PTSDNCT06995612
SMART-CPT for PTSD/Concussion Implementation
A study testing SMART-CPT and CPT in people with PTSD and Concussion, Mild, run by San Diego Veterans Healthcare System at 1 site in United States.
Trial summary
The clinical implementation trial will evaluate effectiveness and feasibility, acceptability, appropriateness, barriers, and facilitators of implementing SMART-CPT, a treatment targeting the two primary factors leading to poor outcomes following concussion, in Veterans. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- PTSD, Concussion, Mild
- What is being tested?
- SMART-CPT and CPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- PTSD diagnosis;
- mild TBI sustained greater than three months prior to enrollment;
- cognitive complaints;
- not medicated or stable on prescribed psychiatric medication for at least 6 weeks prior to study enrollment with no anticipated/pending medication changes;
- English literacy.
Who cannot join
- mTBI sustained less than 3 months previously;
- history of moderate, severe, or penetrating TBI;
- history of other significant neurological condition unrelated to TBI;
- severe psychiatric disturbance expected to interfere with successful completion of the study;
- current severe alcohol or other substance use disorder;
- suicidal intent or attempt within the previous month;
Show all 12Show fewer
- current homicidal ideation;
- impaired decision making capacity;
- prior completion of five or more sessions of CPT or cognitive rehabilitation; -concurrent participation in other intervention studies for PTSD or TBI;
- life threatening or unstable medical illness;
- inability to read;
- dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SMART-CPT for PTSD and History of Concussion: A Pragmatic Implementation Trial
The clinical implementation trial will evaluate effectiveness and feasibility, acceptability, appropriateness, barriers, and facilitators of implementing SMART-CPT, a treatment targeting the two primary factors leading to poor outcomes following concussion, in Veterans. It will test effectiveness and broad implementation feasibility of SMART-CPT compared to standard Cognitive Processing Therapy (CPT).
- Conditions
- PTSD, Concussion, Mild
- Being tested
- SMART-CPT, CPT
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART-CPTBehavioural
SMART-CPT T is a psychotherapy that combines Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) and Cognitive Symptom Management and Rehabilitation Training (CogSMART) for neurobehavioral and neurocognitive symptoms to simultaneously target persistent postconcussive symptoms and PTSD
CPTBehavioural
CPT is a cognitive behavioral treatment specifically targeting PTSD and other corollary symptoms following traumatic events (Resick \& Schnicke, 1992). Based on a social cognitive theory of PTSD and trauma, CPT focuses on identifying the content of trauma-related thoughts, examining whether these thoughts are consistent or inconsistent with a patient's prior beliefs about the world, and addressing the impact these thoughts have on emotions and behaviors. Patients are taught to recognize and challenge thought patterns such as, assimilation (distorting the memory of the traumatic event to fit prior world beliefs), over-accommodation (excessively altering world beliefs to be consistent with the trauma), or the reinforcement of previously held distorted world beliefs.
| Study group | Role | What they receive |
|---|---|---|
| SMART-CPT | Experimental | Not described Receives: Behavioral: SMART-CPT |
| CPT | Active comparator | Not described Receives: Behavioral: CPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist (PCL5)
A brief self-report instrument to measure PTSD symptom severity. It consists of 20 items, scored on a 5-point scale (0 = not at all to 5 = extremely), that correspond to the DSM-5 symptoms of PTSD. It will be used to track PTSD symptom reporting weekly as well as at comprehensive assessments
Measured: weekly through treatment completion, an average of 3 months
Neurobehavioral Symptom Inventory (NSI)
A 22 item self-report measure of neurobehavioral symptoms commonly experienced following a mTBI that will be utilized to assess inclusionary cognitive complaints as well as monitor overall neurobehavioral symptoms weekly and at comprehensive assessments.
Measured: weekly through treatment completion, an average of 3 months
The Patient Global Impression of Change (PGIC)
A single-item measure of activity limitations, symptoms, and overall quality of life
Measured: at treatment completion, an average of three months
Brief Inventory of Psychosocial Functioning (B-IPF)
7-item measure of PTSD psychosocial functional impairment
Measured: at 3 primary assessment timepoints, week 0, week 12, week 24
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
will measure function in the following areas: life activities (work, school, domestic responsibilities), cognition, mobility, self-care, social, and community participation
Measured: at 3 primary assessment timepoints; week 0, week 12, week 24
Traumatic Brain Injury Quality of Life Scale (TBI-QOL)
provides comprehensive patient-reported outcomes specific to TBI.
Measured: at 3 primary assessment timepoints; week 0, week 12, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Dec 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Amy Jak, San Diego Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995612
- Sponsor's protocol ID
- TP220123
- Status last verified
- Mar 2025
- First submitted
- 5 Jan 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data will be uploaded to FITBIR for aggregation and secondary analyses by other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART-CPT for PTSD and History of Concussion: A Pragmatic Implementation Trial
- ClinicalTrials.gov ID
- NCT06995612
- Acronym / sponsor ID
- TP220123
- Conditions
- PTSD, Concussion, Mild
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- San Diego Veterans Healthcare SystemUS federal agency
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 May 2025 (actual)
- 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 clinical implementation trial will evaluate effectiveness and feasibility, acceptability, appropriateness, barriers, and facilitators of implementing SMART-CPT, a treatment targeting the two primary factors leading to poor outcomes following concussion, in Veterans. It will test effectiveness and broad implementation feasibility of SMART-CPT compared to standard Cognitive Processing Therapy (CPT).
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: SMART-CPT |
| CPT | Active comparator | Behavioral: CPT |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- PTSD diagnosis;
- mild TBI sustained greater than three months prior to enrollment;
- cognitive complaints;
- not medicated or stable on prescribed psychiatric medication for at least 6 weeks prior to study enrollment with no anticipated/pending medication changes;
- English literacy.
Key exclusion criteria (12 listed)
- mTBI sustained less than 3 months previously;
- history of moderate, severe, or penetrating TBI;
- history of other significant neurological condition unrelated to TBI;
- severe psychiatric disturbance expected to interfere with successful completion of the study;
- current severe alcohol or other substance use disorder;
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 |
|---|---|---|
| SMART-CPTSMART-CPT T is a psychotherapy that combines Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) and Cognitive Symptom Management and Rehabilitation Training (CogSMART) for neurobehavioral and neurocognitive symptoms to simultaneously target persistent postconcussive symptoms and PTSD | Behavioural | SMART-CPT |
| CPTCPT is a cognitive behavioral treatment specifically targeting PTSD and other corollary symptoms following traumatic events (Resick \& Schnicke, 1992). Based on a social cognitive theory of PTSD and trauma, CPT focuses on identifying the content of trauma-related thoughts, examining whether these thoughts are consistent or inconsistent with a patient's prior beliefs about the world, and addressing the impact these thoughts have on emotions and behaviors. Patients are taught to recognize and challenge thought patterns such as, assimilation (distorting the memory of the traumatic event to fit prior world beliefs), over-accommodation (excessively altering world beliefs to be consistent with the trauma), or the reinforcement of previously held distorted world beliefs. | Behavioural | CPT |
Primary outcome
PTSD Checklist (PCL5)
Time frame: weekly through treatment completion, an average of 3 months
A brief self-report instrument to measure PTSD symptom severity. It consists of 20 items, scored on a 5-point scale (0 = not at all to 5 = extremely), that correspond to the DSM-5 symptoms of PTSD. It will be used to track PTSD symptom reporting weekly as well as at comprehensive assessments
Neurobehavioral Symptom Inventory (NSI)
Time frame: weekly through treatment completion, an average of 3 months
A 22 item self-report measure of neurobehavioral symptoms commonly experienced following a mTBI that will be utilized to assess inclusionary cognitive complaints as well as monitor overall neurobehavioral symptoms weekly and at comprehensive assessments.
The Patient Global Impression of Change (PGIC)
Time frame: at treatment completion, an average of three months
A single-item measure of activity limitations, symptoms, and overall quality of life
Brief Inventory of Psychosocial Functioning (B-IPF)
Time frame: at 3 primary assessment timepoints, week 0, week 12, week 24
7-item measure of PTSD psychosocial functional impairment
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: at 3 primary assessment timepoints; week 0, week 12, week 24
will measure function in the following areas: life activities (work, school, domestic responsibilities), cognition, mobility, self-care, social, and community participation
Traumatic Brain Injury Quality of Life Scale (TBI-QOL)
Time frame: at 3 primary assessment timepoints; week 0, week 12, week 24
provides comprehensive patient-reported outcomes specific to TBI.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Yes. All de-identified data will be uploaded to FITBIR for aggregation and secondary analyses by other investigators.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART-CPT and CPT in people with PTSD and Concussion, Mild, 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 5 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 4 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 (PCL5) (time frame: weekly through treatment completion, an average of 3 months). The study lists 6 primary outcomes in all. 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 4 Jun 2025.