Clinical trial NCT05220137: Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy
Official title: Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Stress Disorders, Post-Traumatic
Veterans
Psychotherapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-02-02
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Change
timeFrame: Baseline, 6-week, 3-month, 6-month
Secondary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5) Change
timeFrame: Baseline, 6-week, 3-month, 6-month
measure: Patient Health Questionnaire (PHQ-9) Change
timeFrame: Baseline, 6-week, 3-month, 6-month
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center, Cincinnati, OH
state: Ohio
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Rebecca Kaufman Sripada, PhD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.