DepressionNCT06556589
Collaborative Care for Treatment of Depression and Anxiety
An observational study of Depression and Anxiety, run by Kaiser Permanente at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with depression and/or anxiety.
Who may be able to join
- 18+
- 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.
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- 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
Who cannot join
- Exclude individuals with any of the following diagnoses:
- Psychosis
- Dementia
- Bipolar
- Personality Disorders
- Post Traumatic Stress Disorder (PTSD)
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- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Cognitive Disorder
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kaiser Permanente Colorado
Aurora, Colorado, 80011
Arne Beck, PhD, 720-989-5181, Arne.Beck@kp.org
Erica Morse, MA, 720-978-5214, Erica.F.Morse@kp.org
About this study
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.
Read the detailed description
We will answer the question: does a collaborative care model in primary care clinics improve outcomes for patients with depression and/or anxiety? Specific components of the model include:
- Patient-centered team care - virtual care management to support patient outreach, follow-up, and navigation to appropriate care settings, based on patient risk. Shared care plans with primary care and behavioral health providers, with a focus on patient preferences (e.g., short-term therapy, medications, or both) and fostering engagement in treatment.
- Population-based care - Automated workflows for population-based outreach with the Patient Health Questionnaire 9-item (PHQ9) and Generalized Anxiety Disorder 7-item (GAD7) questionnaires after diagnosis and treatment initiation for more accurate and comprehensive assessment of patient improvement. This also includes automating risk-based routing of PHQ9 results to the collaborative care team to triage patients into the most appropriate care settings and developing similar automated risk-based routing procedures for GAD7 results.
- Measurement-based treatment to target - provide short-term psychotherapy and/or pharmacotherapy with a focus on measuring treatment response with the PHQ9 and/or GAD7 to guide treatment adjustments.
- Evidence-based care - provide short-term Problem-Solving Treatment-Primary Care (PST-PC), Behavioral Activation (BA), and/or medications shown to be effective for patients in primary care settings. These evidence-based interventions will include patient engagement strategies and be applicable to diverse patient populations.
- Accountable care - The collaborative care provider team will be accountable for quality of care and clinical outcomes for the patients they serve, not just the volume of care provided.
A cluster randomized design will be used to compare depression and anxiety outcomes for at least two randomly selected KPCO primary care clinics that implement collaborative care to those clinics that provide care as usual. This design will allow us to study the effectiveness of the collaborative care model and its potential for dissemination across Kaiser Permanente regions.
- Conditions
- Depression, Anxiety
- Being tested
- Collaborative Care
- Keywords
- Collaborative Care, Depression, Anxiety, Evaluation
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative CareBehavioural
Collaborative care components include patient-centered team care, population-based care, measurement-based treatment to target, evidence-based care, and accountable care.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care offered | Implement collaborative care in at least 2 clinic locations for patients with depression and/or anxiety using population-based outreach using electronic health record tools and provider referral, and tracking outcomes in the medical record. Receives: Behavioral: Collaborative Care | |
| No Collaborative Care offered | Provide care as usual for patients with depression and/or anxiety at all other KPCO clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire 9-item (PHQ-9) score
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.
Measured: Baseline and up to 24 weeks
Generalized Anxiety Disorder 7-item (GAD-7)
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.
Measured: Baseline and up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Mar 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Garfield Memorial Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556589
- Sponsor's protocol ID
- 2066851
- Other IDs
- RNG212361
- Status last verified
- Aug 2024
- First submitted
- 12 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care for Treatment of Depression and Anxiety
- ClinicalTrials.gov ID
- NCT06556589
- Acronym / sponsor ID
- 2066851
- Conditions
- Depression, Anxiety
- Keywords
- Collaborative Care, Depression, Anxiety, Evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Garfield Memorial Fund
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 16 Aug 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.
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.
Detailed description
We will answer the question: does a collaborative care model in primary care clinics improve outcomes for patients with depression and/or anxiety? Specific components of the model include:
- Patient-centered team care - virtual care management to support patient outreach, follow-up, and navigation to appropriate care settings, based on patient risk. Shared care plans with primary care and behavioral health providers, with a focus on patient preferences (e.g., short-term therapy, medications, or both) and fostering engagement in treatment.
- Population-based care - Automated workflows for population-based outreach with the Patient Health Questionnaire 9-item (PHQ9) and Generalized Anxiety Disorder 7-item (GAD7) questionnaires after diagnosis and treatment initiation for more accurate and comprehensive assessment of patient improvement. This also includes automating risk-based routing of PHQ9 results to the collaborative care team to triage patients into the most appropriate care settings and developing similar automated risk-based routing procedures for GAD7 results.
- Measurement-based treatment to target - provide short-term psychotherapy and/or pharmacotherapy with a focus on measuring treatment response with the PHQ9 and/or GAD7 to guide treatment adjustments.
- Evidence-based care - provide short-term Problem-Solving Treatment-Primary Care (PST-PC), Behavioral Activation (BA), and/or medications shown to be effective for patients in primary care settings. These evidence-based interventions will include patient engagement strategies and be applicable to diverse patient populations.
- Accountable care - The collaborative care provider team will be accountable for quality of care and clinical outcomes for the patients they serve, not just the volume of care provided.
A cluster randomized design will be used to compare depression and anxiety outcomes for at least two randomly selected KPCO primary care clinics that implement collaborative care to those clinics that provide care as usual. This design will allow us to study the effectiveness of the collaborative care model and its potential for dissemination across Kaiser Permanente regions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care offered | – | Behavioral: Collaborative CareImplement collaborative care in at least 2 clinic locations for patients with depression and/or anxiety using population-based outreach using electronic health record tools and provider referral, and tracking outcomes in the medical record. |
| No Collaborative Care offered | – | –Provide care as usual for patients with depression and/or anxiety at all other KPCO clinics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with depression and/or anxiety.
Key inclusion criteria (13 listed)
- 18+
- Current membership and active on patient portal
- Depression Diagnosis in the prior year
- Overdue for PHQ9 Screening based on the following criteria:
- Anxiety diagnoses in the prior year
Key exclusion criteria (9 listed)
- Exclude individuals with any of the following diagnoses:
- Psychosis
- Dementia
- Bipolar
- Personality Disorders
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 |
|---|---|---|
| Collaborative CareCollaborative care components include patient-centered team care, population-based care, measurement-based treatment to target, evidence-based care, and accountable care. | Behavioural | Collaborative Care offered |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Kaiser Permanente 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 13 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arne Beck, PhD (720-989-5181, Arne.Beck@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire 9-item (PHQ-9) score (time frame: Baseline and up to 24 weeks). The study lists 2 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 16 Aug 2024.