DepressionNCT03633682
Evaluation of Text Message Engagement Support of Mindfulness Smartphone Applications
A study testing Headspace - Meditation and Mindfulness App and Stop, Breathe, & Think - Meditation and Mindfulness App in people with Depression and Anxiety, run by Northwestern University at 1 site in United States.
Trial summary
The aim of this study is to assess the usability of two mindfulness smartphone applications (apps) and to evaluate whether text message support can promote engagement with those apps through a 4-week trial comparing support vs. no support. 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?
- Headspace - Meditation and Mindfulness App and Stop, Breathe, & Think - Meditation and Mindfulness App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2018to 1 Aug 2020
- 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
- meet criteria for clinically significant distress caused by anxiety defined by a Generalized Anxiety Disorder-7 (GAD-7) greater than a 10 or clinically significant distress caused my depression defined by a Patient Health Questionnaire (PHQ-9) greater than 10
- 18 years of age or older;
- fluent in English;
- lives in the Chicago area and are able to attend and in person session;
- own an internet ready smartphone with data and text plans.
Who cannot join
- have visual, hearing, voice, or motor impairment that would prevent completion treatment procedures;
- past or current diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, substance or alcohol abuse dependence, or other diagnosis for which participation in the trial would be dangerous;
- suicidal, defined as a 1 or higher on item 9 of the Patient Health Questionnaire (PHQ-9);
- adults unable to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwester University, Feinberg School of Medicine, Center for Behavioral Intervention Technologies
Chicago, Illinois, 60611
About this study
Official title: Evaluation of Text Message Engagement Support of Mindfulness Smartphone
The aim of this study is to assess the usability of two mindfulness smartphone applications (apps) and to evaluate whether text message support can promote engagement with those apps through a 4-week trial comparing support vs. no support.
Read the detailed description
Part one of this study is to conduct usability testing to understand more about the acceptability and usability of these existing mindfulness apps in a population with depression and anxiety. The goal of usability testing is to identify any usability problems, provide information for future app development, and determine the participant's satisfaction with the apps. Participants will then be randomized to receive either engagement support or no support which will be delivered via text messaging, and will be randomized to use one of the two mindfulness applications for the 4 week period. Specific Aim 2.1 is to evaluate any differences on outcome measures between the two mindfulness apps. Specific Aim 2.2 is to evaluate the differences of outcome measures between text message engagement support versus no support, regardless of the mindfulness app. For Aim 2.1, the investigators predict that all mindfulness apps will be capable of leading to improvements on outcome measures. For Aim 2.2, the investigators predict that the text message engagement support arm will engage more with the mindfulness app and will see greater improvements in outcome measures regardless of the mindfulness app.
- Conditions
- Depression, Anxiety
- Being tested
- Headspace - Meditation and Mindfulness App, Stop, Breathe, & Think - Meditation and Mindfulness App
- 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.
Headspace - Meditation and Mindfulness AppBehavioural
Participants randomized to this arm will receive 1-month full access to the Headspace meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep.
Stop, Breathe, & Think - Meditation and Mindfulness AppBehavioural
Participants randomized to this arm will receive 1-month full access to the Stop, Breathe, \& Think meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep.
| Study group | Role | What they receive |
|---|---|---|
| Engagement Support | Experimental | In the engagement support group, participants will be sent text messages that will encourage use of the app through tips, reminders, and encouraging messages. Receives: Behavioral: Headspace - Meditation and Mindfulness App; Behavioral: Stop, Breathe, & Think - Meditation and Mindfulness App |
| No Engagement Support | Other | Participants in this group will receive no text message support. Receives: Behavioral: Headspace - Meditation and Mindfulness App; Behavioral: Stop, Breathe, & Think - Meditation and Mindfulness App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression and Anxiety at Week 2 and Week 4
Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depression. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day).
Measured: Baseline, Week 2, Week 4
Change in Anxiety at Week 2 and Week 4
Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 is a 7-item self-report measure of anxiety. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day).
Measured: Baseline, Week 2, Week 4
Secondary outcomes (2)
App Usage
App usage will be defined as how many minutes the participant meditated and how many meditations they listened to.
Measured: Week 1, Week 2, Week 3, Week 4
App Satisfaction
App satisfaction evaluates the participants satisfaction with the app on a scale ranging from 1 (Not At All) to 5 (Extremely).
Measured: Week 1, Week 2, Week 3, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start26 Jun 2018
- Primary completion1 Jul 2020
- Study completion1 Aug 2020
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Schueller, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633682
- Sponsor's protocol ID
- STU00206204
- Status last verified
- Jul 2021
- First submitted
- 26 Jun 2018
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Text Message Engagement Support of Mindfulness Smartphone
- ClinicalTrials.gov ID
- NCT03633682
- Acronym / sponsor ID
- STU00206204
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 16 Aug 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 aim of this study is to assess the usability of two mindfulness smartphone applications (apps) and to evaluate whether text message support can promote engagement with those apps through a 4-week trial comparing support vs. no support.
Detailed description
Part one of this study is to conduct usability testing to understand more about the acceptability and usability of these existing mindfulness apps in a population with depression and anxiety. The goal of usability testing is to identify any usability problems, provide information for future app development, and determine the participant's satisfaction with the apps. Participants will then be randomized to receive either engagement support or no support which will be delivered via text messaging, and will be randomized to use one of the two mindfulness applications for the 4 week period. Specific Aim 2.1 is to evaluate any differences on outcome measures between the two mindfulness apps. Specific Aim 2.2 is to evaluate the differences of outcome measures between text message engagement support versus no support, regardless of the mindfulness app. For Aim 2.1, the investigators predict that all mindfulness apps will be capable of leading to improvements on outcome measures. For Aim 2.2, the investigators predict that the text message engagement support arm will engage more with the mindfulness app and will see greater improvements in outcome measures regardless of the mindfulness app.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Engagement Support | Experimental | Behavioral: Headspace - Meditation and Mindfulness App, Behavioral: Stop, Breathe, & Think - Meditation and Mindfulness AppIn the engagement support group, participants will be sent text messages that will encourage use of the app through tips, reminders, and encouraging messages. |
| No Engagement Support | Other | Behavioral: Headspace - Meditation and Mindfulness App, Behavioral: Stop, Breathe, & Think - Meditation and Mindfulness AppParticipants in this group will receive no text message support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- meet criteria for clinically significant distress caused by anxiety defined by a Generalized Anxiety Disorder-7 (GAD-7) greater than a 10 or clinically significant distress caused my depression defined by a Patient Health Questionnaire (PHQ-9) greater than 10
- 18 years of age or older;
- fluent in English;
- lives in the Chicago area and are able to attend and in person session;
- own an internet ready smartphone with data and text plans.
Key exclusion criteria (4 listed)
- have visual, hearing, voice, or motor impairment that would prevent completion treatment procedures;
- past or current diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, substance or alcohol abuse dependence, or other diagnosis for which participation in the trial would be dangerous;
- suicidal, defined as a 1 or higher on item 9 of the Patient Health Questionnaire (PHQ-9);
- adults unable to consent.
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 |
|---|---|---|
| Headspace - Meditation and Mindfulness AppParticipants randomized to this arm will receive 1-month full access to the Headspace meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep. | Behavioural | Engagement Support, No Engagement Support |
| Stop, Breathe, & Think - Meditation and Mindfulness AppParticipants randomized to this arm will receive 1-month full access to the Stop, Breathe, \& Think meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep. | Behavioural | Engagement Support, No Engagement Support |
Primary outcome
Change in Depression and Anxiety at Week 2 and Week 4
Time frame: Baseline, Week 2, Week 4
Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depression. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day).
Change in Anxiety at Week 2 and Week 4
Time frame: Baseline, Week 2, Week 4
Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 is a 7-item self-report measure of anxiety. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day).
2 secondary outcomes
App Usage
Time frame: Week 1, Week 2, Week 3, Week 4
App Satisfaction
Time frame: Week 1, Week 2, Week 3, Week 4
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 2 Jul 2021.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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 Headspace - Meditation and Mindfulness App and Stop, Breathe, & Think - Meditation and Mindfulness App in people with Depression and Anxiety, 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 4 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 2 Jul 2021. 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 Depression and Anxiety at Week 2 and Week 4 (time frame: Baseline, Week 2, Week 4). 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 2 Jul 2021.