Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy
CPT MOST
1 other identifier
interventional
270
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2022
CompletedFirst Posted
Study publicly available on registry
February 2, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedSeptember 24, 2025
September 1, 2025
3.7 years
January 21, 2022
September 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 6-week, 3-month, 6-month
Secondary Outcomes (2)
PTSD Checklist for DSM-5 (PCL-5) Change
Baseline, 6-week, 3-month, 6-month
Patient Health Questionnaire (PHQ-9) Change
Baseline, 6-week, 3-month, 6-month
Study Arms (16)
1
ACTIVE COMPARATORCore Session 1, Core Session 2, Module Choice, Final Session
2
ACTIVE COMPARATORCore Session 1, Core Session 2, Modified A-B-C, Final Session
3
ACTIVE COMPARATORCore Session 1, Core Session 2, Challenging Questions, Final Session
4
ACTIVE COMPARATORCore Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Module Choice, Final Session
5
ACTIVE COMPARATORCore Session 1, Core Session 2, Problematic Patterns, Final Session
6
ACTIVE COMPARATORCore Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Module Choice, Final Session
7
ACTIVE COMPARATORCore Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Module Choice, Final Session
8
ACTIVE COMPARATORCore Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Final Session
9
ACTIVE COMPARATORCore Session 1, Core Session 2, Challenging Beliefs, Final Session
10
ACTIVE COMPARATORCore Session 1, Core Session 2, Modified A-B-C , Challenging Beliefs, Module Choice, Final Session
11
ACTIVE COMPARATORCore Session 1, Core Session 2, Challenging Questions, Challenging Beliefs, Module Choice, Final Session
12
ACTIVE COMPARATORCore Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Challenging Beliefs, Final Session
13
ACTIVE COMPARATORCore Session 1, Core Session 2, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session
14
ACTIVE COMPARATORCore Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Challenging Beliefs, Final Session
15
ACTIVE COMPARATORCore Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Challenging Beliefs, Final Session
16
ACTIVE COMPARATORCore Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session
Interventions
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.
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.
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.
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.
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
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303, United States
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220-2213, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001, United States
Related Publications (2)
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.
PMID: 38127345BACKGROUNDSripada 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.
PMID: 37858262RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Kaufman Sripada, PhD MS
VA Ann Arbor Healthcare System, Ann Arbor, MI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2022
First Posted
February 2, 2022
Study Start
August 1, 2022
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
September 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share