ACTIVE_NOT_RECRUITING

Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy

Quick Facts

Study Start:2022-08-01
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05220137

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * score of 33 or above on the PCL-5
  2. * at least 4 weeks on a stable dose for individuals who are taking psychotropic medication
  3. * over the age of 18
  1. * active suicidality (assessed by the Columbia Suicide Severity Rating Scale with scores indicating elevated acute risk for suicide warranting hospitalization or intensive treatment)
  2. * need for detoxification
  3. * 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)
  4. * psychosis or unmanaged bipolar disorder
  5. * previous receipt of CPT in the past year
  6. * current engagement in trauma-focused psychotherapy (Prolonged Exposure or Cognitive Processing Therapy)

Contacts and Locations

Principal Investigator

Rebecca Kaufman Sripada, PhD MS
PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Rebecca Kaufman Sripada, PhD MS, PRINCIPAL_INVESTIGATOR, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • Stress Disorders, Post-Traumatic
  • Veterans
  • Psychotherapy

Additional Relevant MeSH Terms

  • Stress Disorders, Post-Traumatic