Depressive DisorderMBCNCT06671158
Measurement-Based Care (MBC) Implementation, Effectiveness, and Mechanisms of Change
A study testing Psychotherapy in people with Depressive Disorder and Anxiety Disorders, run by Carilion Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Anxiety Disorders
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2023to 16 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Effectiveness and Mechanisms of Change of Measurement Based Care for Depressive and Anxiety Disorders
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.
Read the 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.
- Conditions
- Depressive Disorder, Anxiety Disorders
- Being tested
- Psychotherapy
- Keywords
- measurement-based care, effectiveness, RCT, implementation, psychotherapy, mechanisms of change
- Medical subject headings
- Depressive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Individual psychotherapy for weekly 12-sessions
| Study group | Role | What they receive |
|---|---|---|
| Measurement-based care group | Experimental | Measurement-based care group Receives: Behavioral: Psychotherapy |
| Treatment-as-Usual group | Active comparator | Treatment-as-Usual group Receives: Behavioral: Psychotherapy |
| Waitlist control group | No intervention | Waitlist control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Completed weekly through study completion, an average of 3 to 4 months
Secondary outcomes (3)
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
Measured: Pre-post, through study completion, an average of 3 to 4 months
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
Measured: 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
Measured: Completed every 6 weeks; through study completion, an average of 3 to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start10 Oct 2023
- Primary completion2 Jun 2026
- Study completion16 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Principal investigator, Virginia O'Brien, Carilion Clinic
- Investigators
- Virginia O'Brien, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671158
- Sponsor's protocol ID
- IRB-23-1992
- Acronym
- MBC
- Status last verified
- Jun 2026
- First submitted
- 10 Oct 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to the need to protect patient confidentiality and privacy regarding identifiable health data
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effectiveness and Mechanisms of Change of Measurement Based Care for Depressive and Anxiety Disorders
- ClinicalTrials.gov ID
- NCT06671158
- Acronym / sponsor ID
- MBC / IRB-23-1992
- Conditions
- Depressive Disorder, Anxiety Disorders
- Keywords
- measurement-based care, effectiveness, RCT, implementation, psychotherapy, mechanisms of change
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 16 Sep 2026 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Measurement-based care group | Experimental | Behavioral: PsychotherapyMeasurement-based care group |
| Treatment-as-Usual group | Active comparator | Behavioral: PsychotherapyTreatment-as-Usual group |
| Waitlist control group | No intervention | –Waitlist control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychotherapyIndividual psychotherapy for weekly 12-sessions | Behavioural | Measurement-based care group, Treatment-as-Usual group |
Primary outcome
Brief Adjustment Scale-6 (BASE-6)
Time frame: 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)
Time frame: 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)
Time frame: 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
3 secondary outcomes
World Health Organization Quality of Life-Brief (WHOQOL-BREF)
Time frame: Pre-post, through study completion, an average of 3 to 4 months
Working Alliance Inventory-Short Form Revised (WAI-SR)
Time frame: Completed monthly, through study completion, an average of 3 to 4 months
Vanderbilt Psychotherapy Process Scale - Patient version (VPPS)
Time frame: Completed every 6 weeks; through study completion, an average of 3 to 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided. Due to the need to protect patient confidentiality and privacy regarding identifiable health data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia O'Brien, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Depressive Disorder and Anxiety Disorders, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Adjustment Scale-6 (BASE-6) (time frame: Completed weekly through study completion, an average of 3 to 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.