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

NCT06671158 | Recruiting

• 1 other identifier: IRB-23-1992
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressive Disorder; Anxiety Disorders

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Brief Adjustment Scale-6 (BASE-6)

  Self-report questionnaire designed to measure general psychological adjustment and functioning of adult-aged individuals Minimum score: 6 Maximum score: 42 A higher score indicates severe difficulty in psychological adaptation and functioning/worse outcome

  Completed weekly through study completion, an average of 3 to 4 months

• Patient Health Questionnaire-9 (PHQ-9)

  Evaluate depression symptoms Minimum score: 0 Maximum score: 27 A higher score indicates more severe depression/worse outcome

  Completed weekly through study completion, an average of 3 to 4 months

• Generalized Anxiety Disorder-7 (GAD-7)

  evaluate anxiety symptoms Minimum score: 0 Maximum score: 21 A higher score indicates more severe anxiety/worse outcome

  Completed weekly through study completion, an average of 3 to 4 months

Secondary Outcomes (3)

• World Health Organization Quality of Life-Brief (WHOQOL-BREF)

  Pre-post, through study completion, an average of 3 to 4 months

• Working Alliance Inventory-Short Form Revised (WAI-SR)

  Completed monthly, through study completion, an average of 3 to 4 months

• Vanderbilt Psychotherapy Process Scale - Patient version (VPPS)

  Completed every 6 weeks; through study completion, an average of 3 to 4 months

Other Outcomes (5)

• Clinical Global Impressions - Severity of Illness (CGI-S)

  Pre-post, through study completion, an average of 3 to 4 months

• Patient's Global Impressions of Severity (PGI-S)

  Pre-post, through study completion, an average of 3 to 4 months

• Clinical Global Impressions - Improvement (CGI-I)

  Through study completion, an average of 3 to 4 months

Study Arms (3)

Measurement-based care group

EXPERIMENTAL

Measurement-based care group

Behavioral: Psychotherapy

Treatment-as-Usual group

ACTIVE COMPARATOR

Treatment-as-Usual group

Behavioral: Psychotherapy

Waitlist control group

NO INTERVENTION

Waitlist control group

Interventions

Psychotherapy BEHAVIORAL

Individual psychotherapy for weekly 12-sessions

Measurement-based care group; Treatment-as-Usual group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• being 18 years old or older.

You may not qualify if:

• 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);
• currently receiving psychotherapy through another source;
• significant suicidal/homicidal risk that would need immediate intervention;
• do not have ability complete Patient-Rated Outcome Measures (PROMs) either in person or remotely

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Mental Health

Roanoke, Virginia, 24018, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Virginia O'Brien, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita Kablinger, MD

CONTACT

540-527-4875; askablinger@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: November 4, 2024
• Study Start: October 10, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-10

Locations

US (1)