RECRUITING

Measurement-Based Care (MBC) Implementation, Effectiveness, and Mechanisms of Change

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

Although measurement-based care (MBC) is an evidence-based practice with known benefits, it is not always systematically implemented with fidelity. Questions remain regarding MBC's unique added value compared to usual care. Thus, the goal of this clinical trial is to investigate the implementation outcome, effectiveness, and mechanisms of change of measurement-based care in adult behavioral health. This study implemented MBC in adult ambulatory behavioral health and will test outcomes using a pragmatic randomized control trial within the RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) framework. Researchers will compare three groups: 1) the Measurement-based care group, 2) the treatment-as-usual group, and 3) the waitlist control group. Participants will participate in weekly individual psychotherapy sessions for 12 sessions in total.

Official Title

An Evaluation of the Effectiveness and Mechanisms of Change of Measurement Based Care for Depressive and Anxiety Disorders

Quick Facts

Study Start:2023-10-10
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06671158

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. 1. Primary concern and referral reason for seeking psychotherapy are either depressive- or anxiety-related symptoms and/or psychological distress, using minimum scores as follows: PHQ-9 (score \> 4), GAD-7 (score \> 4), and BASE-6 (score \> 18), and
  2. 2. being 18 years old or older.
  1. 1. Severe physical or psychiatric conditions that would hinder the treatment (e.g., clients with acute psychosis, intellectual disability, or neurocognitive disorders who do not have the capacity to undergo informed consent and participate in the study);
  2. 2. currently receiving psychotherapy through another source;
  3. 3. significant suicidal/homicidal risk that would need immediate intervention;
  4. 4. do not have ability complete Patient-Rated Outcome Measures (PROMs) either in person or remotely

Contacts and Locations

Study Contact

Anita Kablinger, MD
CONTACT
540-527-4875
askablinger@carilionclinic.org

Principal Investigator

Virginia O'Brien, MD
PRINCIPAL_INVESTIGATOR
Carilion Clinic

Study Locations (Sites)

Carilion Mental Health
Roanoke, Virginia, 24018
United States

Collaborators and Investigators

Sponsor: Carilion Clinic

  • Virginia O'Brien, MD, PRINCIPAL_INVESTIGATOR, Carilion Clinic

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 Date2023-10-10
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-10-10
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • measurement-based care
  • effectiveness
  • RCT
  • implementation
  • psychotherapy
  • mechanisms of change

Additional Relevant MeSH Terms

  • Depressive Disorder
  • Anxiety Disorders