Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy

Completed · Not applicable

Conditions studied: Stress Disorders, Post-Traumatic

In brief

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.

Key facts

Study ID

NCT05220137

Run by

VA Office of Research and Development

People needed

271

Starts

2022-08-01

Expected to finish

2026-05-15

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.