DepressionNCT05274620
Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting
A study testing IntelliCare in people with Depression and Anxiety, run by Adaptive Health, Inc at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the implementation of IntelliCare as a frontline intervention within health care settings. 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?
- IntelliCare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2022to 30 Apr 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who have been identified as depressed or anxious by a care provider in one of the participating healthcare organizations.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Medicine Dept of Psychiatry
Chicago, Illinois, 60611
MacLeod HealthCare
Florence, South Carolina, 29506
About this study
The purpose of this study is to evaluate the implementation of IntelliCare as a frontline intervention within health care settings.
Read the detailed description
This study will evaluate the implementation of IntelliCare in two settings: Primary care in the McLeod Health system, serving a rural population where mental healthcare workers are scarce, and Northwestern Medicine's Department of Psychiatry, which currently has a 9-month waitlist for psychological services.
- Conditions
- Depression, Anxiety
- Being tested
- IntelliCare
- 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.
IntelliCareBehavioural
A mobile intervention that use principles of computerized therapy to decrease symptoms of depression
| Study group | Role | What they receive |
|---|---|---|
| IntelliCare | Other | 8 weeks of IntelliCare Receives: Behavioral: IntelliCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
- Number of eligible patients during trial period; 2) number offered IntelliCare; 3) number initiating IntelliCare; 4) number completing IntelliCare
Measured: 5 months
Cost
Cost of delivering IntelliCare per patient
Measured: 7 months
Secondary outcomes (1)
Depression
Patient Health Questionnaire-9 (PHQ-9); higher scores indicate greater symptom severity
Measured: Administered weekly over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 May 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptive Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carolyn MacIver, Principal investigator, Adaptive Health, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274620
- Sponsor's protocol ID
- R44MH114725-05
- Status last verified
- Jul 2024
- First submitted
- 2 Mar 2022
- Last updated
- 31 Jul 2024
- Results posted
- 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting
- ClinicalTrials.gov ID
- NCT05274620
- Acronym / sponsor ID
- R44MH114725-05
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Adaptive Health, IncIndustry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 10 Mar 2022 (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 purpose of this study is to evaluate the implementation of IntelliCare as a frontline intervention within health care settings.
Detailed description
This study will evaluate the implementation of IntelliCare in two settings: Primary care in the McLeod Health system, serving a rural population where mental healthcare workers are scarce, and Northwestern Medicine's Department of Psychiatry, which currently has a 9-month waitlist for psychological services.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IntelliCare | Other | Behavioral: IntelliCare8 weeks of IntelliCare |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who have been identified as depressed or anxious by a care provider in one of the participating healthcare organizations.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| IntelliCareA mobile intervention that use principles of computerized therapy to decrease symptoms of depression | Behavioural | IntelliCare |
Primary outcome
Reach
Time frame: 5 months
1. Number of eligible patients during trial period; 2) number offered IntelliCare; 3) number initiating IntelliCare; 4) number completing IntelliCare
Cost
Time frame: 7 months
Cost of delivering IntelliCare per patient
1 secondary outcome
Depression
Time frame: Administered weekly over 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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.
Carolyn MacIver principal investigator
Adaptive Health, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IntelliCare in people with Depression and Anxiety, run by Adaptive Health, Inc at 2 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reach (time frame: 5 months). 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 31 Jul 2024.