DepressionNCT03121937
Feasibility of a Technology-Based Treatment Support System
A study testing Mobile App in people with Depression and Depressive Disorder, Major, run by Northwestern University at 1 site in United States.
Trial summary
This study aims to evaluate a technology-based treatment support system for patients undergoing the treatment of depression. The investigators will explore the usefulness of the technology-based treatment support system as an adjunct to psychotherapy for depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Depressive Disorder, Major
- What is being tested?
- Mobile App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 30 Jun 2018
- 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
- 18 years of age or older
- English-speaking
- Currently enrolled in outpatient treatment
- Current diagnosis of major depressive disorder
- Ownership of a smartphone device compatible with the mobile app
Who cannot join
- visual, hearing, voice, or motor impairment that would prevent completion of the study procedures or use of mobile phone
- diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder, or other diagnosis for which participation in this trial is inappropriate, severe suicidality (has ideation, plan, and intent).
- having completed more than 3 sessions of psychotherapy with current therapist
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate a technology-based treatment support system for patients undergoing the treatment of depression. The investigators will explore the usefulness of the technology-based treatment support system as an adjunct to psychotherapy for depression.
Read the detailed description
This study aims to evaluate a technology-based treatment support system "mConnect" for patients undergoing the treatment of depression. This system will be evaluated by conducting a randomized controlled trial where patients will either receive the mConnect mobile app or treatment as usual.
- Conditions
- Depression, Depressive Disorder, Major
- Being tested
- Mobile App
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile AppBehavioural
The mobile app "mConnect" is an app designed to facilitate psychotherapy for depression and includes mood tracking, goal setting, and communication
| Study group | Role | What they receive |
|---|---|---|
| Mobile App | Experimental | Participants will receive a mobile app to be used during psychotherapy that syncs information with the participant's therapist from sessions. Receives: Behavioral: Mobile App |
| Treatment as Usual | No intervention | Participants will receive treatment as usual with aspects of the mobile app available through paper-based worksheets. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Number of completed sessions
Measured: 8 weeks
Adherence
The use of the mobile app. This data will be collected passively by the mobile app sending the following information to the secure server: the date and time the mobile app is launched, the date and time any information is entered into the mobile app, the content of any information entered into the mobile app, the date and time any lessons within the mobile app are read by the participant.
Measured: 8 weeks
Satisfaction
Participant satisfaction with the mobile app will be assessed with a patient version of the Mobile App Rating Scale (MARS) that addresses engagement, functionality, aesthestics, information quality, and one subjective rating of the app as a whole.
Measured: 8 weeks
Secondary outcomes (1)
Depression
Depression as measured by the PHQ-9
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 posted20 Apr 2017
- Study start1 Aug 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Why it stopped: No longer able to recruit participants
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 Northwestern UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Stephen Schueller, Northwestern University
- Investigators
- Stephen M Schueller, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121937
- Sponsor's protocol ID
- STU00097492
- Other IDs
- K08MH102336
- Status last verified
- Apr 2017
- First submitted
- 11 Apr 2017
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Technology-Based Treatment Support System
- ClinicalTrials.gov ID
- NCT03121937
- Acronym / sponsor ID
- STU00097492
- Conditions
- Depression, Depressive Disorder, Major
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer able to recruit participants
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 20 Apr 2017 (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.
This study aims to evaluate a technology-based treatment support system for patients undergoing the treatment of depression. The investigators will explore the usefulness of the technology-based treatment support system as an adjunct to psychotherapy for depression.
Detailed description
This study aims to evaluate a technology-based treatment support system "mConnect" for patients undergoing the treatment of depression. This system will be evaluated by conducting a randomized controlled trial where patients will either receive the mConnect mobile app or treatment as usual.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile App | Experimental | Behavioral: Mobile AppParticipants will receive a mobile app to be used during psychotherapy that syncs information with the participant's therapist from sessions. |
| Treatment as Usual | No intervention | –Participants will receive treatment as usual with aspects of the mobile app available through paper-based worksheets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- English-speaking
- Currently enrolled in outpatient treatment
- Current diagnosis of major depressive disorder
- Ownership of a smartphone device compatible with the mobile app
Key exclusion criteria (3 listed)
- visual, hearing, voice, or motor impairment that would prevent completion of the study procedures or use of mobile phone
- diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder, or other diagnosis for which participation in this trial is inappropriate, severe suicidality (has ideation, plan, and intent).
- having completed more than 3 sessions of psychotherapy with current therapist
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 AppThe mobile app "mConnect" is an app designed to facilitate psychotherapy for depression and includes mood tracking, goal setting, and communication | Behavioural | Mobile App |
Primary outcome
Retention
Time frame: 8 weeks
Number of completed sessions
Adherence
Time frame: 8 weeks
The use of the mobile app. This data will be collected passively by the mobile app sending the following information to the secure server: the date and time the mobile app is launched, the date and time any information is entered into the mobile app, the content of any information entered into the mobile app, the date and time any lessons within the mobile app are read by the participant.
Satisfaction
Time frame: 8 weeks
Participant satisfaction with the mobile app will be assessed with a patient version of the Mobile App Rating Scale (MARS) that addresses engagement, functionality, aesthestics, information quality, and one subjective rating of the app as a whole.
1 secondary outcome
Depression
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: No longer able to recruit participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- 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.
Stephen M Schueller, PhD principal investigator
Northwestern University
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 App in people with Depression and Depressive Disorder, Major, run by Northwestern University 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 10 Oct 2018. 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 stopped early (reason given: No longer able to recruit participants). Results are not available in the source record.
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?
Retention (time frame: 8 weeks). The study lists 3 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 10 Oct 2018.