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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01MH136025 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness with tailored messages | Active Comparator | Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker. |
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| Mindfulness without tailored messages | Active Comparator | Participants will receive an app-based intervention and standard feedback from activity tracker. |
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| Cognitive Behavioral Therapy (CBT) with tailored messages | Active Comparator | Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker. |
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| Cognitive Behavioral Therapy (CBT) without tailored messages | Active Comparator | Participants will receive an app-based intervention and standard feedback from activity tracker. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness + Tailored Messages | Behavioral | Tailored Messages (TM) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Messages will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual messages. The study will use an app designed to train the user in mindfulness practices. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression as measured by the Patient Health Questionnaire 9(PHQ-9) | The PHQ-9 is an instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 incorporates self-report questions on 9 specific depression symptoms that align with the DSM-IV depression diagnostic criteria. PHQ-9 scores range from 0-27 and 27 indicates severe depression. | From enrollment to the 6-week assessment. |
| Anxiety as measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | GAD-7 consists total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety, respectively. | From enrollment to the 6-week assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Shared within National Institute of Mental Health Data Archive via grant data collaborator core.
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|
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| Mindfulness without Tailored Messages | Behavioral | The study will use an app designed to train the user in mindfulness practices. |
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| Cognitive Behavioral Therapy (CBT) + Tailored Messages | Behavioral | Tailored Messages (TM) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Messages will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual messages. The study will use an app designed to deliver cognitive behavioral therapy. |
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| Cognitive Behavioral Therapy (CBT) without Tailored Messages | Behavioral | The study will use an app designed to deliver cognitive behavioral therapy. |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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