Posttraumatic Stress DisorderNCT02313818
Variable-length Cognitive Processing Therapy for Combat-Related PTSD
A study testing Cognitive Processing Therapy-Cognitive Only in people with Posttraumatic Stress Disorder, run by Duke University at 1 site in United States.
Trial summary
The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment. 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?
- Cognitive Processing Therapy-Cognitive Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2018
- 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
- Adult male and female combat veterans who deployed in support of combat operations following 9/11
- Diagnosis of PTSD determined by a Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
- Speak and read English
Who cannot join
- Current suicide or homicide risk meriting crisis intervention.
- Active psychosis.
- Moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires).
- Local availability of fewer than 5 months
- Late-phase Med Board status, awaiting percentages
- Undergoing a chapter
Trial locations and contacts
1 site in 1 country.
United States1 site
Carl R Darnall Army Medical Center
Fort Hood, Texas, 76544
About this study
The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment.
Read the detailed description
The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment. The study seeks to determine if some service members would benefit from a longer or shorter dose of treatment (4-24 sessions), and to identify which individuals are likely to require more, less, or the standard number of treatment sessions to reach good end-state functioning. Predictors of length of therapy and treatment outcome will be examined. Specifically, we will evaluate factors related to internalizing/externalizing traits, cognitive flexibility, inability to inhibit dysfunctional cognitions, and readiness to change as they are related to the number of treatment sessions required to treat patients to the point of good end-state functioning. Additional outcomes including alcohol use, psychosocial functioning, physical health, and sleep also will be evaluated.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Cognitive Processing Therapy-Cognitive Only
- Keywords
- Posttraumatic Stress Disorder, Cognitive Processing Therapy, Active Duty Military
- 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.
Cognitive Processing Therapy-Cognitive OnlyBehavioural
Cognitive Processing Therapy-Cognitive Only (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Individual sessions will be conducted twice weekly for 4-24 sessions; each session is 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| CPT-C | Experimental | Cognitive Processing Therapy-Cognitive Only (CPT-C) conducted twice weekly for 4-24 sessions based on good end state functioning. Receives: Behavioral: Cognitive Processing Therapy-Cognitive Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5)
PCL-5 measures symptoms of posttraumatic stress disorder in response to a specific stressor.
Measured: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment
Change from baseline in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5)
is an updated version of the gold standard CAPS designed to assess the criteria for PTSD as defined by the DSM-5
Measured: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment
Secondary outcomes (1)
Change from baseline in depressive symptoms as measured by the Patient Health Questionnaire-9
The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms (Kroenke, Spitzer, \& Williams, 2001). It consists of 9 items that assess both affective and somatic symptoms related to depression and depressive disorders; these 9 items correspond to the diagnostic criteria for DSM MDD. Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores on all items are summed to obtain a total severity score.
Measured: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startJun 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Model description
- Variable length Cognitive Processing Therapy
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston VA Research Institute, Inc., The University of Texas Health Science Center at San Antonio, STRONG STAR Consortium
- Responsible party
- Sponsor
- Investigators
- Patricia A Resick, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313818
- Sponsor's protocol ID
- Pro00062853
- Other IDs
- W81XWH-13-2-0012
- Status last verified
- Dec 2018
- First submitted
- 8 Dec 2014
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hass NC, Wachen JS, Straud CL, Checko E, McGeary DD, McGeary CA, Mintz J, Litz BT, Young-McCaughan S, Yarvis JS, Peterson AL, Resick PA; STRONG STAR Consortium. Changes in pain and related health outcomes after cognitive processing therapy in an active duty military sample. J Trauma Stress. 2025 Jun;38(3):447-457. doi: 10.1002/jts.23143. Epub 2025 Mar 5.
PubMed 40045687Foa EB, Zandberg LJ, McLean CP, Rosenfield D, Fitzgerald H, Tuerk PW, Wangelin BC, Young-McCaughan S, Peterson AL. The efficacy of 90-minute versus 60-minute sessions of prolonged exposure for posttraumatic stress disorder: Design of a randomized controlled trial in active duty military personnel. Psychol Trauma. 2019 Mar;11(3):307-313. doi: 10.1037/tra0000351. Epub 2018 Feb 12.
PubMed 29431455
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variable-length Cognitive Processing Therapy for Combat-Related PTSD
- ClinicalTrials.gov ID
- NCT02313818
- Acronym / sponsor ID
- Pro00062853
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, Cognitive Processing Therapy, Active Duty Military
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Boston VA Research Institute, Inc., The University of Texas Health Science Center at San Antonio, STRONG STAR Consortium
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Dec 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.
The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment.
Detailed description
The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment. The study seeks to determine if some service members would benefit from a longer or shorter dose of treatment (4-24 sessions), and to identify which individuals are likely to require more, less, or the standard number of treatment sessions to reach good end-state functioning. Predictors of length of therapy and treatment outcome will be examined. Specifically, we will evaluate factors related to internalizing/externalizing traits, cognitive flexibility, inability to inhibit dysfunctional cognitions, and readiness to change as they are related to the number of treatment sessions required to treat patients to the point of good end-state functioning. Additional outcomes including alcohol use, psychosocial functioning, physical health, and sleep also will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Variable length Cognitive Processing Therapy
| Arm | Type | Receives |
|---|---|---|
| CPT-C | Experimental | Behavioral: Cognitive Processing Therapy-Cognitive OnlyCognitive Processing Therapy-Cognitive Only (CPT-C) conducted twice weekly for 4-24 sessions based on good end state functioning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male and female combat veterans who deployed in support of combat operations following 9/11
- Diagnosis of PTSD determined by a Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
- Speak and read English
Key exclusion criteria (6 listed)
- Current suicide or homicide risk meriting crisis intervention.
- Active psychosis.
- Moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires).
- Local availability of fewer than 5 months
- Late-phase Med Board status, awaiting percentages
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 Processing Therapy-Cognitive OnlyCognitive Processing Therapy-Cognitive Only (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Individual sessions will be conducted twice weekly for 4-24 sessions; each session is 60 minutes. | Behavioural | CPT-C |
Primary outcome
Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5)
Time frame: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment
PCL-5 measures symptoms of posttraumatic stress disorder in response to a specific stressor.
Change from baseline in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5)
Time frame: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment
is an updated version of the gold standard CAPS designed to assess the criteria for PTSD as defined by the DSM-5
1 secondary outcome
Change from baseline in depressive symptoms as measured by the Patient Health Questionnaire-9
Time frame: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment
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 16 Jan 2019.
- Derived from this study: PubMed 40045687Hass NC, Wachen JS, Straud CL, Checko E, McGeary DD, McGeary CA, Mintz J, Litz BT, Young-McCaughan S, Yarvis JS, Peterson AL, Resick PA; STRONG STAR Consortium. Changes in pain and related health outcomes after cognitive processing therapy in an active duty military sample. J Trauma Stress. 2025 Jun;38(3):447-457. doi: 10.1002/jts.23143. Epub 2025 Mar 5.
- Derived from this study: PubMed 29431455Foa EB, Zandberg LJ, McLean CP, Rosenfield D, Fitzgerald H, Tuerk PW, Wangelin BC, Young-McCaughan S, Peterson AL. The efficacy of 90-minute versus 60-minute sessions of prolonged exposure for posttraumatic stress disorder: Design of a randomized controlled trial in active duty military personnel. Psychol Trauma. 2019 Mar;11(3):307-313. doi: 10.1037/tra0000351. Epub 2018 Feb 12.
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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.
Patricia A Resick, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy-Cognitive Only in people with Posttraumatic Stress Disorder, run by Duke University 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 6 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 16 Jan 2019. 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?
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?
Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5) (time frame: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment). 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 NCT02313818, which also lists 2 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 16 Jan 2019.