NCT06556589 · Kaiser Permanente
Collaborative Care for Treatment of Depression and Anxiety
What this study is about
The goal of this project is to evaluate the effectiveness of a collaborative care model for primary care patients at Kaiser Permanente Colorado (KPCO) with depression and/or anxiety. Collaborative care uses evidence-based short-term treatments delivered to patients over the phone.
View original scientific description
The goal of this project is to evaluate the effectiveness of a collaborative care model for primary care patients at Kaiser Permanente Colorado (KPCO) with depression and/or anxiety. Collaborative care uses evidence-based short-term treatments delivered to patients over the phone. We will explore the use of cost-efficient automated processes for patient outreach and follow-up, such as care pools of patients and using patient portal messaging, risk-based results routing to providers, and electronic health record (EHR) tools for patient tracking and outcome assessment. Using a cluster randomized design, we will compare results between clinics that are offering collaborative care to those that are not.
Interventions
BEHAVIORAL
Collaborative Care
Collaborative care components include patient-centered team care, population-based care, measurement-based treatment to target, evidence-based care, and accountable care.
Primary outcome measures
Patient Health Questionnaire 9-item (PHQ-9) score
Time frame: Baseline and up to 24 weeks
Change in Patient Health Questionnaire 9-item (PHQ-9) scores before and after Collaborative Care intervention. The score ranges from 0 to 27, with lower numbers indicating improvement in depression symptoms.
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: Baseline and up to 24 weeks
Generalized Anxiety Disorder 7-item (GAD-7) questionnaire scores before and after Collaborative Care intervention. The score ranges from 0 to 21, with lower numbers indicating improvement in anxiety symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Current membership and active on patient portal
- Depression Diagnosis in the prior year
- Overdue for PHQ9 Screening based on the following criteria:
- High Risk: Last PHQ9 screener was completed greater than 4 months ago AND total Score is greater than or equal 10 or item 9 is greater than 0.
- Low Risk: Last PHQ9 screener was completed greater than 12 months ago AND Last PHQ9 Total Score is less than 10 and item 9 is equal to 0.
- Anxiety diagnoses in the prior year
- Has a baseline GAD7 in the same prior year; score = 10+ (\*Note: Provider referrals could be GAD7 score of 7 or higher)
- No Behavioral Health (BH) engagement in the prior year
- Patient is not in a Skilled Nursing Facility or Hospice
- Patient has no record of psychiatric hospitalization in the last year
- Patient does not need an interpreter (i.e., English speaking)
- Primary care location is one of the intervention clinics
Exclusion criteria
- • Exclude individuals with any of the following diagnoses:
- Personality Disorders
- Post Traumatic Stress Disorder (PTSD)
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Cognitive Disorder
Where
- Aurora, Colorado
Collaborators
Garfield Memorial Fund
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 16, 2024 · Source of record for eligibility and locations