Major Depressive DisorderNCT02948036
A Closed-loop Assessment and Treatment Platform for Unipolar Depression and Anxiety
A study testing Mobile-device, plasticity-based adaptive cognitive treatment in people with Major Depressive Disorder, run by Posit Science Corporation at 1 site in United States.
Trial summary
Specific Aim 1: Finalize development of the closed-loop strategy in the MMT application. Specific Aim 2: Evaluate the acceptability and feasibility of the MMT application with the target population to prepare for a large-scale efficacy trial. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Mobile-device, plasticity-based adaptive cognitive treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 11 May 2023
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participant must be 18 to 60 years of age.
- Participant must score ≥ 9 on the Patient Health Questionnaire-9 (PHQ-9).
- Participant taking antidepressants or engaged in psychotherapy will not be excluded. If potential participants are currently prescribed psychotropic medication, they must be on a clinically stable medication regimen for ≥ 6 weeks prior to screening, based on self-report or as verified by medical health records, when available and authorized.
- Participant must be a fluent English speaker.
- Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control and use a mobile device and/or computer as required to complete study activities.
- Participant must have access to wireless Internet connectivity.
- Participant must be willing to communicate with study staff via email.
Who cannot join
- Participant with unstable and/or untreated conditions that may affect cognition, including untreated substance abuse/dependence disorders, unmanaged cardiovascular disease, endocrine or neurologic disorder, epilepsy, brain injury, hospitalization within 6-weeks of enrollment, ongoing chemotherapy or other cancer treatment (e.g., radiation) .
- Participant with history or current DSM-5 diagnosis of psychosis, such as schizophrenia, schizoaffective disorder, delusion disorder, psychotic disorder NOS, bipolar disorder, substance abuse (<1 year), and/or mood congruent or mood incongruent psychotic features or disorders.
- Participant has a history or current diagnosis of dementia and/or scores less than a 14 (75%) on the UBACC.
- Participant with active suicidal ideations or behaviors within 2 months of screening.
- Participant that shows signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit. Such participants will have that visit re-scheduled; participants with this problem occurring more than once may be excluded and dropped at the discretion of the Principal Investigators.
- Participant has problems performing assessments or comprehending or following spoken instructions, or those with behaviors during screening or baseline visits that, in the judgment of the screening staff, are likely to present significant problems for the staff conducting assessments.
- Participant is enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study. However, participation in standard treatments (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable..
- Participant is using computer-based cognitive training programs or has used it within a month of the consent date.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Specific Aim 1: Finalize development of the closed-loop strategy in the MMT application.
Specific Aim 2: Evaluate the acceptability and feasibility of the MMT application with the target population to prepare for a large-scale efficacy trial.
Read the detailed description
Specific Aim 1: Investigators have recently constructed a beta version of the MMT application, comprised of the multi-modal assessment modules, several treatment modules and an initial version of the closed-loop algorithm to control treatment delivery. Utilizing the extensive experience in developing mobile assessment and treatment tools at Posit Science Corporation, the investigators will employ an iterative development process incorporating feedback from users (focus groups of patients with mood disorders), clinicians and scientists (project consultants) to achieve the following development goals: (1) Finalize MMT's closed-loop algorithm to incorporate all assessment modules and expand the existing triage approach; (2) Expand cognitive behavioral therapy (CBT) functions within the app; and (3) Expand in-app bi-directional communication feature between the clinician and user. At the completion of Specific Aim 1, the investigators will have a mobile app suitable for evaluation in a feasibility trial (Specific Aim 2).
Specific Aim 2: The investigators will conduct a single arm, open label feasibility field trial with 40 participants that meet criteria for Major Depressive Disorder (MDD). Participants will be asked to engage with the experimental cognitive treatment and spend up to six weeks engaged in 15 hours of cognitive training as an adjunct to their standard clinical treatment. The experimental cognitive treatment will be deployed as dictated by the closed loop predictive algorithm, with all patient data continuously accessible for remote monitoring by the attending clinicians, research staff and Principal Investigator at University of Minnesota, and research staff and Sponsor PI at Posit Science Corporation. Participants will be re-evaluated every two weeks during treatment use, and again at the expected time of completion of training, at 6 weeks, to evaluate changes in cognitive function. Participants will then stop using their assigned program for 6 weeks, and return for a follow-up assessment to evaluate the endurance of changes in cognitive function in the absence of further program use.
- Conditions
- Major Depressive Disorder
- Being tested
- Mobile-device, plasticity-based adaptive cognitive treatment
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile-device, plasticity-based adaptive cognitive treatmentOther
Also called MMT
This study employs a mobile-device delivered treatment program. Participants will be asked to use the assigned treatment program for approximately 30 minutes per session, up to seven sessions per week, over 6 weeks (42 total sessions).
| Study group | Role | What they receive |
|---|---|---|
| MMT | Experimental | Mobile-device, plasticity-based adaptive cognitive treatment Receives: Other: Mobile-device, plasticity-based adaptive cognitive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total score for depressive symptoms using Beck Depression Scale (BDI-II)
The Beck Depression Scale (BDI-II) is a self-report questionnaire that assesses depressive symptoms with a scoring range between 0-63.
Measured: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Secondary outcomes (4)
Change in total score for depressive symptoms using Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) is a self-report questionnaire that assesses the degree of depression severity with a scoring range between 0-27.
Measured: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Change in total score for anxiety symptoms using Generalized Anxiety Disorder (GAD-7)
The Generalized Anxiety Disorder (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder with a scoring range between 0-21.
Measured: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Change in total score for mood symptoms using Immediate Mood Scaler (IMS)
The Immediate Mood Scaler (IMS) is a clinical assessment that assesses momentary mood symptoms related to anxiety and depression with a scoring range between 22-181.
Measured: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Change in total score for quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) assesses the degree of enjoyment and satisfaction experienced in various areas of daily functioning with a scoring range between 0-70.
Measured: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start1 Oct 2017
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gamze Balci, MD, Principal investigator, University of Minnesota - Department of PsychiatryThomas Van Vleet, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948036
- Sponsor's protocol ID
- PSC-1011-16
- Other IDs
- 1R43MH111325
- Status last verified
- Jun 2023
- First submitted
- 14 Jul 2016
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Closed-loop Assessment and Treatment Platform for Unipolar Depression and Anxiety
- ClinicalTrials.gov ID
- NCT02948036
- Acronym / sponsor ID
- PSC-1011-16
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), University of Minnesota
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 28 Oct 2016 (estimated)
- 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.
Specific Aim 1: Finalize development of the closed-loop strategy in the MMT application.
Specific Aim 2: Evaluate the acceptability and feasibility of the MMT application with the target population to prepare for a large-scale efficacy trial.
Detailed description
Specific Aim 1: Investigators have recently constructed a beta version of the MMT application, comprised of the multi-modal assessment modules, several treatment modules and an initial version of the closed-loop algorithm to control treatment delivery. Utilizing the extensive experience in developing mobile assessment and treatment tools at Posit Science Corporation, the investigators will employ an iterative development process incorporating feedback from users (focus groups of patients with mood disorders), clinicians and scientists (project consultants) to achieve the following development goals: (1) Finalize MMT's closed-loop algorithm to incorporate all assessment modules and expand the existing triage approach; (2) Expand cognitive behavioral therapy (CBT) functions within the app; and (3) Expand in-app bi-directional communication feature between the clinician and user. At the completion of Specific Aim 1, the investigators will have a mobile app suitable for evaluation in a feasibility trial (Specific Aim 2).
Specific Aim 2: The investigators will conduct a single arm, open label feasibility field trial with 40 participants that meet criteria for Major Depressive Disorder (MDD). Participants will be asked to engage with the experimental cognitive treatment and spend up to six weeks engaged in 15 hours of cognitive training as an adjunct to their standard clinical treatment. The experimental cognitive treatment will be deployed as dictated by the closed loop predictive algorithm, with all patient data continuously accessible for remote monitoring by the attending clinicians, research staff and Principal Investigator at University of Minnesota, and research staff and Sponsor PI at Posit Science Corporation. Participants will be re-evaluated every two weeks during treatment use, and again at the expected time of completion of training, at 6 weeks, to evaluate changes in cognitive function. Participants will then stop using their assigned program for 6 weeks, and return for a follow-up assessment to evaluate the endurance of changes in cognitive function in the absence of further program use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MMT | Experimental | Other: Mobile-device, plasticity-based adaptive cognitive treatmentMobile-device, plasticity-based adaptive cognitive treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant must be 18 to 60 years of age.
- Participant must score ≥ 9 on the Patient Health Questionnaire-9 (PHQ-9).
- Participant taking antidepressants or engaged in psychotherapy will not be excluded. If potential participants are currently prescribed psychotropic medication, they must be on a clinically stable medication regimen for ≥ 6 weeks prior to screening, based on self-report or as verified by medical health records, when available and authorized.
- Participant must be a fluent English speaker.
- Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control and use a mobile device and/or computer as required to complete study activities.
Key exclusion criteria (8 listed)
- Participant with unstable and/or untreated conditions that may affect cognition, including untreated substance abuse/dependence disorders, unmanaged cardiovascular disease, endocrine or neurologic disorder, epilepsy, brain injury, hospitalization within 6-weeks of enrollment, ongoing chemotherapy or other cancer treatment (e.g., radiation) .
- Participant with history or current DSM-5 diagnosis of psychosis, such as schizophrenia, schizoaffective disorder, delusion disorder, psychotic disorder NOS, bipolar disorder, substance abuse (<1 year), and/or mood congruent or mood incongruent psychotic features or disorders.
- Participant has a history or current diagnosis of dementia and/or scores less than a 14 (75%) on the UBACC.
- Participant with active suicidal ideations or behaviors within 2 months of screening.
- Participant that shows signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit. Such participants will have that visit re-scheduled; participants with this problem occurring more than once may be excluded and dropped at the discretion of the Principal Investigators.
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 |
|---|---|---|
| Mobile-device, plasticity-based adaptive cognitive treatmentAlso: MMTThis study employs a mobile-device delivered treatment program. Participants will be asked to use the assigned treatment program for approximately 30 minutes per session, up to seven sessions per week, over 6 weeks (42 total sessions). | Other | MMT |
Primary outcome
Change in total score for depressive symptoms using Beck Depression Scale (BDI-II)
Time frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
The Beck Depression Scale (BDI-II) is a self-report questionnaire that assesses depressive symptoms with a scoring range between 0-63.
4 secondary outcomes
Change in total score for depressive symptoms using Patient Health Questionnaire (PHQ-9)
Time frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Change in total score for anxiety symptoms using Generalized Anxiety Disorder (GAD-7)
Time frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Change in total score for mood symptoms using Immediate Mood Scaler (IMS)
Time frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Change in total score for quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time frame: At 2 weeks, 4 weeks, 6 weeks and at 12 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 5 Jun 2023.
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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.
Gamze Balci, MD principal investigator
University of Minnesota - Department of Psychiatry
Thomas Van Vleet, PhD principal investigator
Posit Science Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile-device, plasticity-based adaptive cognitive treatment in people with Major Depressive Disorder, run by Posit Science Corporation 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 7 inclusion and 8 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 5 Jun 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 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?
Change in total score for depressive symptoms using Beck Depression Scale (BDI-II) (time frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks). 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 5 Jun 2023.