DepressionNCT01107041
Mobile Phone Sensing and Outreach as Adjuncts to Internet-Based Behavioral Intervention for Depression
A study testing Mobilyze! in people with Depression, run by Northwestern University at 1 site in United States.
Trial summary
Investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Mobilyze!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,010 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jul 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PHQ-9 score 10 or higher
- Has an e-mail account, computer, and broadband access to the Internet
- Familiarity with mobile phones and is within a cellular network range the majority of the day.
- Is able to speak and read English.
- Is at least 19 years of age.
Who cannot join
- Hearing or voice impairment preventing participation in psychotherapy.
- Visual impairment that would prevent use of the website, mobile phone application, and assessment materials.
- Has any psychiatric condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous (e.g., psychotic disorders, bipolar disorders, dissociative disorders, etc.).
- Planning to be out of town or unavailable for intervention for 1 or more weeks during the scheduled study participation.
- Exhibits severe suicidality, including ideation, plan, and intent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technology Assisted Intervention for the Treatment and Prevention of Depression
Investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety.
Read the detailed description
Investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety. Participants will include people who are high on depression, high on anxiety, hight on both depression and anxiety, and health controls. Particpants will load software on their phones that collects phone sensor data, and obtains self report on sleep, mood, and social contacts. Data will be collected for at least 6 weeks.
- Conditions
- Depression
- Being tested
- Mobilyze!
- Keywords
- Depression, Technology Assisted, Mobile Phone
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilyze!Behavioural
Mobilyze! delivers behavioral intervention for depression via a mobile phone, interactive website, and e-mail.
| Study group | Role | What they receive |
|---|---|---|
| Mobilyze! | Experimental | Not described Receives: Behavioral: Mobilyze! |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, as assessed the Patient Health Questionnaire-9
Measured: Baseline, Weeks 2-6
Secondary outcomes (2)
Positive Affect (PANAS - Positive Affect Scale)
Measured: Baseline, Weeks 2-6
Anxiety (GAD-7)
Measured: Baseline, Weeks 2-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startDec 2014
- Primary completionFeb 2016
- Study completionJul 2016
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is collecting phone sensor data and ecological momentary assessment data to try to develop algorithms that can passively detect behavioral patterns in participants
- Masking
- None (open label)
- Enrolment
- 2,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Mohr, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107041
- Sponsor's protocol ID
- P20MH090318 STU00021825
- Other IDs
- P20MH090318
- Status last verified
- Oct 2015
- First submitted
- 19 Apr 2010
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Burns MN, Begale M, Duffecy J, Gergle D, Karr CJ, Giangrande E, Mohr DC. Harnessing context sensing to develop a mobile intervention for depression. J Med Internet Res. 2011 Aug 12;13(3):e55. doi: 10.2196/jmir.1838.
PubMed 21840837
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Assisted Intervention for the Treatment and Prevention of Depression
- ClinicalTrials.gov ID
- NCT01107041
- Acronym / sponsor ID
- P20MH090318 STU00021825
- Conditions
- Depression
- Keywords
- Depression, Technology Assisted, Mobile Phone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,010 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Apr 2010 (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.
Investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety.
Detailed description
Investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety. Participants will include people who are high on depression, high on anxiety, hight on both depression and anxiety, and health controls. Particpants will load software on their phones that collects phone sensor data, and obtains self report on sleep, mood, and social contacts. Data will be collected for at least 6 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is collecting phone sensor data and ecological momentary assessment data to try to develop algorithms that can passively detect behavioral patterns in participants
| Arm | Type | Receives |
|---|---|---|
| Mobilyze! | Experimental | Behavioral: Mobilyze! |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PHQ-9 score 10 or higher
- Has an e-mail account, computer, and broadband access to the Internet
- Familiarity with mobile phones and is within a cellular network range the majority of the day.
- Is able to speak and read English.
- Is at least 19 years of age.
Key exclusion criteria (5 listed)
- Hearing or voice impairment preventing participation in psychotherapy.
- Visual impairment that would prevent use of the website, mobile phone application, and assessment materials.
- Has any psychiatric condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous (e.g., psychotic disorders, bipolar disorders, dissociative disorders, etc.).
- Planning to be out of town or unavailable for intervention for 1 or more weeks during the scheduled study participation.
- Exhibits severe suicidality, including ideation, plan, and intent.
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 |
|---|---|---|
| Mobilyze!Mobilyze! delivers behavioral intervention for depression via a mobile phone, interactive website, and e-mail. | Behavioural | Mobilyze! |
Primary outcome
Depression, as assessed the Patient Health Questionnaire-9
Time frame: Baseline, Weeks 2-6
2 secondary outcomes
Positive Affect (PANAS - Positive Affect Scale)
Time frame: Baseline, Weeks 2-6
Anxiety (GAD-7)
Time frame: Baseline, Weeks 2-6
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 24 Mar 2017.
- Derived from this study: PubMed 21840837Burns MN, Begale M, Duffecy J, Gergle D, Karr CJ, Giangrande E, Mohr DC. Harnessing context sensing to develop a mobile intervention for depression. J Med Internet Res. 2011 Aug 12;13(3):e55. doi: 10.2196/jmir.1838.
- MedlinePlusLink provided by the sponsor.
- Depression at MedlinePlus SiteLink provided by the sponsor.
- Mental Health at MedlinePlus SiteLink provided by the sponsor.
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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 Mobilyze! in people with Depression, 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 5 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 24 Mar 2017. 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?
Depression, as assessed the Patient Health Questionnaire-9 (time frame: Baseline, Weeks 2-6). 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 NCT01107041, 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 24 Mar 2017.