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

Withdrawn

Conditions

Intervention / Treatment

Study Type

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 Locations

    • 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

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
Intervention / Treatment
Control
Patients receiving referral to specialty mental healthcare
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

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

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.

Investigators

  • 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)

April 1, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID 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.

Clinical Trials on Depression

Clinical Trials on ADAPT

3
Subscribe