Psychotherapy for Depression and Anxiety Disorders
(MBC Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Carilion Clinic
Disqualifiers: Acute psychosis, Intellectual disability, Neurocognitive disorders, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on psychotherapy, so you may not need to change your medication routine, but it's best to confirm with the trial organizers.
What data supports the effectiveness of the treatment Measurement-Based Care, Routine Outcome Monitoring, Evidence-Based Practice for depression and anxiety disorders?
Research shows that using Measurement-Based Care (MBC), which involves regularly collecting and using patient data to guide treatment, can improve outcomes for patients with depression and anxiety. Studies indicate that MBC helps reduce symptom deterioration and increases recovery rates by providing timely feedback to therapists, allowing them to adjust treatment plans effectively.
12345Is psychotherapy for depression and anxiety generally safe for humans?
Research suggests that using feedback methods in psychotherapy can reduce negative outcomes and improve recovery rates, indicating a focus on safety and monitoring during treatment.
12367How is Measurement-Based Care different from other treatments for depression and anxiety?
Measurement-Based Care (MBC) is unique because it involves regularly collecting and using patient data throughout treatment to guide clinical decisions, which helps improve treatment outcomes by identifying and addressing issues early. This approach is flexible and can be integrated into any therapy, making it adaptable to individual patient needs and enhancing the effectiveness of existing treatments.
13589Eligibility Criteria
This trial is for adults with Generalized Anxiety Disorder or Depression who are seeking treatment. Participants should be willing to attend weekly therapy sessions for three months and can't already be receiving measurement-based care.Inclusion Criteria
I am seeking therapy for depression or anxiety with specific test scores.
I am 18 years old or older.
Exclusion Criteria
Significant suicidal/homicidal risk that would need immediate intervention
I cannot complete health surveys on my own.
Currently receiving psychotherapy through another source
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive weekly individual psychotherapy sessions for 12 sessions in total
12 weeks
12 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the effectiveness of Measurement-Based Care (MBC) in treating anxiety and depression compared to usual care. It involves a randomized control trial where participants receive either MBC, standard treatment, or are placed on a waitlist.
3Treatment groups
Experimental Treatment
Active Control
Group I: Measurement-based care groupExperimental Treatment1 Intervention
Measurement-based care group
Group II: Treatment-as-Usual groupActive Control1 Intervention
Treatment-as-Usual group
Group III: Waitlist control groupActive Control1 Intervention
Waitlist control group
Measurement-Based Care is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Measurement-Based Care for:
- Adult Behavioral Health
- Mental Health Conditions
🇪🇺 Approved in European Union as Measurement-Based Care for:
- Behavioral Health
- Mental Health Disorders
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Carilion Mental HealthRoanoke, VA
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Who Is Running the Clinical Trial?
Carilion ClinicLead Sponsor
Virginia Polytechnic Institute and State UniversityCollaborator
References
Maximizing Psychotherapy Outcome beyond Evidence-Based Medicine. [2017]Despite evidence that psychotherapy has a positive impact on psychological disorders, 30% of patients fail to respond during clinical trials, and as many as 65% of patients in routine care leave treatment without a measured benefit. In addition, therapists appear to overestimate positive outcomes in their patients relative to measured outcomes and are particularly poor at identifying patients at risk for a negative outcome. These problems suggest the need for measuring and monitoring patient treatment response over the course of treatment while applying standardized methods of identifying at-risk cases. Computer-assisted methods for measuring, monitoring, identifying potential deteriorators, and providing feedback to clinicians are described along with a model that explains why feedback is likely to be beneficial to patients. The results of 12 clinical trials are summarized and suggest that deterioration rates can be substantially reduced in at-risk cases (from baseline rates of 21% down to 13%) and that recovery rates are substantially increased in this subgroup of cases (from a baseline of 20% up to 35%) when therapists are provided this information. When problem-solving methods are added to feedback, deterioration in at-risk cases is further reduced to 6% while recovery/improvement rates rise to about 50%. It is suggested that the feedback methods become a standard of practice. Such a change in patterns of care can be achieved through minimal modification to routine practice but may require discussions with patients about their clinical progress.
Outcome measures for practice. [2015]The current review targets efforts to use outcome measures in routine care for the purpose of enhancing psychotherapy outcome, particularly for patients who are predicted to have a negative treatment outcome. The place of outcome measures in solving the negative effects problem is emphasized, with a narrow focus on one set of measures that is relatively well advanced in its clinical utility. This clinical innovation relies on research-based clinical decision tools that provide psychotherapists with timely warnings and problem-solving strategies when a patient deviates from an expected treatment response. Summary of a meta-analytic review using this patient feedback methodology suggests that measuring, monitoring, predicting treatment failure, and providing clinical support tools to clinicians enhance treatment outcome for patients who have an early negative treatment response. Other measures are then briefly reviewed before we turn to future directions. Clinicians are encouraged to employ these methods in routine practice.
Standardized Versus Tailored Implementation of Measurement-Based Care for Depression in Community Mental Health Clinics. [2023]Measurement-based care (MBC) is an evidence-based practice that is rarely integrated into psychotherapy. The authors sought to determine whether tailored MBC implementation can improve clinician fidelity and depression outcomes compared with standardized implementation.
Characterizing measurement-based care implementation using therapist report. [2023]The effectiveness of measurement-based care (MBC), an evidence-based practice that uses regularly collected assessment data to guide clinical decision-making, is impacted by whether and how therapists use information from MBC tools in treatment. Improved characterization of how therapists use MBC in treatment sessions with youth is needed to guide implementation and understand variability in MBC effectiveness. To meet this need, this study examined therapists' sharing and discussion of MBC in treatment sessions. Thirty therapists were randomly assigned to the MBC condition as part of a comparative effectiveness trail of treatments for adolescent anxiety and depression. A qualitative content analysis was conducted on therapists' written explanations of changes made to the session based on the MBC data. Therapists reported sharing data with youth and caregivers in an average of 34.6% and 27.4% of sessions, respectively. Therapists reported incorporating MBC data in an average of 21.1% of sessions. When data were used, therapists predominately focused changes on short-term (e.g., current symptoms, treatment skill) rather than long-term (e.g., symptom progress, treatment goals) decision-making. Therapists inconsistently used MBC data, highlighting the need for improved training in and monitoring of how therapists use MBC in session to guide collaborative treatment decision-making with youth and caregivers.
Using Measurement-Based Care to Enhance Any Treatment. [2020]Measurement-based care (MBC) can be defined as the practice of basing clinical care on client data collected throughout treatment. MBC is considered a core component of numerous evidence-based practices (e.g., Beck & Beck, 2011; Klerman, Weissman, Rounsaville, & Chevron, 1984) and has emerging empirical support as an evidence-based framework that can be added to any treatment (Lambert et al., 2003, Trivedi et al., 2007). The observed benefits of MBC are numerous. MBC provides insight into treatment progress, highlights ongoing treatment targets, reduces symptom deterioration, and improves client outcomes (Lambert et al., 2005). Moreover, as a framework to guide treatment, MBC has transtheoretical and transdiagnostic relevance with broad reach across clinical settings. Although MBC has primarily focused on assessing symptoms (e.g., depression, anxiety), MBC can also be used to assess valuable information about (a) symptoms, (b) functioning and satisfaction with life, (c) putative mechanisms of change (e.g., readiness to change), and (d) the treatment process (e.g., session feedback, working alliance). This paper provides an overview of the benefits and challenges of MBC implementation when conceptualized as a transtheoretical and transdiagnostic framework for evaluating client therapy progress and outcomes across these four domains. The empirical support for MBC use is briefly reviewed, an adult case example is presented to serve as a guide for successful implementation of MBC in clinical practice, and future directions to maximize MBC utility are discussed.
Feedback-informed treatment versus usual psychological treatment for depression and anxiety: a multisite, open-label, cluster randomised controlled trial. [2019]Previous research suggests that the use of outcome feedback technology can enable psychological therapists to identify and resolve obstacles to clinical improvement. We aimed to assess the effectiveness of an outcome feedback quality assurance system applied in stepped care psychological services.
Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]Adverse event monitoring in studies of psychotherapy is crucial to clinical decision-making, particularly for weighing of benefits and harms of treatment approaches. In this systematic review, we identified how adverse events are defined, measured, and reported in studies of psychosocial interventions for children with mental disorders.
Measurement and psychotherapy. Evidence-based practice and practice-based evidence. [2019]Measurement is the foundation of evidence-based practice. Advances in measurement procedures should extend to psychotherapy practice.
It's a Bird, It's A Plane, It's … Fidelity Measurement In the Real World. [2021]In psychotherapy research, fidelity instruments were originally developed as manipulation checks in experimental tests of treatment efficacy. The purposes of fidelity measurement are expanding as consumers, administrators, and payers seek to determine the extent to which the interventions purchased are actually received. Emerging purposes for fidelity measurement are described, as are challenges to developing a single instrument that can adequately meet multiple purposes, and that is both effective (psychometrically sound) and efficient (feasibly used in routine care). Examples are provided of efforts to balance these attributes of fidelity measurement, to measure fidelity at multiple levels of the practice context, and to index and evaluate the effects of additional program parameters on client outcomes in routine care.