intervention methods for use in the time-constrained primary care environment from Cognitive Behavioral Therapy(ies) that have proven effective for PTSD in specialty mental health care settings. Study participants will receive four 30-minute treatment sessions over six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Patients with PTSD Symptoms | Experimental | Patients with Post-Traumatic Stress Disorder (PTSD) symptoms willing to undergo Cognitive Behavioral Therapy in a primary care setting. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptomatology
PTSD symptoms as assessed by an evaluator-administered interview (PTSD Symptom Scale Interview - PSSI) and self-report form (PTSD Checklist - Military Version - PCL-M).
Measured: Baseline, post-treatment, 6-month and 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startMar 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisordersStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Brooke Army Medical Center, 59th Medical Wing, South Texas Veterans Health Care System
- Responsible party
- Sponsor
- Investigators
- Alan L Peterson, PhD, Study chair, University of Texas Health Science Center San Antonio (UTHSCSA), STRONG STAR Consortium DirectorJeffrey Cigrang, Lt Col, Principal investigator, U.S. Air Force, 5MDG, Minot Air Force BaseLisa Kearney, PhD, Principal investigator, South Texas Veterans Health Care System (STVHCS)Diana Dolan, Capt, Principal investigator, U.S. Air Force, Wilford Hall Medical Center (WHMC)Laura Avila, PhD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974402
- Sponsor's protocol ID
- HSC20090194H
- Other IDs
- BAMC C.2009.022, W81XWH-08-2-0109
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2009
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapy Treatment of Deployment-related PTSD in Primary Care Settings
- ClinicalTrials.gov ID
- NCT00974402
- Acronym / sponsor ID
- HSC20090194H
- Keywords
- Active duty, Afghanistan, Anger, Anxiety, Avoidance, BAMC, Brooke Army Medical Center, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Brooke Army Medical Center, 59th Medical Wing, South Texas Veterans Health Care System
- Study start
- Mar 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Sep 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 evaluate Cognitive-behavioral therapy (CBT) for deployment-related post-traumatic stress disorder (PTSD) that can be used by behavioral health consultants working with Service Members in the primary care clinic. CBT is a well-researched, very effective individual (one-to-one) treatment that is designed to help people to directly deal with traumatic events they have suffered in the past, including combat. Many Service Members prefer to see behavioral health providers in primary care rather than the mental health clinic. The researchers hope to learn if a brief treatment for PTSD in primary care can be just as useful as more traditional treatment given in the mental health clinic. This study will enroll approximately 45 participants overall; with approximately 30 participants at Wilford Hall Medical Center or Brooke Army Medical Center, and 15 participants to be enrolled at the South Texas Veterans Health Care System over a period of one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PTSD Symptoms | Experimental | Behavioral: Cognitive Behavioral TherapyPatients with Post-Traumatic Stress Disorder (PTSD) symptoms willing to undergo Cognitive Behavioral Therapy in a primary care setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The target population for the study is active duty, reserve, guard, separated, or retired OIF/OEF veterans (minimum age 18 and English speaking) in the primary care population who are symptomatic for deployment-related PTSD and interested in treatment.
- Symptomatic for PTSD will be defined as a minimum score of 32 on the PTSD CheckList - Military (PCL-M).
Key exclusion criteria (2 listed)
- The exclusion criteria are those that would normally apply for standard of care behavioral health consultation in an integrated primary care clinic.
- These exclusion criteria are moderate to severe suicide risk, current alcohol dependence, psychotic disorder, significant dissociative disorder, and 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 |
|---|---|---|
| Cognitive Behavioral TherapyAlso: brief cognitive-behavioral therapy (CBT)The study investigators have developed a 4-session PTSD treatment plan including a behavioral health consultants (BHC) manual and a patient guide for use in primary care. Therapists will be psychologists who are functioning as behavioral health consultants (BHC) in an integrated primary care clinic. The study will adapt intervention methods for use in the time-constrained primary care environment from Cognitive Behavioral Therapy(ies) that have proven effective for PTSD in specialty mental health care settings. Study participants will receive four 30-minute treatment sessions over six weeks. | Behavioural | Patients with PTSD Symptoms |
Primary outcome
PTSD symptomatology
Time frame: Baseline, post-treatment, 6-month and 12-month
PTSD symptoms as assessed by an evaluator-administered interview (PTSD Symptom Scale Interview - PSSI) and self-report form (PTSD Checklist - Military Version - PCL-M).
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 18 Sep 2014.
- Related InfoLink provided by the sponsor.
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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.
Alan L Peterson, PhD study chair
University of Texas Health Science Center San Antonio (UTHSCSA), STRONG STAR Consortium Director
Jeffrey Cigrang, Lt Col principal investigator
U.S. Air Force, 5MDG, Minot Air Force Base
Lisa Kearney, PhD principal investigator
South Texas Veterans Health Care System (STVHCS)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Post-Traumatic Stress Disorders and Stress Disorders, run by The University of Texas Health Science Center at San Antonio at 3 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 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 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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 symptomatology (time frame: Baseline, post-treatment, 6-month and 12-month). 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 18 Sep 2014.