DepressionADAPTNCT04839718
Evaluation of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program
An observational study of Depression and Anxiety, run by Kaiser Permanente at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- ADAPT
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 31 Dec 2022
- 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
- Adult, Older adult
Study population: Kaiser Permanente Northern California adult members who screen positive for depression or anxiety in primary care and are referred to treatment.
Who may be able to join
- Adult Outcomes Questionnaire (AOQ) score between 10-30
- English-Speaking
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Northern California Division of Research
Oakland, California, 94612
About this study
Official title: 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.
- Conditions
- Depression, Anxiety
- Being tested
- ADAPT
- Keywords
- Depression, Anxiety
- 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.
ADAPTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients receiving referral to specialty mental healthcare | |
| ADAPT | ADAPT Receives: Behavioral: ADAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reach
Examine and compare patients eligible and enrolled in ADAPT versus those eligible but not enrolled in ADAPT
Measured: through study completion, 2 years
Secondary outcomes (14)
Member characteristics associated with depression remission
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).
Measured: baseline, 3 and 6 months
Member characteristics associated with anxiety remission
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).
Measured: baseline, 3 and 6 months
Efficacy: Patient therapy engagement
number of therapy contacts (individual, group and combined)
Measured: baseline, 3 and 6 months
Efficacy: Patient medication provider engagement
number of clinical pharmacy contacts
Measured: baseline, 3 and 6 months
Efficacy: Patient medication engagement
medication length of treatment
Measured: baseline, 3 and 6 months
Efficacy: Patient psychiatry engagement
number of contact with psychiatrist
Measured: baseline, 3 and 6 months
Efficacy: Patient time to care
average time from ADAPT referral to first appointment with therapist or pharmacist
Measured: baseline, 3 and 6 months
Efficacy: Depression outcomes
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.
Measured: baseline, 3 and 6 months
Efficacy: Anxiety outcomes
Examine if patients enrolled in ADAPT demonstrate non-inferior anxiety outcomes defined by generalized anxiety disorder (GAD-2) score compared to treatment as usual.
Measured: baseline, 3 and 6 months
Efficacy: Time to clinical improvement
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.
Measured: baseline, 3 and 6 months
Implementation: measurement-based care
Examine provider use of measurement-based care
Measured: through study completion, 2 years
Implementation: Diagnosis
Examine provider use of a specific depression or anxiety diagnosis
Measured: through study completion, 2 years
Maintenance: Measurement-based care
Examine provider use of measurement-based care over time
Measured: through study completion, 2 years
Maintenance: Diagnosis
Examine provider use of a specific depression or anxiety diagnosis over time
Measured: through study completion, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Apr 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Study redesigned to be a data-only cohort study and not a clinical trial prior to any patient recruitment activities.
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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn K Erickson-Ridout, MD PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839718
- Sponsor's protocol ID
- 1421043
- Acronym
- ADAPT
- Status last verified
- Feb 2023
- First submitted
- 29 Mar 2021
- Last updated
- 2 Mar 2023
- 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 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04839718
- Acronym / sponsor ID
- ADAPT / 1421043
- Conditions
- Depression, Anxiety
- Keywords
- Depression, Anxiety
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study redesigned to be a data-only cohort study and not a clinical trial prior to any patient recruitment activities.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Apr 2021 (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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Patients receiving referral to specialty mental healthcare |
| ADAPT | – | Behavioral: ADAPTADAPT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Kaiser Permanente Northern California adult members who screen positive for depression or anxiety in primary care and are referred to treatment.
Key inclusion criteria (2 listed)
- Adult Outcomes Questionnaire (AOQ) score between 10-30
- English-Speaking
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| ADAPTThe 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. | Behavioural | ADAPT |
Primary outcome
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
14 secondary outcomes
Member characteristics associated with depression remission
Time frame: baseline, 3 and 6 months
Member characteristics associated with anxiety remission
Time frame: baseline, 3 and 6 months
Efficacy: Patient therapy engagement
Time frame: baseline, 3 and 6 months
Efficacy: Patient medication provider engagement
Time frame: baseline, 3 and 6 months
Efficacy: Patient medication engagement
Time frame: baseline, 3 and 6 months
Efficacy: Patient psychiatry engagement
Time frame: baseline, 3 and 6 months
Efficacy: Patient time to care
Time frame: baseline, 3 and 6 months
Efficacy: Depression outcomes
Time frame: baseline, 3 and 6 months
Efficacy: Anxiety outcomes
Time frame: baseline, 3 and 6 months
Efficacy: Time to clinical improvement
Time frame: baseline, 3 and 6 months
Implementation: measurement-based care
Time frame: through study completion, 2 years
Implementation: Diagnosis
Time frame: through study completion, 2 years
Maintenance: Measurement-based care
Time frame: through study completion, 2 years
Maintenance: Diagnosis
Time frame: through study completion, 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- 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.
Kathryn K Erickson-Ridout, MD PhD principal investigator
Kaiser Permanente
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 2 inclusion and 11 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: withdrawn, as of the sponsor's last update on 2 Mar 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reach (time frame: through study completion, 2 years). 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 2 Mar 2023.