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| Name | Class |
|---|---|
| Norris Cotton Cancer Center | OTHER |
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This is a prevention intervention study that will examine the efficacy of a smartphone-based intervention in decreasing cancer risk by targeting mental health risk factors of anxiety and depression.
This prevention intervention study aims to examine the efficacy of a smartphone-based intervention in decreasing cancer risk by targeting mental health risk factors of anxiety and depression. The study will utilize a smartphone application called Mood Triggers, designed to provide personalized feedback on individuals' maintenance factors (i.e., "triggers") of their anxiety and depressive symptoms. Mood Triggers delivers ultra-brief interventions (less than 2 minutes long) where participants view videos introducing important skills to treat their anxiety and depression. The study targets middle-aged adults (40-64 years old) who meet current criteria for moderate to severe anxiety and/or depressive disorders. It will enroll an anticipated 100 participants in a single-group, open-label design, with the intervention lasting up to 12 weeks. The primary outcomes include changes in depression and anxiety symptoms, measured by the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-Q-IV Scale, respectively, as well as changes in cancer risk assessed by the World Cancer Research Fund/American Institute for Cancer Research Cancer Prevention Score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MoodTriggers App | Experimental | Mood Triggers provides personalized feedback on individuals' maintenance factors (i.e., "triggers") of their anxiety and depressive symptoms based on the theory that such feedback will lead to symptom reduction. Mood Triggers delivers ultra-brief interventions (less than 2 minutes long) where participants view videos which introduce an important skill to treat their anxiety and depressive. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mood Triggers App | Other | The current intervention will deploy a smartphone application called Mood Triggers. Mood Triggers was designed to provide personalized feedback on individuals' maintenance factors (i.e., "triggers") of their anxiety and depressive symptoms based on the theory that such feedback will lead to symptom reduction. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in depression as assessed by Patient Health Questionnaire-9 | Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity | Baseline |
| Changes in depression as assessed by Patient Health Questionnaire-9 | Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity. | 6 weeks post-baseline |
| Changes in depression as assessed by Patient Health Questionnaire-9 | Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity | 12 weeks post-baseline |
| Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale | Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity | At baseline |
| Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale | Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity | 6 weeks post-baseline |
| Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale | Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity | 12 weeks post-baseline |
| World Cancer Research Fund (WCRF)/ American Institute for Cancer Research (AICR) Cancer Prevention Score. |
| Measure | Description | Time Frame |
|---|---|---|
| Smartphone estimates of sociability as mechanisms of change in cancer risk | Based on continuous passive mobile sensor data, sociability estimates will be based on the frequency of phone calls and texts. | Up to 12 weeks after enrollment |
| Smartphone estimates of motion activity as mechanisms of change in cancer risk |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas C Jacobson, PhD | Geisel School of Medicine, Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth College | Hanover | New Hampshire | 03755 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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Minimum score: 0, Maximum score: 7-8 (8 for persons capable of breastfeeding). Greater scores suggest lower cancer risk. |
| Up to 12 weeks after enrollment |
Based on both activity levels based on the metabolic equivalent of task (MET) based on passively observed accelerometer data from the smartphone and daily movement based on geolocation data passively collected from the smartphone. |
| Up to 12 weeks after enrollment |
| Diet as mechanism of change in cancer risk | Self-reported dietary intake will be recorded via entry of food intake in ASA24 and used when calculating WCRF/AICR cancer score. Diets rich in nutrients contribute to higher score (lower risk). | Baseline, 6 weeks post-baseline, 12 weeks post-baseline |
| Momentary Assessment of Anxiety Symptom Changes | Thirteen items from a modified PHQ/GAD questionnaire will be used to measure daily anxiety and depression. Participants will rate answers on a 101 point scale ranging from 0-100 and is scaled from "Not at all" - "Constantly". Higher scores indicate generally more severe anxiety symptoms. | Up to 12 weeks after enrollment |
| Momentary Assessment of Depression Symptom Changes | Thirteen items from a modified PHQ/GAD questionnaire will be used to measure daily anxiety and depression. Participants will rate answers on a 101 point scale ranging from 0-100 and is scaled from "Not at all" - "Constantly". Higher scores indicate generally more severe MDD symptoms. | Up to 12 weeks after enrollment |
| Momentary Assessment of Behavioral Avoidance Symptom Changes | One item adapted from the Multidimensional Experiential Avoidance Questionnaire will be presented to measure daily changes in behavioral avoidance. A second item will be asked to measure self-reported changes in behavioral avoidance since the previous prompt. | Up to 12 weeks after enrollment |
| Momentary Assessment of Hopelessness Symptom Changes | One item adapted from the Hopelessness Scale will be presented to gather a momentary measurement. A second momentary measurement will be presented to gather current self-report of feeling hopelessness. | Up to 12 weeks after enrollment |
| Momentary Assessment of Arousal Symptom Changes | A self-report measure will ask current level of arousal on a sliding scale from "Sleepy" to "Active". Minimum or maximum values range from 0 (Sleepy) to 1 (Active). | Up to 12 weeks after enrollment |