Stress Disorders, Post-TraumaticMSCPTPTSDNCT06000475
Enhancing Memory in Cognitive Processing Therapy for PTSD
A study testing Cognitive Processing Therapy and Cognitive Processing Therapy (CPT) + Memory Support in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Several psychotherapies for posttraumatic stress disorder (PTSD) have a strong evidence base for their efficacy, but nonresponse rates are high, particularly among older Veterans. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Cognitive Processing Therapy and Cognitive Processing Therapy (CPT) + Memory Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 31 Dec 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans with DSM-5 diagnoses of PTSD via the Clinician Administered PTSD Scale (CAPS-5)
Who cannot join
- daily benzodiazepine use (due to memory impairing effects)
- bipolar or psychotic disorders
- current suicidal ideation with plan or intent
- current moderate or severe substance use disorder not in remission for >1 month
- severe traumatic brain injury
- a Montreal Cognitive Assessment (MoCA) indicative of dementia
- or other disorders that would severely limit study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
Kyong-Mi Chang, MD, (215) 823-5893, Kyong-Mi.Chang@va.gov
Richard A Moore, (215) 823-5800 ext. 7916, richard.moore7@va.gov
About this study
Official title: Enhancing Memory in Cognitive Processing Therapy for Older Adults With PTSD
Several psychotherapies for posttraumatic stress disorder (PTSD) have a strong evidence base for their efficacy, but nonresponse rates are high, particularly among older Veterans. Accumulating evidence indicates that memory deficits and poor learning of therapy contents adversely affect psychotherapy treatment response in PTSD. However, limited research has examined methods for increasing learning of therapy contents in psychotherapy for PTSD. The proposed study aims to examine the feasibility of integrating an intervention to increase learning and memory of psychotherapy content into the provision of a widely used psychotherapy, cognitive processing therapy (CPT), for older adults with PTSD. The ultimate goal of this line of research is to develop novel rehabilitation interventions to increase functioning for individuals with PTSD.
Read the detailed description
Posttraumatic stress disorder (PTSD) is prevalent among Veterans and is a substantial public health burden. Several psychotherapies, including cognitive processing therapy (CPT), have a strong evidence base for their efficacy in PTSD. However, many individuals show limited benefit from such treatments, particularly older Veterans. One factor likely affecting treatment response is poor encoding, storage, and retrieval of the skills and treatment points that are learned in psychotherapy. Individuals with PTSD display deficits in learning and memory, and aging is independently associated with declines in memory and executive functioning. Thus, older adults with PTSD may be at heightened risk of cognitive dysfunction that could impact their ability to benefit from frontline PTSD treatments. To this end, pre-treatment memory functioning has been shown to consistently predict treatment response in psychotherapy for PTSD. Inefficient learning and memory for psychotherapy content may be one mechanism explaining this relationship, as poor learning of therapy content is linked with worse treatment adherence and outcomes. The primary aim of this proposal is to examine the feasibility and acceptability of integrating a novel Memory Support intervention into the provision of CPT for older adults with PTSD. The Memory Support intervention was developed such that specific strategies to enhance encoding and retrieval of therapy content and skills can be integrated into manualized psychotherapy. However, no prior studies have integrated this intervention into treatments for PTSD. The proposed project will be guided by a user-centered design framework for treatment development and be conducted in three phases. In the first phase, the investigators will develop a modified CPT treatment manual that systematically integrates Memory Support, with clinician (n=3) and Veteran (n=3) feedback to provide guidance on process and techniques. In the next phase, the investigators will conduct iterative refinement of the modified treatment through a case series in older Veterans (n=3) with an experienced CPT therapist. Finally, the investigators will conduct a small feasibility randomized controlled trial (n=20) in which the investigators will examine accrual, retention, completion, acceptability, and variability in symptom and functional outcomes, as well as all procedures for a larger trial. The proposed project offers substantial conceptual innovations by bridging foundational work from rehabilitation neuropsychology and psychotherapy mechanisms research and will provide valuable pilot data to inform a novel intervention for older Veterans with PTSD that can be tested in future large-scale studies. Such approaches may be especially relevant for Veterans with neurocognitive deficits (e.g., memory), potentially suggesting a target for a personalized approach to mental health care.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Cognitive Processing Therapy, Cognitive Processing Therapy (CPT) + Memory Support
- Keywords
- Stress Disorders, Post-Traumatic, Psychotherapy, Memory
- 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 TherapyBehavioural
Also called CPT
CPT as described in the treatment manual
Cognitive Processing Therapy (CPT) + Memory SupportBehavioural
CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy (CPT) | Active comparator | Standard CPT as described in the treatment manual Receives: Behavioral: Cognitive Processing Therapy |
| Cognitive Processing Therapy (CPT) + Memory Support | Experimental | CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content. Receives: Behavioral: Cognitive Processing Therapy; Behavioral: Cognitive Processing Therapy (CPT) + Memory Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist-5 (PCL-5)
Questionnaire for symptoms of PTSD; the range of the scale is from 0 (no symptoms) to 80 (maximal symptoms)
Measured: Through study completion, weeks 12-16 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start15 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James C. Scott, PhD, Principal investigator, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000475
- Sponsor's protocol ID
- D4627-P
- Other IDs
- 1I21RX004627
- Acronym
- MSCPTPTSD
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Memory in Cognitive Processing Therapy for Older Adults With PTSD
- ClinicalTrials.gov ID
- NCT06000475
- Acronym / sponsor ID
- MSCPTPTSD / D4627-P
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Stress Disorders, Post-Traumatic, Psychotherapy, Memory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Aug 2023 (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.
Several psychotherapies for posttraumatic stress disorder (PTSD) have a strong evidence base for their efficacy, but nonresponse rates are high, particularly among older Veterans. Accumulating evidence indicates that memory deficits and poor learning of therapy contents adversely affect psychotherapy treatment response in PTSD. However, limited research has examined methods for increasing learning of therapy contents in psychotherapy for PTSD. The proposed study aims to examine the feasibility of integrating an intervention to increase learning and memory of psychotherapy content into the provision of a widely used psychotherapy, cognitive processing therapy (CPT), for older adults with PTSD. The ultimate goal of this line of research is to develop novel rehabilitation interventions to increase functioning for individuals with PTSD.
Detailed description
Posttraumatic stress disorder (PTSD) is prevalent among Veterans and is a substantial public health burden. Several psychotherapies, including cognitive processing therapy (CPT), have a strong evidence base for their efficacy in PTSD. However, many individuals show limited benefit from such treatments, particularly older Veterans. One factor likely affecting treatment response is poor encoding, storage, and retrieval of the skills and treatment points that are learned in psychotherapy. Individuals with PTSD display deficits in learning and memory, and aging is independently associated with declines in memory and executive functioning. Thus, older adults with PTSD may be at heightened risk of cognitive dysfunction that could impact their ability to benefit from frontline PTSD treatments. To this end, pre-treatment memory functioning has been shown to consistently predict treatment response in psychotherapy for PTSD. Inefficient learning and memory for psychotherapy content may be one mechanism explaining this relationship, as poor learning of therapy content is linked with worse treatment adherence and outcomes. The primary aim of this proposal is to examine the feasibility and acceptability of integrating a novel Memory Support intervention into the provision of CPT for older adults with PTSD. The Memory Support intervention was developed such that specific strategies to enhance encoding and retrieval of therapy content and skills can be integrated into manualized psychotherapy. However, no prior studies have integrated this intervention into treatments for PTSD. The proposed project will be guided by a user-centered design framework for treatment development and be conducted in three phases. In the first phase, the investigators will develop a modified CPT treatment manual that systematically integrates Memory Support, with clinician (n=3) and Veteran (n=3) feedback to provide guidance on process and techniques. In the next phase, the investigators will conduct iterative refinement of the modified treatment through a case series in older Veterans (n=3) with an experienced CPT therapist. Finally, the investigators will conduct a small feasibility randomized controlled trial (n=20) in which the investigators will examine accrual, retention, completion, acceptability, and variability in symptom and functional outcomes, as well as all procedures for a larger trial. The proposed project offers substantial conceptual innovations by bridging foundational work from rehabilitation neuropsychology and psychotherapy mechanisms research and will provide valuable pilot data to inform a novel intervention for older Veterans with PTSD that can be tested in future large-scale studies. Such approaches may be especially relevant for Veterans with neurocognitive deficits (e.g., memory), potentially suggesting a target for a personalized approach to mental health care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy (CPT) | Active comparator | Behavioral: Cognitive Processing TherapyStandard CPT as described in the treatment manual |
| Cognitive Processing Therapy (CPT) + Memory Support | Experimental | Behavioral: Cognitive Processing Therapy, Behavioral: Cognitive Processing Therapy (CPT) + Memory SupportCPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans with DSM-5 diagnoses of PTSD via the Clinician Administered PTSD Scale (CAPS-5)
Key exclusion criteria (7 listed)
- daily benzodiazepine use (due to memory impairing effects)
- bipolar or psychotic disorders
- current suicidal ideation with plan or intent
- current moderate or severe substance use disorder not in remission for >1 month
- severe traumatic 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 Processing TherapyAlso: CPTCPT as described in the treatment manual | Behavioural | Cognitive Processing Therapy (CPT), Cognitive Processing Therapy (CPT) + Memory Support |
| Cognitive Processing Therapy (CPT) + Memory SupportCPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content. | Behavioural | Cognitive Processing Therapy (CPT) + Memory Support |
Primary outcome
PTSD Checklist-5 (PCL-5)
Time frame: Through study completion, weeks 12-16 of treatment
Questionnaire for symptoms of PTSD; the range of the scale is from 0 (no symptoms) to 80 (maximal symptoms)
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 30 Jul 2026.
- Individual participant dataSharing planned: No
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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.
James C. Scott, PhD principal investigator
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
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 and Cognitive Processing Therapy (CPT) + Memory Support in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development 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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. 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?
Contact James C Scott, PhD ((215) 823-5800 ext. 7138, James.Scott2de50a@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist-5 (PCL-5) (time frame: Through study completion, weeks 12-16 of treatment). 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 30 Jul 2026.