Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy

Stress Disorders, Post-Traumatic Clinical Trial

— CPT MOST  

Official title:

Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220137
• Other study ID #: IIR 21-088
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: Rebecca K Sripada, PhD MS
• Phone: (734) 222-7432
• Email: rebecca.sripada[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: March 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, 6-week, 3-month, 6-month
Secondary	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.	Baseline, 6-week, 3-month, 6-month