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PTSDNCT05310097

Cognitive Processing Therapy (CPT) Memory Support (MS) Study

A study testing CPT and MS in people with PTSD, run by Boston University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The efficacy of psychological interventions for posttraumatic stress disorder (PTSD) is likely limited by the difficulty participants have learning and remembering important therapy content. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PTSD
What is being tested?
CPT and MS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
4 Jan 2023to Apr 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Current diagnosis of PTSD as determined by the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
  • For potential participants on psychiatric medication, dose must be stable for the past four weeks.
  • Veteran status

Who cannot join

  • Current DSM-5 diagnoses of unstable bipolar disorder, past or present psychosis, or organic mental disorder
  • Active suicidal or homicidal ideation with plan or intent
  • Current moderate or severe substance use disorder, as defined by DSM-5 [i.e., at least 4 diagnostic symptoms of Substance use disorder (SUD) present]
  • Prior receipt of CPT or concurrent therapy for PTSD
  • Significant cognitive impairment as indicated by a score <10th percentile on the Montreal Cognitive Assessment
  • History of moderate or severe traumatic brain injury (TBI) based on the Ohio State University TBI Identification Method and Veterans Administration/ Department of Defense (VA/DOD) guidelines
  • High verbal memory ability, as indicated by a score >1 standard deviation (SD) above the population mean on the California Verbal Learning Test® Third Edition (CVLT-3) immediate recall task

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Joseph Carpenter, PhD MA contact

617-435-5319

jcarpen@bu.edu

United States1 site, 1 recruiting
  • VA Boston Healthcare System

    Jamaica Plain, Massachusetts, 02130

    Joseph Carpenter, PhD MA, 617-435-5319, jcarpen@bu.edu

    Recruiting

Other trials in United States

About this study

Official title: Enhancing Memory and Learning in Cognitive Processing Therapy for Post Traumatic Stress Disorder (PTSD)

The efficacy of psychological interventions for posttraumatic stress disorder (PTSD) is likely limited by the difficulty participants have learning and remembering important therapy content. Accordingly, the present study will examine the utility of integrating a Memory Support (MS) intervention into Cognitive Processing Therapy (CPT), an empirically supported and widely disseminated treatment for PTSD. MS was designed to integrate techniques aimed at facilitating encoding, consolidation, and retrieval of new learning into existing treatments, and has been shown to improve outcomes when integrated into cognitive therapy for depression. A pilot randomized controlled trial (n=52) comparing CPT with Memory Support (CPT+MS) to CPT-alone will be conducted. Study participants will be adults diagnosed with PTSD.

The primary aim of the trial will be to determine if CPT+MS will lead to greater memory and learning of therapy content relative to CPT-alone, and to establish the acceptability and feasibility of integrating MS into CPT. Secondary aims include a preliminary examination of treatment efficacy, as indicated by the magnitude of changes in PTSD symptoms between conditions, and target validation, as indicated by associations between memory and learning of therapy content and treatment response. Exploratory analyses will examine several indicators of baseline memory-related cognitive functioning as predictors of memory and learning of therapy content, providing preliminary data to inform future research on personalized application of MS. Results of the trial will advance scientific knowledge about methods for optimizing memory and learning as a mechanism for improving PTSD treatment outcomes.

Conditions
PTSD
Being tested
CPT, MS
Keywords
Cognitive Processing Therapy (CPT), Memory Support (MS), CPT + MS
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.

  • CPTBehavioural

    CPT will be delivered over the course of 12 one-hour weekly sessions (maximum of 18 weeks to complete treatment). Participants will have the option of receiving CPT in-person or via videoconferencing.

  • MSBehavioural

    The MS protocol consists of eight strategies: categorization, evaluation, application, cue-based reminders, practice remembering, attention recruitment, praising recall, and repetitions.

Study groups in NCT05310097
Study groupRoleWhat they receive
Cognitive Processing Therapy + Memory Support (CPT + MS)ExperimentalCPT + MS will involve the same treatment strategies as CPT while incorporating deliberate and frequent use of memory and learning support strategies. MS strategies are designed to enhance the memory of specific treatment points, defined as any insight, skill or strategy determined to be important for the patient to remember and/or implement. MS is not designed to enhance memory functioning generally, but rather improve the encoding, consolidation and retrieval of specific components of therapeutic learning.
Receives: Behavioral: CPT; Behavioral: MS
Cognitive Processing Therapy (CPT)Active comparatorCPT is a manualized, trauma-focused therapy for PTSD. Treatment consists of psychoeducation on the cognitive model of PTSD, identification of trauma-related stuck points (i.e. dysfunctional beliefs), and cognitive challenging techniques to help participants identify more realistic and adaptive ways of viewing their trauma, themselves, and the world.
Receives: Behavioral: CPT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mid-treatment Memory of therapy content assessed by the Therapy Recall Task

    The Therapy Recall Task involves participants writing down as many distinct "treatment points" as they can in a 10-minute period. Treatment points are defined as insights, skills, or strategies they think are important to remember or implement as part of their therapy. Responses are scored based on the number of distinct treatment points described.

    Measured: 6 weeks

  2. Post-treatment Memory of therapy content assessed by the Therapy Recall Task

    The Therapy Recall Task involves participants writing down as many distinct "treatment points" as they can in a 10-minute period. Treatment points are defined as insights, skills, or strategies they think are important to remember or implement as part of their therapy. Responses are scored based on the number of distinct treatment points described.

    Measured: 12 weeks

  3. Follow-up Memory of therapy content assessed by the Therapy Recall Task

    The Therapy Recall Task involves participants writing down as many distinct "treatment points" as they can in a 10-minute period. Treatment points are defined as insights, skills, or strategies they think are important to remember or implement as part of their therapy. Responses are scored based on the number of distinct treatment points described.

    Measured: 6 months

  4. Feasibility assessed by mean CPT Adherence

    CPT adherence is defined as the portion of CPT protocol elements completed across therapy sessions, rated from 0-100%. This will be assessed via observer ratings of a random selection of 25% of tapes/session recordings from each treatment condition using the CPT Therapist Adherence and Competence Protocol - Revised. Completion of ≥ 90% mean adherence to protocol elements indicates high CPT adherence, and would be an indicator of feasibility of CPT+MS.

    Measured: 12 weeks

  5. Feasibility assessed by mean CPT Competence

    CPT competence will be assessed via observer ratings of a random selection of 25% of tapes/session recordings from each treatment condition of the competence with which CPT protocol elements are delivered, rated from 1 (poor) to 7 (excellent). This will be assessed via observer ratings of a random selection of session recordings using the CPT Therapist Adherence and Competence Protocol - Revised. A mean skill rating of "good" or higher (≥5 on a 7-point Likert scale) on protocol elements indicates high CPT competence, and would be an indicator of feasibility of CPT+MS.

    Measured: 12 weeks

  6. Feasibility assessed by the Memory Support Rating Scale (MSRS)

    The Memory Support Rating Scale (MSRS) is an an observer-rated scale used to measure the type and frequency of Memory Support strategies used. A greater number of Memory Support strategies used in the CPT+MS condition compared to CPT will indicate feasibility of CPT+MS. A random selection of 25% of tapes from each treatment condition will be assessed to derive the mean Memory Support strategies used.

    Measured: 12 weeks

  7. Treatment acceptability after Session 1 assessed by the Credibility and Expectancy (CEQ) questionnaire

    The CEQ is a 6-item questionnaire that assesses how credible participants think the treatment they are receiving is and how much they expect to benefit, measured after the initial treatment session. The potential range of scores is 6 to 54 and higher scores indicating greater treatment credibility/acceptability.

    Measured: 1 week

  8. Mid-treatment acceptability assessed by the Working Alliance Inventory Short-Revised (WAI-R)

    The WAI-R is a 12-item self-report questionnaire that measures three aspects of the therapeutic alliance: agreement on tasks, agreement on goals, and affective bond with the therapist. The potential range of scores is 12 to 60 and higher scores indicate stronger therapeutic alliance/treatment acceptability.

    Measured: 6 weeks

  9. Post-treatment acceptability assessed by the Working Alliance Inventory Short-Revised (WAI-R)

    The WAI-R is a 12-item self-report questionnaire that measures three aspects of the therapeutic alliance: agreement on tasks, agreement on goals, and affective bond with the therapist. The potential range of scores is 12 to 60 and higher scores indicate stronger therapeutic alliance/treatment acceptability.

    Measured: 12 weeks

  10. Mid-treatment client satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)

    The CSQ is an 8-item self-report questionnaire that assesses client satisfaction with the treatment they received. The potential range of scores is 8 to 32 and higher scores suggest greater client satisfaction/treatment acceptability.

    Measured: 6 weeks

  11. Post-treatment client satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)

    The CSQ is an 8-item self-report questionnaire that assesses client satisfaction with the treatment they received. The potential range of scores is 8 to 32 and higher scores suggest greater client satisfaction/treatment acceptability.

    Measured: 12 weeks

Secondary outcomes (19)
  1. Mid-treatment Memory of Therapy Content assessed by the Treatment Thoughts and Application Task

    The Treatment Thoughts and Application Task assesses the number of treatment points participants thought about and applied in the previous 24 hours. Higher numbers of treatment points indicate greater memory and learning of therapy content.

    Measured: 6 weeks

  2. Post-treatment Memory of Therapy Content assessed by the Treatment Thoughts and Application Task

    The Treatment Thoughts and Application Task assesses the number of treatment points participants thought about and applied in the previous 24 hours. Higher numbers of treatment points indicate greater memory and learning of therapy content.

    Measured: 12 weeks

  3. Follow-up Memory of Therapy Content assessed by the Treatment Thoughts and Application Task

    The Treatment Thoughts and Application Task assesses the number of treatment points participants thought about and applied in the previous 24 hours. Higher numbers of treatment points indicate greater memory and learning of therapy content.

    Measured: 6 months

  4. Mid-treatment Change in Memory of Therapy Content assessed by the Generalization Task

    The Generalization Task asks participants to imagine two scenarios that commonly elicit symptom-related distress and asks how they would respond. Responses are coded based on the number of treatment points accurately described. Higher numbers of treatment points indicate greater ability to generalize/learn and remember therapy content.

    Measured: Baseline, 6 weeks

  5. Post-treatment Change in Memory of Therapy Content assessed by the Generalization Task

    The Generalization Task asks participants to imagine two scenarios that commonly elicit symptom-related distress and asks how they would respond. Responses are coded based on the number of treatment points accurately described. Higher numbers of treatment points indicate greater ability to generalize/learn and remember therapy content.

    Measured: Baseline, 12 weeks

  6. Follow-up Change in Memory of Therapy Content assessed by the Generalization Task

    The Generalization Task asks participants to imagine two scenarios that commonly elicit symptom-related distress and asks how they would respond. Responses are coded based on the number of treatment points accurately described. Higher numbers of treatment points indicate greater ability to generalize/learn and remember therapy content.

    Measured: Baseline, 6 months

  7. Mid-treatment Skills of Cognitive Therapy (SoCT) - Patient

    The SoCT - Patient is an 8-item self-report measure assessing comprehension and application of cognitive therapy skills. Scores range from 8 to 40, with higher scores indicating greater skill use and comprehension.

    Measured: 6 weeks

  8. Post-treatment Skills of Cognitive Therapy (SoCT) - Patient

    The SoCT - Patient is an 8-item self-report measure assessing comprehension and application of cognitive therapy skills. Scores range from 8 to 40, with higher scores indicating greater skill use and comprehension.

    Measured: 12 weeks

  9. Follow-up Skills of Cognitive Therapy (SoCT) - Patient

    The SoCT - Patient is an 8-item self-report measure assessing comprehension and application of cognitive therapy skills. Scores range from 8 to 40, with higher scores indicating greater skill use and comprehension.

    Measured: 6 months

  10. Mid-treatment Skills of Cognitive Therapy (SoCT) - Therapist

    The SoCT - Therapist is an 8-item measure assessing therapist's perception of their patient's comprehension and application of cognitive therapy skills. Scores range from 8 to 40, with higher scores indicating greater skill use and comprehension.

    Measured: 6 weeks

  11. Post-treatment Skills of Cognitive Therapy (SoCT) - Therapist

    The SoCT - Therapist is an 8-item measure assessing therapist's perception of their patient's comprehension and application of cognitive therapy skills. Scores range from 8 to 40, with higher scores indicating greater skill use and comprehension.

    Measured: 12 weeks

  12. Post-treatment Change in PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

    The CAPS-5 is a structured interview that will be used to assess PTSD severity based on the severity and frequency of the 20 DSM-5 symptom criteria of PTSD. Scores range from 0 to 80, with higher scores indicating more severe PTSD.

    Measured: Baseline, 12 weeks

  13. Follow-up Change in PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

    The CAPS-5 is a structured interview that will be used to assess PTSD severity based on the severity and frequency of the 20 DSM-5 symptom criteria of PTSD. Scores range from 0 to 80, with higher scores indicating more severe PTSD.

    Measured: Baseline, 6 months

  14. Post-treatment Change in PTSD symptoms assessed by the PTSD Checklist for DSM-5 (PCL-5)

    The PCL-5 is a 20-item self-report measure PTSD symptoms. Scores range from 0 to 80, with higher scores indicating more severe PTSD.

    Measured: Baseline, 12 weeks

  15. Follow-up Change in PTSD symptoms assessed by the PTSD Checklist for DSM-5 (PCL-5)

    The PCL-5 is a 20-item self-report measure PTSD symptoms. Scores range from 0 to 80, with higher scores indicating more severe PTSD.

    Measured: Baseline, 6 months

  16. Post-treatment Change in Depression symptoms assessed by the Patient Health Questionnaire 9-item (PHQ-9)

    The PHQ is a 9-item self-report measure of depression symptoms. Scores range from 0 to 27, with higher scores indicating more severe depression.

    Measured: Baseline, 12 weeks

  17. Follow-up Change in Depression symptoms assessed by the Patient Health Questionnaire 9-item (PHQ-9)

    The PHQ is a 9-item self-report measure of depression symptoms. Scores range from 0 to 27, with higher scores indicating more severe depression.

    Measured: Baseline, 6 months

  18. Post-treatment Change in general functioning assessed by the WHO Disability Assessment Scale-II (WHODAS-II)

    The WHODAS-II is a 36-item self-report questionnaire measuring disability and general functioning. Scores range from 0 to 144, with higher scores indicating greater disability/lower functioning

    Measured: Baseline, 12 weeks

  19. Follow-up Change in general functioning assessed by the WHO Disability Assessment Scale-II (WHODAS-II)

    The WHODAS-II is a 36-item self-report questionnaire measuring disability and general functioning. Scores range from 0 to 144, with higher scores indicating greater disability/lower functioning

    Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2022
  2. Study start4 Jan 2023
  3. Primary completionJan 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05310097
Sponsor's protocol ID
H-42343
Other IDs
1K23MH129878-01
Status last verified
Mar 2026
First submitted
25 Mar 2022
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CPT and MS in people with PTSD, run by Boston 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 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 1 Apr 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 Joseph Carpenter, PhD MA (617-435-5319, jcarpen@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mid-treatment Memory of therapy content assessed by the Therapy Recall Task (time frame: 6 weeks). The study lists 11 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 1 Apr 2026.

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