Administrative information
Title {1} | Using the multiphase optimization strategy to adapt cognitive processing therapy (CPT MOST): study protocol for a randomized controlled factorial experiment |
Trial registration {2a and 2b}. | ClinicalTrials.gov Identifier: NCT05220137 |
Protocol version {3} | May 25, 2023; Version 1.0 |
Funding {4} | This research is funded by the VA Health Services Research and Development Service HSR&D I01 HX003487-01, IIR 21–088 (PI: Sripada). |
Author details {5a} | Rebecca K. Sripada: VA Center for Clinical Management Research, VA Ann Arbor Healthcare System; University of Michigan Department of Psychiatry Cassaundra L. Peterson: VA Center for Clinical Management Research, VA Ann Arbor Healthcare System John J. Dziak; Institute for Health Research and Policy, University of Illinois Chicago; Inbal Nahum-Shani; University of Michigan Institute for Social Research Erika M. Roberge; VA Salt Lake City Health Care System; University of Utah School of Medicine Amber A. Martinson; VA Salt Lake City Health Care System Katherine Porter; VA Ann Arbor Healthcare System Peter Grau; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System; University of Michigan Department of Psychiatry Diana Curtis; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System Sydney McElroy; Cincinnati VA Medical Center Sarah Bryant; VA Salt Lake City Health Care System Isabel Gracy; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System Cosette Pryor; VA Salt Lake City Health Care System Heather M. Walters: VA Center for Clinical Management Research, VA Ann Arbor Healthcare System; Karen Austin; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System Carolina Ehlinger; Cincinnati VA Medical Center; Nina Sayer; Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System Shannon Wiltsey-Stirman; VA National Center for PTSD; Stanford University Kathleen Chard; Cincinnati VA Medical Center; University of Cincinnati |
Name and contact information for the trial sponsor {5b} | Investigator initiated research; Rebecca Sripada (Principal Investigator); rebecca.sripada@va.gov. |
Role of sponsor {5c} | This is an investigator-initiated clinical trial. The funders played no role in the design of the study; the collection, analysis, and interpretation of data; or the writing of the manuscript. |
Introduction
Background and rationale {6a}
Importance of adapting CPT into a brief format
Theoretical framework
The multiphase optimization strategy (MOST) framework can be used to guide improvements to behavioral interventions through highly efficient experimentation
Objectives {7}
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Specific Aim 1: Using a highly efficient experimental design, identify which of five CPT components contribute meaningfully to reduction in PTSD symptoms. We 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 6 months of follow-up.
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Specific Aim 2: Identify mediators of component effectiveness. We hypothesize that effects will be mediated by engagement/adherence and change in posttraumatic cognitions.
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Exploratory Aim 1: Identify moderators of component effectiveness. We will test whether specific components and combinations of components are differentially effective by participant characteristics, including sex, age, and initial PTSD symptom severity.
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
CPT core components/functions
Tested components
Fractional factorial design
Condition | Core Session 1 (Brief Psychoeducation, Impact Statement) | Core Session 2 (A-B-C) | Modified A-B-C | Challenging Questions | Problematic Patterns | Challenging Beliefs | Module Choice | Final Session |
---|---|---|---|---|---|---|---|---|
1 | On | On | Off | Off | Off | Off | On | On |
2 | On | On | On | Off | Off | Off | Off | On |
3 | On | On | Off | On | Off | Off | Off | On |
4 | On | On | On | On | Off | Off | On | On |
5 | On | On | Off | Off | On | Off | Off | On |
6 | On | On | On | Off | On | Off | On | On |
7 | On | On | Off | On | On | Off | On | On |
8 | On | On | On | On | On | Off | Off | On |
9 | On | On | Off | Off | Off | On | Off | On |
10 | On | On | On | Off | Off | On | On | On |
11 | On | On | Off | On | Off | On | On | On |
12 | On | On | On | On | Off | On | Off | On |
13 | On | On | Off | Off | On | On | On | On |
14 | On | On | On | Off | On | On | Off | On |
15 | On | On | Off | On | On | On | Off | On |
16 | On | On | On | On | On | On | On | On |
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Therapist and evaluator training and consultation
Fidelity measures
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Measures | Time point |
---|---|
Screening | |
PTSD symptoms (PCL-5) | Screening |
Trauma history (THS) | Screening |
Psychiatric comorbidities (DIAMOND) | Screening |
PTSD symptoms (CAPS-5) | Screening |
Suicide risk (C-SSRS) | Screening |
Primary outcome | |
PTSD symptoms (CAPS-5) | Baseline, post-tx, 3-month, 6-month |
Secondary outcomes | |
PTSD symptoms (PCL-5) | Baseline, post-tx, 3-month, 6-month |
Functioning (B-IPF) | Baseline, post-tx, 3-month, 6-month |
Depression (PHQ-9) | Baseline, post-tx, 3-month, 6-month |
Suicide risk (C-SSRS) | Baseline, post-tx, 3-month, 6-month |
Pain Catastrophizing Scale | Baseline, post-tx, 3-month, 6-month |
WHO Disability Assessment Schedule (WHODAS 2.0) | Baseline, post-tx, 3-month, 6-month |
Patient satisfaction (CSQ-8) | Baseline, post-tx |
Service utilization | Baseline, post-tx, 3-month, 6-month |
Mechanisms and/or mediators | |
Posttraumatic cognitions (PTCI-9) | Baseline, post-tx, 3-month, 6-month |
Treatment engagement | Weekly during treatment |
Moderators | |
Demographics | Baseline |
Psychiatric comorbidities (DIAMOND) | Baseline |
Trauma type (THS) | Screening |
Fidelity measures | |
Content checklists | Weekly |
Review session audio | Weekly |
CPT fidelity measure | Weekly |