DepressionNCT03500536
Understanding the Efficacy of Mobile Apps as Intervention for Depression in Adults When Deployed as Part of Primary Care.
A study testing IntelliCare in people with Depression and Anxiety, run by Actualize Therapy at 1 site in United States.
Trial summary
The clinical study is meant to optimize the mobile intervention, to develop a robust implementation plan for the mobile intervention within primary care, and to conduct an effectiveness trial, randomizing 128 participants in order to understand effect on severity of depression and anxiety symptoms, cost-effectiveness… 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, Primary Health Care
- 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
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 4 Apr 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Positive screen on PHQ-9
Who cannot join
- Does not own or use a mobile smart phone
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Implementing an Innovative Suite of Mobile Applications for Depression and Anxiety
The clinical study is meant to optimize the mobile intervention, to develop a robust implementation plan for the mobile intervention within primary care, and to conduct an effectiveness trial, randomizing 128 participants in order to understand effect on severity of depression and anxiety symptoms, cost-effectiveness, and usability of mobile apps.
- Conditions
- Depression, Anxiety, Primary Health Care
- 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 suite of mobile apps that use principles of computerized therapy to decrease symptoms of depression.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist Control | No intervention | 8 weeks of treatment as usual followed by 8 weeks of IntelliCare treatment. |
| Experimental | Experimental | 8 weeks of IntelliCare treatment followed by 8 weeks of treatment as usual. Receives: Behavioral: IntelliCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of depression
Using the PHQ-9 screener
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start18 Jul 2018
- Primary completion4 Apr 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actualize Therapy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Arkansas
- Responsible party
- Principal investigator, Pauli Lieponis, Actualize Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500536
- Sponsor's protocol ID
- Main
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2018
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Graham AK, Greene CJ, Kwasny MJ, Kaiser SM, Lieponis P, Powell T, Mohr DC. Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Sep 1;77(9):906-914. doi: 10.1001/jamapsychiatry.2020.1011.
PubMed 32432695
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing an Innovative Suite of Mobile Applications for Depression and Anxiety
- ClinicalTrials.gov ID
- NCT03500536
- Acronym / sponsor ID
- Main
- Conditions
- Depression, Anxiety, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Actualize TherapyIndustry (pharma, biotech, devices)
- Collaborators
- University of Arkansas
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 18 Apr 2018 (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 clinical study is meant to optimize the mobile intervention, to develop a robust implementation plan for the mobile intervention within primary care, and to conduct an effectiveness trial, randomizing 128 participants in order to understand effect on severity of depression and anxiety symptoms, cost-effectiveness, and usability of mobile apps.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist Control | No intervention | –8 weeks of treatment as usual followed by 8 weeks of IntelliCare treatment. |
| Experimental | Experimental | Behavioral: IntelliCare8 weeks of IntelliCare treatment followed by 8 weeks of treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Positive screen on PHQ-9
Key exclusion criteria (1 listed)
- Does not own or use a mobile smart phone
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 suite of mobile apps that use principles of computerized therapy to decrease symptoms of depression. | Behavioural | Experimental |
Primary outcome
Symptoms of depression
Time frame: 8 weeks
Using the PHQ-9 screener
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 30 Apr 2019.
- Derived from this study: PubMed 32432695Graham AK, Greene CJ, Kwasny MJ, Kaiser SM, Lieponis P, Powell T, Mohr DC. Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Sep 1;77(9):906-914. doi: 10.1001/jamapsychiatry.2020.1011.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Actualize Therapy 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 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 30 Apr 2019. 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 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?
Symptoms of depression (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03500536, which also lists 1 linked publication.
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 30 Apr 2019.