Evaluation of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program (ADAPT)

February 28, 2023 updated by: Kaiser Permanente

Evaluating the Implementation and Outcomes of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Collaborative Care Program in A Large, Integrated Healthcare System: A Mixed Methods Observational Study Protocol

Depression and anxiety are increasingly common conditions for which primary care providers (PCPs) serve as the initial healthcare contact for most patients. Comorbid depression and anxiety result in higher costs, and treatment as usual, which is referrals to specialty psychiatric care, often contribute to delays in care. Collaborative psychiatric care is an evidence-based strategy to increase mental healthcare access while reducing costs. ADAPT is a novel collaborative care model. By using technology-driven appointments with providers, ADAPT increases access to mental healthcare, and reduces member wait times. This mixed methods study will assess implementation measures of the ADAPT program and the components of ADAPT related to patient mental health improvement compared to specialty mental health care. The hypothesis is that: ADAPT program will have good program reach and efficacy. We will examine program implementation and maintenance. Further, the study looks to uncover member and program characteristics that are associated with depression and anxiety remission and care utilization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • Kaiser Permanente Northern California Division of Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Kaiser Permanente Northern California adult members who screen positive for depression or anxiety in primary care and are referred to treatment.

Description

Inclusion Criteria:

  • Adult Outcomes Questionnaire (AOQ) score between 10-30
  • English-Speaking

Exclusion Criteria:

  • High risk for suicide defined by answer to question 9 on PHQ-9 of 1 or more
  • Diagnosis of bipolar disorder
  • Diagnosis of a psychotic disorder
  • Dementia diagnosis
  • Active substance use disorder diagnosis
  • Current hospice
  • Current home-based palliative care
  • Residing in a skilled nursing facility
  • Residing in an assisted living facility
  • Non-Kaiser Permanente Member
  • Established psychiatric care outside of Kaiser Permanente

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control
Patients receiving referral to specialty mental healthcare
ADAPT
Behavioral: ADAPT
The Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program is a novel collaborative psychiatric care model that is designed to unburden PCPs and psychiatrists, increase access to quality specialty mental healthcare for Kaiser Permanente members, and improve patient depression and anxiety treatment outcomes by utilizing technology-driven appointments. This program uses principles of collaborative care, including patient-centered care, population-based care, evidence-based care, measurement-based treatment to target, and accountable care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient reach
Time Frame: through study completion, 2 years
Examine and compare patients eligible and enrolled in ADAPT versus those eligible but not enrolled in ADAPT
through study completion, 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Member characteristics associated with depression remission
Time Frame: baseline, 3 and 6 months
Clinical variables important to predicting intervention response: Patient demographics (age, sex, race/ethnicity, socioeconomic status), behavioral characteristics (exercise, sleep), and other individual characteristics (comorbidities, adverse childhood experiences, social supports, resilience).
baseline, 3 and 6 months
Member characteristics associated with anxiety remission
Time Frame: baseline, 3 and 6 months
Clinical variables important to predicting intervention response: Patient demographics (age, sex, race/ethnicity, socioeconomic status), behavioral characteristics (exercise, sleep), and other individual characteristics (comorbidities, adverse childhood experiences, social supports, resilience).
baseline, 3 and 6 months
Efficacy: Patient therapy engagement
Time Frame: baseline, 3 and 6 months
number of therapy contacts (individual, group and combined)
baseline, 3 and 6 months
Efficacy: Patient medication provider engagement
Time Frame: baseline, 3 and 6 months
number of clinical pharmacy contacts
baseline, 3 and 6 months
Efficacy: Patient medication engagement
Time Frame: baseline, 3 and 6 months
medication length of treatment
baseline, 3 and 6 months
Efficacy: Patient psychiatry engagement
Time Frame: baseline, 3 and 6 months
number of contact with psychiatrist
baseline, 3 and 6 months
Efficacy: Patient time to care
Time Frame: baseline, 3 and 6 months
average time from ADAPT referral to first appointment with therapist or pharmacist
baseline, 3 and 6 months
Efficacy: Depression outcomes
Time Frame: baseline, 3 and 6 months
Examine if patients enrolled in ADAPT demonstrate non-inferior depression outcomes defined by change in the patient health questionnaire (PHQ-9) score compared to treatment as usual.
baseline, 3 and 6 months
Efficacy: Anxiety outcomes
Time Frame: baseline, 3 and 6 months
Examine if patients enrolled in ADAPT demonstrate non-inferior anxiety outcomes defined by generalized anxiety disorder (GAD-2) score compared to treatment as usual.
baseline, 3 and 6 months
Efficacy: Time to clinical improvement
Time Frame: baseline, 3 and 6 months
Compare time to clinical improvement as defined by change in Adult Outcomes Questionnaire (AOQ score) from baseline to 3, and 6 months for members in ADAPT compared to treatment as usual.
baseline, 3 and 6 months
Implementation: measurement-based care
Time Frame: through study completion, 2 years
Examine provider use of measurement-based care
through study completion, 2 years
Implementation: Diagnosis
Time Frame: through study completion, 2 years
Examine provider use of a specific depression or anxiety diagnosis
through study completion, 2 years
Maintenance: Measurement-based care
Time Frame: through study completion, 2 years
Examine provider use of measurement-based care over time
through study completion, 2 years
Maintenance: Diagnosis
Time Frame: through study completion, 2 years
Examine provider use of a specific depression or anxiety diagnosis over time
through study completion, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaiser Permanente

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kathryn K Erickson-Ridout, MD PhD, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1421043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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