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| Name | Class |
|---|---|
| Virginia Polytechnic Institute and State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Measurement-based care group | Experimental | Measurement-based care group |
|
| Treatment-as-Usual group | Active Comparator | Treatment-as-Usual group |
|
| Waitlist control group | No Intervention | Waitlist control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychotherapy | Behavioral | Individual psychotherapy for weekly 12-sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization Quality of Life-Brief (WHOQOL-BREF) | 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 | Pre-post, through study completion, an average of 3 to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions - Severity of Illness (CGI-S) | Clinical impressions of the clinician's view on the client's global functioning, the overall severity of symptoms (CGI-S) Minimum score: 1 Maximum score: 7 A higher score indicates more severe impairment/worse outcome | Pre-post, through study completion, an average of 3 to 4 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia O'Brien, MD | Carilion Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carilion Mental Health | Roanoke | Virginia | 24018 | United States |
Due to the need to protect patient confidentiality and privacy regarding identifiable health data
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
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| Working Alliance Inventory-Short Form Revised (WAI-SR) | 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 | Completed monthly, through study completion, an average of 3 to 4 months |
| Vanderbilt Psychotherapy Process Scale - Patient version (VPPS) | 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 | Completed every 6 weeks; through study completion, an average of 3 to 4 months |
| Patient's Global Impressions of Severity (PGI-S) |
As CGI-S, the PGI-S is a 1-item global impression questionnaires that allow patients to report their own views on the severity of ongoing symptoms based on a 7-point scale Minimum score: 1 Maximum score: 7 A higher score indicates more severe impairment/worse outcome |
| Pre-post, through study completion, an average of 3 to 4 months |
| Clinical Global Impressions - Improvement (CGI-I) | Clinical impressions of the client's improvement level that the client shows throughout the therapy (CGI-I) Minimum score: 1 Maximum score: 7 A lower score indicates better outcome | Through study completion, an average of 3 to 4 months |
| Patient Global Impressions - Improvement (PGI-I) | PGI-S is a 1-item global impression questionnaires that allow patients to report their own views on the response and improvement to intervention based on a 7-point scale Minimum score: 1 Maximum score: 7 A lower score indicates better outcome | Through study completion, an average of 3 to 4 months |
| Patient Attitudes with and Satisfaction towards Measurement-Based Care (PAS-MBC) | A 12-item tailored questionnaire was created to fully capture clients' attitudes towards and experience with measurement-based care during their treatment. Minimum value: 12 Maximum value: 60 Higher score indicates better outcome/more positive attitudes toward measurement-based care | Through study completion, an average of 3 to 4 months |