Stress Disorders, Post-TraumaticCPT MOSTNCT05220137
Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy
A study testing Modified A-B-C: Working with Events, Thoughts, and Feelings, Challenging Questions and Patterns of Problematic Thinking in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
Cognitive Processing Therapy (CPT) consists of discrete therapeutic components that are delivered across 12 sessions, but most Veterans never reach session 12, and those who drop out receive only 4 sessions on average. Veterans drop out because of time constraints, logistics, and lack of perceived benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Modified A-B-C: Working with Events, Thoughts, and Feelings, Challenging Questions and Patterns of Problematic Thinking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2022to 15 May 2026
- 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
- The investigators designed the sample to be representative of Veterans with PTSD who are treated in PTSD Clinical Teams (PCTs), with minimal exclusion criteria. PCT clinicians will provide care for those with exclusionary comorbidities or preference for a medication-based approach, as per standard policies and procedures. Inclusion criteria are:
- score of 33 or above on the PCL-5
- at least 4 weeks on a stable dose for individuals who are taking psychotropic medication
- over the age of 18
Who cannot join
- active suicidality (assessed by the Columbia Suicide Severity Rating Scale with scores indicating elevated acute risk for suicide warranting hospitalization or intensive treatment)
- need for detoxification
- severe cognitive impairment that, in the judgment of the investigator, makes it unlikely that the patient can provide informed consent or adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
- psychosis or unmanaged bipolar disorder
- previous receipt of CPT in the past year
- current engagement in trauma-focused psychotherapy (Prolonged Exposure or Cognitive Processing Therapy)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220-2213
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
About this study
Cognitive Processing Therapy (CPT) consists of discrete therapeutic components that are delivered across 12 sessions, but most Veterans never reach session 12, and those who drop out receive only 4 sessions on average. Veterans drop out because of time constraints, logistics, and lack of perceived benefit. Unfortunately, Veterans who drop out prematurely may never receive the most effective components of CPT and continue to experience symptom-related distress and numerous other negative outcomes, including lost productivity, substance use, later-life physical disability, reduced quality of life, and increased risk of suicide.
The overall objective of this study is to adapt CPT into a brief, effective format. The rationale is that identifying the most effective intervention components and delivering only those components will make CPT deliverable in a shorter timeframe, thus improving efficiency, reducing drop-out related to poor treatment response, and ensuring that Veterans receive the most beneficial components of treatment, which will significantly improve their quality of life.
Read the detailed description
Background: One third of post-9/11 Veterans in VHA suffer from posttraumatic stress disorder (PTSD), and among those who initiate Cognitive Processing Therapy (CPT), up to 70% drop out before receiving an adequate dose of treatment. Unfortunately, Veterans who drop out prematurely may never receive the most effective components of CPT. Thus, there is an urgent need to use empirical approaches to identify the most effective components of CPT, so that CPT can be adapted into a briefer format. The long-term goal of this line of research is to adapt, test, and implement brief, evidence-based treatment for Veterans with PTSD. The overall objective of the current application is to adapt CPT into a brief, effective format. The rationale is that identifying the most effective intervention components and delivering only those components will make CPT deliverable in a shorter timeframe, thus improving efficiency, reducing drop-out related to poor treatment response, and ensuring that Veterans receive the most beneficial components of treatment, which will significantly improve their quality of life.
Significance/Impact: Upon completion of this project, the investigators expect to have produced an empirically-based, brief version of CPT. This contribution is likely to improve clinical practice for Veterans with PTSD by providing the most effective components at an earlier session, thus increasing the overall effectiveness of treatment and mitigating the negative consequences of untreated PTSD, such as lost productivity, substance use, later-life physical disability, reduced quality of life, and increased risk of suicide. Using a highly efficient experimental design, we will identify which of five CPT components contribute meaningfully to reduction in PTSD symptoms. The investigators will test the effectiveness of each component and each two-way interaction between components.
Methodology: The MOST is an innovative engineering-inspired framework that uses an optimization trial to assess the performance of individual intervention components within a multicomponent intervention such as CPT. Guided by the MOST framework, the goal of the proposed project is to empirically inform an abbreviated version of CPT via a highly efficient fractional factorial design. Veterans (N = 270) at three VAMCs with clinically significant PTSD symptoms who meet minimal inclusion/exclusion criteria will be randomized to receive two or more CPT components. This design will test the effectiveness of each component and each two-way interaction between components, as measured by PTSD symptom reduction on the Clinician-administered PTSD scale for DSM-5 (CAPS-5) across six months of follow-up.
Implementation/Next Steps: Upon completion of these aims, the expected outcome is an adapted, abbreviated version of CPT that consists of the most effective elements of the intervention. The adapted intervention will be primed for a future large scale, fully powered effectiveness trial. The adapted intervention can be easily disseminated through the VA CPT training program and will have a positive impact on the health and wellbeing of Veterans with PTSD.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Modified A-B-C: Working with Events, Thoughts, and Feelings, Challenging Questions, Patterns of Problematic Thinking, Challenging Beliefs, Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)
- Keywords
- Stress Disorders, Post-Traumatic, Veterans, Psychotherapy
- 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.
Modified A-B-C: Working with Events, Thoughts, and FeelingsBehavioural
The Modified A-B-C session teaches the Veteran how to draw connections between events, thoughts, and feelings and incorporates preliminary cognitive restructuring to help challenge stuck points. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.
Challenging QuestionsBehavioural
The Challenging Questions session teaches the Veteran to question and confront maladaptive self-statements and stuck points. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.
Patterns of Problematic ThinkingBehavioural
The Patterns of Problematic Thinking session teaches the Veteran to identify counterproductive thinking patterns. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.
Challenging BeliefsBehavioural
The Challenging Beliefs session teaches the Veteran to generate alternative thoughts based on the outcome of cognitive restructuring. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.
Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)Behavioural
The therapist will present the Module options to the Veteran and the Veteran will select one Module to work on. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Core Session 1, Core Session 2, Module Choice, Final Session Receives: Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy) |
| 2 | Active comparator | Core Session 1, Core Session 2, Modified A-B-C, Final Session Receives: Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings |
| 3 | Active comparator | Core Session 1, Core Session 2, Challenging Questions, Final Session Receives: Behavioral: Challenging Questions |
| 4 | Active comparator | Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Module Choice, Final Session Receives: Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings; Behavioral: Challenging Questions; Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy) |
| 5 | Active comparator | Core Session 1, Core Session 2, Problematic Patterns, Final Session Receives: Behavioral: Patterns of Problematic Thinking |
| 6 | Active comparator | Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Module Choice, Final Session Receives: Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings; Behavioral: Patterns of Problematic Thinking; Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy) |
| 7 | Active comparator | Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Module Choice, Final Session Receives: Behavioral: Challenging Questions; Behavioral: Patterns of Problematic Thinking; Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy) |
| 8 | Active comparator | Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Final Session Receives: Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings; Behavioral: Challenging Questions; Behavioral: Patterns of Problematic Thinking |
| 9 | Active comparator | Core Session 1, Core Session 2, Challenging Beliefs, Final Session Receives: Behavioral: Challenging Beliefs |
| 10 | Active comparator | Core Session 1, Core Session 2, Modified A-B-C , Challenging Beliefs, Module Choice, Final Session Receives: Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings; Behavioral: Challenging Beliefs; Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy) |
| 11 | Active comparator | Core Session 1, Core Session 2, Challenging Questions, Challenging Beliefs, Module Choice, Final Session Receives: Behavioral: Challenging Questions; Behavioral: Challenging Beliefs; Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy) |
| 12 | Active comparator | Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Challenging Beliefs, Final Session Receives: Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings; Behavioral: Challenging Questions; Behavioral: Challenging Beliefs |
| 13 | Active comparator | Core Session 1, Core Session 2, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session Receives: Behavioral: Patterns of Problematic Thinking; Behavioral: Challenging Beliefs; Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy) |
| 14 | Active comparator | Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Challenging Beliefs, Final Session Receives: Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings; Behavioral: Patterns of Problematic Thinking; Behavioral: Challenging Beliefs |
| 15 | Active comparator | Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Challenging Beliefs, Final Session Receives: Behavioral: Challenging Questions; Behavioral: Patterns of Problematic Thinking; Behavioral: Challenging Beliefs |
| 16 | Active comparator | Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session Receives: Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings; Behavioral: Challenging Questions; Behavioral: Patterns of Problematic Thinking; Behavioral: Challenging Beliefs; Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Change
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item structured interview used to measure of PTSD severity. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning and improvement in symptoms since a previous CAPS administration.
Scoring An index trauma/Criterion A event At least one Criterion B symptom (questions 1-5) At least one Criterion C symptom (questions 6-7) At least two Criterion D symptoms (questions 8-14) At least two Criterion E symptoms (questions 15-20) Both criterion F and G must be met as well for a PTSD diagnosis. To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity then combined to form a single severity score. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating.
Measured: Baseline, 6-week, 3-month, 6-month
Secondary outcomes (2)
PTSD Checklist for DSM-5 (PCL-5) Change
The PCL-5 is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80).The PCL-5 has strong internal consistency, test-retest reliability, and convergent and discriminant validity. Scores of 33 and above indicate a probable diagnosis of PTSD.
Measured: Baseline, 6-week, 3-month, 6-month
Patient Health Questionnaire (PHQ-9) Change
The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms. Patients are asked to rate the presence of symptoms over the past 2 weeks on a 4-point likert scale ranging from 0-3 (not at all, several days, more than half the days, nearly every day) with a range of scores between 0-27. Total scores ranging from 5-9 indicate mild depression, 10-14 indicate moderate depression, 15-19 indicate moderately severe depression, and 20-27 indicate severe depression.
Measured: Baseline, 6-week, 3-month, 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Aug 2022
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Factorial
- Model description
- Every condition in the experiment will begin with two initial core sessions (Rationale/Impact Statement and Working with Events, Thoughts, and Feelings) and end with a final core session. Each participant will then receive between one and five additional weekly sessions, as described below. The following CPT components will be empirically tested in the fractional factorial design: (1) Modified A-B-C, (2) Challenging Questions, (3) Patterns of Problematic Thinking, (4) Challenging Beliefs, and (5) Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy). Each component will be taught in a single session. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component. All treatment sequences will end with a final session that consists of final homework review, review of treatment progress, and relapse prevention techniques. In total, participants will receive between 4 and 8 sessions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Rebecca Kaufman Sripada, PhD MS, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220137
- Sponsor's protocol ID
- IIR 21-088
- Acronym
- CPT MOST
- Status last verified
- Jun 2026
- First submitted
- 21 Jan 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dodge J, Sullivan K, Grau PP, Chen C, Sripada R, Pfeiffer PN. Retention in Individual Trauma-Focused Treatment Following Family-Based Treatment Among US Veterans. JAMA Netw Open. 2023 Dec 1;6(12):e2349098. doi: 10.1001/jamanetworkopen.2023.49098.
PubMed 38127345Sripada RK, Peterson CL, Dziak JJ, Nahum-Shani I, Roberge EM, Martinson AA, Porter K, Grau P, Curtis D, McElroy S, Bryant S, Gracy I, Pryor C, Walters HM, Austin K, Ehlinger C, Sayer N, Wiltsey-Stirman S, Chard K. Using the multiphase optimization strategy to adapt cognitive processing therapy (CPT MOST): study protocol for a randomized controlled factorial experiment. Trials. 2023 Oct 19;24(1):676. doi: 10.1186/s13063-023-07669-3.
PubMed 37858262Saulnier KG, Brabbs S, Szymanski BR, Harpaz-Rotem I, McCarthy JF, Sripada RK. Suicide Risk Among Veterans Who Receive Evidence-Based Therapy for Posttraumatic Stress Disorder. JAMA Netw Open. 2024 Dec 2;7(12):e2452144. doi: 10.1001/jamanetworkopen.2024.52144.
PubMed 39724372Grau PP, Ganoczy D, Larsen SE, LoSavio ST, Sripada RK. Life After EBPs: Characterizing Subsequent Engagement in Evidence-Based Psychotherapy After Completion of an Initial Trauma-Focused EBP in a National Sample of VA Patients. Adm Policy Ment Health. 2025 Mar;52(2):441-453. doi: 10.1007/s10488-024-01422-x. Epub 2024 Nov 12.
PubMed 39532814
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy
- ClinicalTrials.gov ID
- NCT05220137
- Acronym / sponsor ID
- CPT MOST / IIR 21-088
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Stress Disorders, Post-Traumatic, Veterans, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 2 Feb 2022 (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.
Cognitive Processing Therapy (CPT) consists of discrete therapeutic components that are delivered across 12 sessions, but most Veterans never reach session 12, and those who drop out receive only 4 sessions on average. Veterans drop out because of time constraints, logistics, and lack of perceived benefit. Unfortunately, Veterans who drop out prematurely may never receive the most effective components of CPT and continue to experience symptom-related distress and numerous other negative outcomes, including lost productivity, substance use, later-life physical disability, reduced quality of life, and increased risk of suicide.
The overall objective of this study is to adapt CPT into a brief, effective format. The rationale is that identifying the most effective intervention components and delivering only those components will make CPT deliverable in a shorter timeframe, thus improving efficiency, reducing drop-out related to poor treatment response, and ensuring that Veterans receive the most beneficial components of treatment, which will significantly improve their quality of life.
Detailed description
Background: One third of post-9/11 Veterans in VHA suffer from posttraumatic stress disorder (PTSD), and among those who initiate Cognitive Processing Therapy (CPT), up to 70% drop out before receiving an adequate dose of treatment. Unfortunately, Veterans who drop out prematurely may never receive the most effective components of CPT. Thus, there is an urgent need to use empirical approaches to identify the most effective components of CPT, so that CPT can be adapted into a briefer format. The long-term goal of this line of research is to adapt, test, and implement brief, evidence-based treatment for Veterans with PTSD. The overall objective of the current application is to adapt CPT into a brief, effective format. The rationale is that identifying the most effective intervention components and delivering only those components will make CPT deliverable in a shorter timeframe, thus improving efficiency, reducing drop-out related to poor treatment response, and ensuring that Veterans receive the most beneficial components of treatment, which will significantly improve their quality of life.
Significance/Impact: Upon completion of this project, the investigators expect to have produced an empirically-based, brief version of CPT. This contribution is likely to improve clinical practice for Veterans with PTSD by providing the most effective components at an earlier session, thus increasing the overall effectiveness of treatment and mitigating the negative consequences of untreated PTSD, such as lost productivity, substance use, later-life physical disability, reduced quality of life, and increased risk of suicide. Using a highly efficient experimental design, we will identify which of five CPT components contribute meaningfully to reduction in PTSD symptoms. The investigators will test the effectiveness of each component and each two-way interaction between components.
Methodology: The MOST is an innovative engineering-inspired framework that uses an optimization trial to assess the performance of individual intervention components within a multicomponent intervention such as CPT. Guided by the MOST framework, the goal of the proposed project is to empirically inform an abbreviated version of CPT via a highly efficient fractional factorial design. Veterans (N = 270) at three VAMCs with clinically significant PTSD symptoms who meet minimal inclusion/exclusion criteria will be randomized to receive two or more CPT components. This design will test the effectiveness of each component and each two-way interaction between components, as measured by PTSD symptom reduction on the Clinician-administered PTSD scale for DSM-5 (CAPS-5) across six months of follow-up.
Implementation/Next Steps: Upon completion of these aims, the expected outcome is an adapted, abbreviated version of CPT that consists of the most effective elements of the intervention. The adapted intervention will be primed for a future large scale, fully powered effectiveness trial. The adapted intervention can be easily disseminated through the VA CPT training program and will have a positive impact on the health and wellbeing of Veterans with PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 16
- Model description
- Every condition in the experiment will begin with two initial core sessions (Rationale/Impact Statement and Working with Events, Thoughts, and Feelings) and end with a final core session. Each participant will then receive between one and five additional weekly sessions, as described below. The following CPT components will be empirically tested in the fractional factorial design: (1) Modified A-B-C, (2) Challenging Questions, (3) Patterns of Problematic Thinking, (4) Challenging Beliefs, and (5) Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy). Each component will be taught in a single session. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component. All treatment sequences will end with a final session that consists of final homework review, review of treatment progress, and relapse prevention techniques. In total, participants will receive between 4 and 8 sessions.
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)Core Session 1, Core Session 2, Module Choice, Final Session |
| 2 | Active comparator | Behavioral: Modified A-B-C: Working with Events, Thoughts, and FeelingsCore Session 1, Core Session 2, Modified A-B-C, Final Session |
| 3 | Active comparator | Behavioral: Challenging QuestionsCore Session 1, Core Session 2, Challenging Questions, Final Session |
| 4 | Active comparator | Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings, Behavioral: Challenging Questions, Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Module Choice, Final Session |
| 5 | Active comparator | Behavioral: Patterns of Problematic ThinkingCore Session 1, Core Session 2, Problematic Patterns, Final Session |
| 6 | Active comparator | Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings, Behavioral: Patterns of Problematic Thinking, Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Module Choice, Final Session |
| 7 | Active comparator | Behavioral: Challenging Questions, Behavioral: Patterns of Problematic Thinking, Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Module Choice, Final Session |
| 8 | Active comparator | Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings, Behavioral: Challenging Questions, Behavioral: Patterns of Problematic ThinkingCore Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Final Session |
| 9 | Active comparator | Behavioral: Challenging BeliefsCore Session 1, Core Session 2, Challenging Beliefs, Final Session |
| 10 | Active comparator | Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings, Behavioral: Challenging Beliefs, Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)Core Session 1, Core Session 2, Modified A-B-C , Challenging Beliefs, Module Choice, Final Session |
| 11 | Active comparator | Behavioral: Challenging Questions, Behavioral: Challenging Beliefs, Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)Core Session 1, Core Session 2, Challenging Questions, Challenging Beliefs, Module Choice, Final Session |
| 12 | Active comparator | Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings, Behavioral: Challenging Questions, Behavioral: Challenging BeliefsCore Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Challenging Beliefs, Final Session |
| 13 | Active comparator | Behavioral: Patterns of Problematic Thinking, Behavioral: Challenging Beliefs, Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)Core Session 1, Core Session 2, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session |
| 14 | Active comparator | Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings, Behavioral: Patterns of Problematic Thinking, Behavioral: Challenging BeliefsCore Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Challenging Beliefs, Final Session |
| 15 | Active comparator | Behavioral: Challenging Questions, Behavioral: Patterns of Problematic Thinking, Behavioral: Challenging BeliefsCore Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Challenging Beliefs, Final Session |
| 16 | Active comparator | Behavioral: Modified A-B-C: Working with Events, Thoughts, and Feelings, Behavioral: Challenging Questions, Behavioral: Patterns of Problematic Thinking, Behavioral: Challenging Beliefs, Behavioral: Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The investigators designed the sample to be representative of Veterans with PTSD who are treated in PTSD Clinical Teams (PCTs), with minimal exclusion criteria. PCT clinicians will provide care for those with exclusionary comorbidities or preference for a medication-based approach, as per standard policies and procedures. Inclusion criteria are:
- score of 33 or above on the PCL-5
- at least 4 weeks on a stable dose for individuals who are taking psychotropic medication
- over the age of 18
Key exclusion criteria (6 listed)
- active suicidality (assessed by the Columbia Suicide Severity Rating Scale with scores indicating elevated acute risk for suicide warranting hospitalization or intensive treatment)
- need for detoxification
- severe cognitive impairment that, in the judgment of the investigator, makes it unlikely that the patient can provide informed consent or adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
- psychosis or unmanaged bipolar disorder
- previous receipt of CPT in the past year
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 |
|---|---|---|
| Modified A-B-C: Working with Events, Thoughts, and FeelingsThe Modified A-B-C session teaches the Veteran how to draw connections between events, thoughts, and feelings and incorporates preliminary cognitive restructuring to help challenge stuck points. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component. | Behavioural | 10, 12, 14, 16, 2, 4, 6, 8 |
| Challenging QuestionsThe Challenging Questions session teaches the Veteran to question and confront maladaptive self-statements and stuck points. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component. | Behavioural | 11, 12, 15, 16, 3, 4, 7, 8 |
| Patterns of Problematic ThinkingThe Patterns of Problematic Thinking session teaches the Veteran to identify counterproductive thinking patterns. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component. | Behavioural | 13, 14, 15, 16, 5, 6, 7, 8 |
| Challenging BeliefsThe Challenging Beliefs session teaches the Veteran to generate alternative thoughts based on the outcome of cognitive restructuring. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component. | Behavioural | 10, 11, 12, 13, 14, 15, 16, 9 |
| Veteran's choice of Module (Safety/Trust/Power and Control/Esteem/Intimacy)The therapist will present the Module options to the Veteran and the Veteran will select one Module to work on. As in standard CPT, each session will begin with a review of homework from the previous session, and then provide the listed component. | Behavioural | 1, 10, 11, 13, 16, 4, 6, 7 |
Primary outcome
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Change
Time frame: Baseline, 6-week, 3-month, 6-month
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item structured interview used to measure of PTSD severity. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning and improvement in symptoms since a previous CAPS administration. Scoring An index trauma/Criterion A event At least one Criterion B symptom (questions 1-5) At least one Criterion C symptom (questions 6-7) At least two Criterion D symptoms (questions 8-14) At least two Criterion E symptoms (questions 15-20) Both criterion F and G must be met as well for a PTSD diagnosis. To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity then combined to form a single severity score. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating.
2 secondary outcomes
PTSD Checklist for DSM-5 (PCL-5) Change
Time frame: Baseline, 6-week, 3-month, 6-month
Patient Health Questionnaire (PHQ-9) Change
Time frame: Baseline, 6-week, 3-month, 6-month
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 10 Jun 2026.
- Background: PubMed 38127345Dodge J, Sullivan K, Grau PP, Chen C, Sripada R, Pfeiffer PN. Retention in Individual Trauma-Focused Treatment Following Family-Based Treatment Among US Veterans. JAMA Netw Open. 2023 Dec 1;6(12):e2349098. doi: 10.1001/jamanetworkopen.2023.49098.
- Results publication: PubMed 37858262Sripada RK, Peterson CL, Dziak JJ, Nahum-Shani I, Roberge EM, Martinson AA, Porter K, Grau P, Curtis D, McElroy S, Bryant S, Gracy I, Pryor C, Walters HM, Austin K, Ehlinger C, Sayer N, Wiltsey-Stirman S, Chard K. Using the multiphase optimization strategy to adapt cognitive processing therapy (CPT MOST): study protocol for a randomized controlled factorial experiment. Trials. 2023 Oct 19;24(1):676. doi: 10.1186/s13063-023-07669-3.
- Results publication: PubMed 39724372Saulnier KG, Brabbs S, Szymanski BR, Harpaz-Rotem I, McCarthy JF, Sripada RK. Suicide Risk Among Veterans Who Receive Evidence-Based Therapy for Posttraumatic Stress Disorder. JAMA Netw Open. 2024 Dec 2;7(12):e2452144. doi: 10.1001/jamanetworkopen.2024.52144.
- Results publication: PubMed 39532814Grau PP, Ganoczy D, Larsen SE, LoSavio ST, Sripada RK. Life After EBPs: Characterizing Subsequent Engagement in Evidence-Based Psychotherapy After Completion of an Initial Trauma-Focused EBP in a National Sample of VA Patients. Adm Policy Ment Health. 2025 Mar;52(2):441-453. doi: 10.1007/s10488-024-01422-x. Epub 2024 Nov 12.
- 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. This study is not recruiting at the moment.
Rebecca Kaufman Sripada, PhD MS principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified A-B-C: Working with Events, Thoughts, and Feelings, Challenging Questions and Patterns of Problematic Thinking in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 3 sites 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 4 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Change (time frame: Baseline, 6-week, 3-month, 6-month). 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 NCT05220137, which also lists 4 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 10 Jun 2026.