Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy
NCT ID: NCT05220137
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
270 participants
INTERVENTIONAL
2022-08-01
2026-03-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
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.
TREATMENT
SINGLE
Study Groups
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1
Core Session 1, Core Session 2, Module Choice, Final Session
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.
2
Core Session 1, Core Session 2, Modified A-B-C, Final Session
Modified A-B-C: Working with Events, Thoughts, and Feelings
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.
3
Core Session 1, Core Session 2, Challenging Questions, Final Session
Challenging Questions
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.
4
Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Module Choice, Final Session
Modified A-B-C: Working with Events, Thoughts, and Feelings
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 Questions
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.
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.
5
Core Session 1, Core Session 2, Problematic Patterns, Final Session
Patterns of Problematic Thinking
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.
6
Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Module Choice, Final Session
Modified A-B-C: Working with Events, Thoughts, and Feelings
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.
Patterns of Problematic Thinking
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.
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.
7
Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Module Choice, Final Session
Challenging Questions
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 Thinking
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.
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.
8
Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Final Session
Modified A-B-C: Working with Events, Thoughts, and Feelings
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 Questions
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 Thinking
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.
9
Core Session 1, Core Session 2, Challenging Beliefs, Final Session
Challenging Beliefs
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.
10
Core Session 1, Core Session 2, Modified A-B-C , Challenging Beliefs, Module Choice, Final Session
Modified A-B-C: Working with Events, Thoughts, and Feelings
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 Beliefs
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)
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.
11
Core Session 1, Core Session 2, Challenging Questions, Challenging Beliefs, Module Choice, Final Session
Challenging Questions
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.
Challenging Beliefs
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)
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.
12
Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Challenging Beliefs, Final Session
Modified A-B-C: Working with Events, Thoughts, and Feelings
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 Questions
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.
Challenging Beliefs
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.
13
Core Session 1, Core Session 2, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session
Patterns of Problematic Thinking
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 Beliefs
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)
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.
14
Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Challenging Beliefs, Final Session
Modified A-B-C: Working with Events, Thoughts, and Feelings
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.
Patterns of Problematic Thinking
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 Beliefs
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.
15
Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Challenging Beliefs, Final Session
Challenging Questions
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 Thinking
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 Beliefs
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.
16
Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session
Modified A-B-C: Working with Events, Thoughts, and Feelings
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 Questions
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 Thinking
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 Beliefs
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)
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.
Interventions
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Modified A-B-C: Working with Events, Thoughts, and Feelings
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 Questions
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 Thinking
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 Beliefs
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)
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.
Eligibility Criteria
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Inclusion Criteria
* at least 4 weeks on a stable dose for individuals who are taking psychotropic medication
* over the age of 18
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Rebecca Kaufman Sripada, PhD MS
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Locations
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VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States
Countries
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References
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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.
Sripada 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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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IIR 21-088
Identifier Type: -
Identifier Source: org_study_id
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