Post-Traumatic Stress DisorderNCT02290639
Brief Cognitive Behavioral Treatment of Deployment-Related PTSD Symptoms in Primary Care Settings
A study testing Brief Cognitive Behavioral Treatment and Minimal Contact in people with Post-Traumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
A significant number of veterans of the wars in Iraq and Afghanistan are affected by posttraumatic stress disorder (PTSD). The limited reach of effective treatments for PTSD into the veteran population is at least partially due to the perceived stigma by service members for seeking help in traditional specialty mental… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Brief Cognitive Behavioral Treatment and Minimal Contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to Nov 2015
- 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
- active duty, reserve, guard, separated, or retired OIF/OEF/OND veterans seeking care in primary care for deployment-related PTSD symptoms
- Symptomatic for PTSD will be defined as a minimum score of 32 on the PTSD CheckList -Stressor-specific (PCL-S)
- English speaking
- If individuals are taking psychotropic medication, a 4-week stabilization period may be required prior to enrollment, depending upon the medication, half-life, and anticipated interaction with the ability to engage in behavioral therapy
Who cannot join
- moderate to severe suicide risk
- current alcohol dependence, psychotic disorder, significant dissociative disorder
- severe brain injury
- Patients who are currently receiving talk therapy for trauma-related symptoms will also be excluded
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wilford Hall Ambulatory Surgical Center Family Medicine Clinic
Lackland Air Force Base, Texas, 78236
Joint Base San Antonio
Randolph Air Force Base, Texas, 78148
About this study
Official title: Brief Cognitive Behavioral Treatment of Deployment-Related PTSD Symptoms in Primary Care Settings: A Randomized Controlled Trial
A significant number of veterans of the wars in Iraq and Afghanistan are affected by posttraumatic stress disorder (PTSD). The limited reach of effective treatments for PTSD into the veteran population is at least partially due to the perceived stigma by service members for seeking help in traditional specialty mental health clinics. A comprehensive approach to PTSD treatment in a veteran population should provide alternative sources for accessing effective psychotherapy treatments. The purpose of study is to conduct a randomized clinical trial comparing a brief (four 30-minute sessions delivered over 6 weeks) cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants working in an integrated primary care setting to a minimal contact 6-week control. The primary outcome measure is PTSD symptom relief.
Read the detailed description
A significant number of veterans of the wars in Iraq and Afghanistan are affected by posttraumatic stress disorder (PTSD) yet relatively few are receiving evidence-based treatments (Tanielian, Jaycox, Schell, Marshall, Burnham, Eibner, et al. 2008). The limited reach of effective treatments for PTSD into the veteran population is at least partially due to the perceived stigma by service members for seeking help in traditional specialty mental health clinics (Hoge, Castro, Messer, McGurk, Cotting, \& Koffman, 2004). A comprehensive approach to PTSD treatment in a veteran population should provide alternative sources for accessing effective psychotherapy treatments. This study builds upon a pilot study conducted at Brooke Army Medical Center and the Wilford Hall Medical Center (now the Wilford Hall Ambulatory Surgical Center) (C.2009.022, IRBNet 363516). Using the treatment protocol developed and found to be effective as part of this pilot, the purpose of study is to conduct a randomized clinical trial comparing a brief (four 30-minute sessions delivered over 6 weeks) cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants working in an integrated primary care setting to a minimal contact 6-week control. Up to 75 Service Members with deployment-related PTSD symptoms will be consented, enrolled, and treated until treatment has been completed for 60. The primary outcome measure is PTSD symptom relief.
OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS:
- Will Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn (OIF/OEF/OND) veterans with PTSD symptoms accept an offer of cognitive behavioral therapy (CBT) treatment in the primary care setting versus a referral to specialty care?
- Will a brief (four 30-minute appointments) CBT protocol designed for use by behavioral health consultants working in primary care significantly reduce PTSD symptom severity in OIF/OEF/OND veterans in comparison to a minimal contact condition?
- Are there characteristics of patients at pre-treatment, e.g., demographic variables, level of co-morbid depression, that predict a relatively better or worse response to PTSD treatment in primary care?
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Brief Cognitive Behavioral Treatment, Minimal Contact
- Keywords
- Posttraumatic Stress, Posttraumatic Stress Disorder, Military, Primary Care, Cognitive Behavioral Therapy, Prolonged Exposure, Cognitive Processing Therapy, Behavioral Health Optimization Program, Behavioral Health Consultant
- 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.
Brief Cognitive Behavioral TreatmentBehavioural
Cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants (BHC) working in an integrated primary care setting. The treatment will be provided by a BHC in four 30-minute appointments scheduled approximately once a week in primary care over a one month period. Treatment content was largely drawn from a Prolonged Exposure model, but also includes elements of Cognitive Processing Therapy.
Minimal ContactBehavioural
Participants assigned to minimal contact (MC) will be asked to not work with another therapist or seek additional treatment for trauma-related difficulties during the 6-week MC period. They will be called once per week by the Behavioral Health Consultant (BHC) in order to monitor their status and to provide support as needed. The calls will be limited to 5-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | Four 30-minute sessions of Brief Cognitive Behavioral treatment starting immediately upon randomization. Receives: Behavioral: Brief Cognitive Behavioral Treatment |
| Minimal Contact followed by treatment | Active comparator | 6-week Minimal Contact period consisting of weekly phone calls starting immediately upon randomization. Experimental treatment will be provided to all subjects upon completion of Minimal Contact period. Receives: Behavioral: Brief Cognitive Behavioral Treatment; Behavioral: Minimal Contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptom Scale, Interview Version (PSS-I); to assess change in PTSD symptomatology and/or diagnosis from baseline to multiple follow up time points
The PSS-I is a 20-minute, 17-item clinical interview that evaluates each of the DSM-IV PTSD symptoms during the past 2 weeks on a frequency/severity scale (Foa, Riggs, Dancu, \& Rothbaum, 1993). The PSS-I is comparable to the gold standard employed in studies of veterans (the Clinician Administered PTSD Scale; CAPS) yet takes considerably less time to administer (Foa \& Tolin, 2000). Each symptom is rated on a 4-point scale ranging from 0 (not at all) to 3 (very much). Subscale scores are calculated by summing items in each of the PTSD symptom clusters: re-experiencing, avoidance, and arousal. The scale has excellent internal consistency (α = .85), test-retest reliability (.80), and inter-rater reliability (kappa = .97; Foa et al, 1993). This measure will be administered by a blinded Independent Evaluator at each study site.
Measured: Baseline, 2 weeks post-tx, 8 weeks post-tx, 6 months post-tx
PTSD Checklist - Stressor-Specific Version (PCL-S); to assess change in PTSD symptomatology from baseline throughout treatment and at multiple follow up time points
The PCL-S is a 17 item self-report measure based upon the PTSD Checklist - Military (PCL-M; Weathers, Litz, Herman, Huska, \& Keane, 1993) that evaluates how much participants have been bothered by PTSD symptoms in the past month as a result of the stressful life events identified by either the participant, or by the Independent Evaluator following administration of the PSS-I. Each item of the PCL-S is scored on a five-point scale ranging from 1 (-not at all‖) to 5 (-extremely‖). The measure is divided into 3 subscales: Re-experiencing symptoms (items 1- 5); Avoidance/ Emotional Numbing symptoms (items 6- 12); and Hyper-arousal symptoms (items 12-17).
Measured: Baseline, Weekly during treatment (4 time points), 2 weeks post-tx, 8 weeks post-tx, 6 months post-tx
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startDec 2012
- Primary completionMar 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- San Antonio Military Medical Center, 59th Medical Wing, Wright State University
- Responsible party
- Sponsor
- Investigators
- Alan L Peterson, PhD, ABPP, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290639
- Sponsor's protocol ID
- HSC20130057H
- Other IDs
- C.2012.184d, W81XWH-08-2-0109
- Status last verified
- Jan 2016
- First submitted
- 7 Nov 2014
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cigrang JA, Rauch SA, Mintz J, Brundige AR, Mitchell JA, Najera E, Litz BT, Young-McCaughan S, Roache JD, Hembree EA, Goodie JL, Sonnek SM, Peterson AL; STRONG STAR Consortium. Moving effective treatment for posttraumatic stress disorder to primary care: A randomized controlled trial with active duty military. Fam Syst Health. 2017 Dec;35(4):450-462. doi: 10.1037/fsh0000315.
PubMed 29283612
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Cognitive Behavioral Treatment of Deployment-Related PTSD Symptoms in Primary Care Settings: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02290639
- Acronym / sponsor ID
- HSC20130057H
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Posttraumatic Stress, Posttraumatic Stress Disorder, Military, Primary Care, Cognitive Behavioral Therapy, Prolonged Exposure, Cognitive Processing Therapy, Behavioral Health Optimization Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- San Antonio Military Medical Center, 59th Medical Wing, Wright State University
- Study start
- Dec 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Nov 2014 (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.
A significant number of veterans of the wars in Iraq and Afghanistan are affected by posttraumatic stress disorder (PTSD). The limited reach of effective treatments for PTSD into the veteran population is at least partially due to the perceived stigma by service members for seeking help in traditional specialty mental health clinics. A comprehensive approach to PTSD treatment in a veteran population should provide alternative sources for accessing effective psychotherapy treatments. The purpose of study is to conduct a randomized clinical trial comparing a brief (four 30-minute sessions delivered over 6 weeks) cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants working in an integrated primary care setting to a minimal contact 6-week control. The primary outcome measure is PTSD symptom relief.
Detailed description
A significant number of veterans of the wars in Iraq and Afghanistan are affected by posttraumatic stress disorder (PTSD) yet relatively few are receiving evidence-based treatments (Tanielian, Jaycox, Schell, Marshall, Burnham, Eibner, et al. 2008). The limited reach of effective treatments for PTSD into the veteran population is at least partially due to the perceived stigma by service members for seeking help in traditional specialty mental health clinics (Hoge, Castro, Messer, McGurk, Cotting, \& Koffman, 2004). A comprehensive approach to PTSD treatment in a veteran population should provide alternative sources for accessing effective psychotherapy treatments. This study builds upon a pilot study conducted at Brooke Army Medical Center and the Wilford Hall Medical Center (now the Wilford Hall Ambulatory Surgical Center) (C.2009.022, IRBNet 363516). Using the treatment protocol developed and found to be effective as part of this pilot, the purpose of study is to conduct a randomized clinical trial comparing a brief (four 30-minute sessions delivered over 6 weeks) cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants working in an integrated primary care setting to a minimal contact 6-week control. Up to 75 Service Members with deployment-related PTSD symptoms will be consented, enrolled, and treated until treatment has been completed for 60. The primary outcome measure is PTSD symptom relief.
OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS:
- Will Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn (OIF/OEF/OND) veterans with PTSD symptoms accept an offer of cognitive behavioral therapy (CBT) treatment in the primary care setting versus a referral to specialty care?
- Will a brief (four 30-minute appointments) CBT protocol designed for use by behavioral health consultants working in primary care significantly reduce PTSD symptom severity in OIF/OEF/OND veterans in comparison to a minimal contact condition?
- Are there characteristics of patients at pre-treatment, e.g., demographic variables, level of co-morbid depression, that predict a relatively better or worse response to PTSD treatment in primary care?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: Brief Cognitive Behavioral TreatmentFour 30-minute sessions of Brief Cognitive Behavioral treatment starting immediately upon randomization. |
| Minimal Contact followed by treatment | Active comparator | Behavioral: Brief Cognitive Behavioral Treatment, Behavioral: Minimal Contact6-week Minimal Contact period consisting of weekly phone calls starting immediately upon randomization. Experimental treatment will be provided to all subjects upon completion of Minimal Contact period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- active duty, reserve, guard, separated, or retired OIF/OEF/OND veterans seeking care in primary care for deployment-related PTSD symptoms
- Symptomatic for PTSD will be defined as a minimum score of 32 on the PTSD CheckList -Stressor-specific (PCL-S)
- English speaking
- If individuals are taking psychotropic medication, a 4-week stabilization period may be required prior to enrollment, depending upon the medication, half-life, and anticipated interaction with the ability to engage in behavioral therapy
Key exclusion criteria (4 listed)
- moderate to severe suicide risk
- current alcohol dependence, psychotic disorder, significant dissociative disorder
- severe brain injury
- Patients who are currently receiving talk therapy for trauma-related symptoms will also be excluded
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 |
|---|---|---|
| Brief Cognitive Behavioral TreatmentCognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants (BHC) working in an integrated primary care setting. The treatment will be provided by a BHC in four 30-minute appointments scheduled approximately once a week in primary care over a one month period. Treatment content was largely drawn from a Prolonged Exposure model, but also includes elements of Cognitive Processing Therapy. | Behavioural | Immediate Treatment, Minimal Contact followed by treatment |
| Minimal ContactParticipants assigned to minimal contact (MC) will be asked to not work with another therapist or seek additional treatment for trauma-related difficulties during the 6-week MC period. They will be called once per week by the Behavioral Health Consultant (BHC) in order to monitor their status and to provide support as needed. The calls will be limited to 5-10 minutes. | Behavioural | Minimal Contact followed by treatment |
Primary outcome
PTSD Symptom Scale, Interview Version (PSS-I); to assess change in PTSD symptomatology and/or diagnosis from baseline to multiple follow up time points
Time frame: Baseline, 2 weeks post-tx, 8 weeks post-tx, 6 months post-tx
The PSS-I is a 20-minute, 17-item clinical interview that evaluates each of the DSM-IV PTSD symptoms during the past 2 weeks on a frequency/severity scale (Foa, Riggs, Dancu, \& Rothbaum, 1993). The PSS-I is comparable to the gold standard employed in studies of veterans (the Clinician Administered PTSD Scale; CAPS) yet takes considerably less time to administer (Foa \& Tolin, 2000). Each symptom is rated on a 4-point scale ranging from 0 (not at all) to 3 (very much). Subscale scores are calculated by summing items in each of the PTSD symptom clusters: re-experiencing, avoidance, and arousal. The scale has excellent internal consistency (α = .85), test-retest reliability (.80), and inter-rater reliability (kappa = .97; Foa et al, 1993). This measure will be administered by a blinded Independent Evaluator at each study site.
PTSD Checklist - Stressor-Specific Version (PCL-S); to assess change in PTSD symptomatology from baseline throughout treatment and at multiple follow up time points
Time frame: Baseline, Weekly during treatment (4 time points), 2 weeks post-tx, 8 weeks post-tx, 6 months post-tx
The PCL-S is a 17 item self-report measure based upon the PTSD Checklist - Military (PCL-M; Weathers, Litz, Herman, Huska, \& Keane, 1993) that evaluates how much participants have been bothered by PTSD symptoms in the past month as a result of the stressful life events identified by either the participant, or by the Independent Evaluator following administration of the PSS-I. Each item of the PCL-S is scored on a five-point scale ranging from 1 (-not at all‖) to 5 (-extremely‖). The measure is divided into 3 subscales: Re-experiencing symptoms (items 1- 5); Avoidance/ Emotional Numbing symptoms (items 6- 12); and Hyper-arousal symptoms (items 12-17).
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 12 Jan 2016.
- Derived from this study: PubMed 29283612Cigrang JA, Rauch SA, Mintz J, Brundige AR, Mitchell JA, Najera E, Litz BT, Young-McCaughan S, Roache JD, Hembree EA, Goodie JL, Sonnek SM, Peterson AL; STRONG STAR Consortium. Moving effective treatment for posttraumatic stress disorder to primary care: A randomized controlled trial with active duty military. Fam Syst Health. 2017 Dec;35(4):450-462. doi: 10.1037/fsh0000315.
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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, ABPP principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Cognitive Behavioral Treatment and Minimal Contact in people with Post-Traumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio at 2 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 4 inclusion and 4 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 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Symptom Scale, Interview Version (PSS-I); to assess change in PTSD symptomatology and/or diagnosis from baseline to multiple follow up time points (time frame: Baseline, 2 weeks post-tx, 8 weeks post-tx, 6 months post-tx). The study lists 2 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 NCT02290639, 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 12 Jan 2016.