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Behavioral Intervention

Psychotherapy for Depression and Anxiety Disorders (MBC Trial)

N/A
Recruiting
Led By Virginia O'Brien, MD
Research Sponsored by Carilion Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Be older than 18 years old
Must not have
Do not have the ability to complete Patient-Rated Outcome Measures (PROMs) either in person or remotely
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completed every 6 weeks; through study completion, an average of 3 to 4 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the benefits and effectiveness of using measurement-based care (MBC) in adult behavioral health. The researchers will compare three groups: one receiving MBC, one receiving usual treatment,

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves psychotherapy, there may not be direct physical side effects like with medication; however, some individuals might experience emotional discomfort or distress as they work through personal issues during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am seeking therapy for depression or anxiety with specific test scores.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot complete health surveys on my own.
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I do not have severe mental or physical conditions that would prevent me from participating.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-post, through study completion, an average of 3 to 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-post, through study completion, an average of 3 to 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brief Adjustment Scale-6 (BASE-6)
Generalized Anxiety Disorder-7 (GAD-7)
Patient Health Questionnaire-9 (PHQ-9)
Secondary study objectives
Vanderbilt Psychotherapy Process Scale - Patient version (VPPS)
Working Alliance Inventory-Short Form Revised (WAI-SR)
World Health Organization Quality of Life-Brief (WHOQOL-BREF)
Other study objectives
Clinical Global Impressions - Improvement (CGI-I)
Clinical Global Impressions - Severity of Illness (CGI-S)
Patient Attitudes with and Satisfaction towards Measurement-Based Care (PAS-MBC)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychotherapy
2014
Completed Phase 3
~3440

Find a Location

Who is running the clinical trial?

Carilion ClinicLead Sponsor
82 Previous Clinical Trials
15,283 Total Patients Enrolled
Virginia Polytechnic Institute and State UniversityOTHER
156 Previous Clinical Trials
25,655 Total Patients Enrolled
Virginia O'Brien, MDPrincipal InvestigatorCarilion Clinic
1 Previous Clinical Trials
148 Total Patients Enrolled
~40 spots leftby Dec 2025