Anxiety Disorders, Depressive Disorder
Conditions
Keywords
measurement-based care, effectiveness, RCT, implementation, psychotherapy, mechanisms of change
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.
Detailed description
Measurement-based care (MBC) is an evidenced-based practice, involving routine completion of patient-reported outcome measures and collaborative discussions between clinician and client to inform clinical decision-making and facilitate improvement. Despite its known benefits, such as reduced dropout rates and improved treatment outcomes, questions remain regarding MBC's unique effectiveness compared to standard care. Furthermore, mechanisms of change on how MBC actually works in treatment have yet to be fully investigated. Thus, the current study aims to conduct a randomized control trial to evaluate the added value of MBC, by comparing an MBC+psychotherapy group, a psychotherapy-only group, and a waitlist group with no interventions.
Interventions
BEHAVIORALPsychotherapy
Individual psychotherapy for weekly 12-sessions
Sponsors
Carilion Clinic
Virginia Polytechnic Institute and State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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. being 18 years old or older.
Exclusion criteria
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. currently receiving psychotherapy through another source; 3. significant suicidal/homicidal risk that would need immediate intervention; 4. do not have ability complete Patient-Rated Outcome Measures (PROMs) either in person or remotely
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Adjustment Scale-6 (BASE-6) | Completed weekly through study completion, an average of 3 to 4 months | 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 |
| Patient Health Questionnaire-9 (PHQ-9) | Completed weekly through study completion, an average of 3 to 4 months | Evaluate depression symptoms Minimum score: 0 Maximum score: 27 A higher score indicates more severe depression/worse outcome |
| Generalized Anxiety Disorder-7 (GAD-7) | Completed weekly through study completion, an average of 3 to 4 months | evaluate anxiety symptoms Minimum score: 0 Maximum score: 21 A higher score indicates more severe anxiety/worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Quality of Life-Brief (WHOQOL-BREF) | Pre-post, through study completion, an average of 3 to 4 months | This is a self-report measure designed to assess an individual's quality of life and well-being across four domains, including physical health, psychological well-being, social relationships, and environmental conditions Minimum score: 0 Maximum score: 100 A higher score indicates a higher quality of life/better outcome |
| Working Alliance Inventory-Short Form Revised (WAI-SR) | Completed monthly, through study completion, an average of 3 to 4 months | The WAI-SR is a self-report measure of the strengths of the therapeutic alliance that clients perceive. Minimum score: 12 Maximum score: 60 A higher score indicates a stronger working alliance between the provider and the patient / better outcome |
| Vanderbilt Psychotherapy Process Scale - Patient version (VPPS) | Completed every 6 weeks; through study completion, an average of 3 to 4 months | The VPPS-P is a patient-report measure consisting of 42 items with five subscales, including therapist exploration, negative relationship, patient psychic distress, patient participation, therapist warmth and friendliness, and patient dependency. Minimum score: 42 Maximum score: 210 A higher score indicates better outcome |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVirginia O'Brien, MD
Carilion Clinic
Outcome results
None listed