PTSD With a History of Mild to Moderate TBINCT01943162
Enhanced Cognitive Rehabilitation to Treat Comorbid TBI and PTSD
A study testing CPT in people with PTSD With a History of Mild to Moderate TBI, run by San Diego Veterans Healthcare System at 1 site in United States.
Trial summary
This study will test a modification of Cognitive Processing Therapy (CPT) for Post-Traumatic Stress Disorder, (PTSD) in which CPT is augmented with compensatory cognitive rehabilitation principles from the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) intervention to create a hybrid treatment… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- PTSD With a History of Mild to Moderate TBI
- What is being tested?
- CPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Sep 2017
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) OEF/OIF veteran; 2) Current diagnosis of PTSD; 3) History of mild-to-moderate TBI; 4) Subjective cognitive complaints; 5) No anticipated/pending medication changes; 6) Written informed consent to participate in the study. -
- Exclusion Criteria:1) Active substance dependence, 2) Suicidal intent or attempt within the previous month; 3) Current psychotic disorder; 4) Dementia; 5) Non-English speaking; 6) Participation in other intervention studies.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
This study will test a modification of Cognitive Processing Therapy (CPT) for Post-Traumatic Stress Disorder, (PTSD) in which CPT is augmented with compensatory cognitive rehabilitation principles from the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) intervention to create a hybrid treatment, SMART-CPT. This study investigates the efficacy of SMART-CPT in improving PTSD and post-concussive symptoms, cognition, quality of life, and treatment compliance in those with a history of mild to moderate TBI and persistent cognitive complaints.
- Being tested
- CPT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPTBehavioural
| Study group | Role | What they receive |
|---|---|---|
| SMART-CPT | Experimental | CPT with additional elements of cognitive rehabilitation Receives: Behavioral: CPT |
| CPT | Active comparator | Standard Cognitive Processing Therapy Receives: Behavioral: CPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist
Measured: change from baseline PTSD Checklist at 12 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startAug 2012
- Primary completionSep 2017
- Study completionSep 2017
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 PTSD With a History of Mild to Moderate TBIStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego Veterans Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Amy Jak, San Diego Veterans Healthcare System
- Investigators
- Amy Jak, Ph.D., Principal investigator, VA San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943162
- Sponsor's protocol ID
- W81XWH-11-1-0641
- Status last verified
- May 2018
- First submitted
- 6 Sep 2013
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Crocker LD, Sullan MJ, Jurick SM, Thomas KR, Davey DK, Hoffman SN, Twamley EW, Jak AJ. Baseline executive functioning moderates treatment-related changes in quality of life in veterans with posttraumatic stress disorder and comorbid traumatic brain injury. J Trauma Stress. 2023 Feb;36(1):94-105. doi: 10.1002/jts.22883. Epub 2022 Oct 6.
PubMed 36204974
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Cognitive Rehabilitation to Treat Comorbid TBI and PTSD
- ClinicalTrials.gov ID
- NCT01943162
- Acronym / sponsor ID
- W81XWH-11-1-0641
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- San Diego Veterans Healthcare SystemUS federal agency
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- Aug 2012
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 16 Sep 2013 (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.
This study will test a modification of Cognitive Processing Therapy (CPT) for Post-Traumatic Stress Disorder, (PTSD) in which CPT is augmented with compensatory cognitive rehabilitation principles from the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) intervention to create a hybrid treatment, SMART-CPT. This study investigates the efficacy of SMART-CPT in improving PTSD and post-concussive symptoms, cognition, quality of life, and treatment compliance in those with a history of mild to moderate TBI and persistent cognitive complaints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART-CPT | Experimental | Behavioral: CPTCPT with additional elements of cognitive rehabilitation |
| CPT | Active comparator | Behavioral: CPTStandard Cognitive Processing Therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1) OEF/OIF veteran; 2) Current diagnosis of PTSD; 3) History of mild-to-moderate TBI; 4) Subjective cognitive complaints; 5) No anticipated/pending medication changes; 6) Written informed consent to participate in the study. -
- Exclusion Criteria:1) Active substance dependence, 2) Suicidal intent or attempt within the previous month; 3) Current psychotic disorder; 4) Dementia; 5) Non-English speaking; 6) Participation in other intervention studies.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CPT | Behavioural | CPT, SMART-CPT |
Primary outcome
PTSD Checklist
Time frame: change from baseline PTSD Checklist at 12 weeks (post-treatment)
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 9 May 2018.
- Derived from this study: PubMed 36204974Crocker LD, Sullan MJ, Jurick SM, Thomas KR, Davey DK, Hoffman SN, Twamley EW, Jak AJ. Baseline executive functioning moderates treatment-related changes in quality of life in veterans with posttraumatic stress disorder and comorbid traumatic brain injury. J Trauma Stress. 2023 Feb;36(1):94-105. doi: 10.1002/jts.22883. Epub 2022 Oct 6.
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.
Amy Jak, Ph.D. principal investigator
VA San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPT in people with PTSD With a History of Mild to Moderate TBI, run by San Diego Veterans Healthcare System 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 0 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 9 May 2018. 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?
PTSD Checklist (time frame: change from baseline PTSD Checklist at 12 weeks (post-treatment)). 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 NCT01943162, 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 9 May 2018.