Using a Smartphone App to Target Current Mental Health Symptoms of Anxiety and Depression

Study Overview
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Brief Summary
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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.

Official Title
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Using a Smartphone App to Target Current Mental Health Symptoms of Anxiety and Depression

Conditions
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Depression, Anxiety, Cancer

Intervention / Treatment
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* Other: Mood Triggers App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Middle-aged adults (age 40 to 64). fluent in English. Able to provide informed consent. Meets current criteria for an anxiety and/or depressive disorder with severity ranging from moderate to severe (based on the Patient Health Questionnaire - 9 and the Generalized Anxiety Disorder Questionnaire). Owns a smartphone. Exclusion Criteria: Acute psychosis (based on the self-reported Structured Interview for Psychosis risk Syndromes, Prodromal Questionnaire - Brief version [SIPS PQ-B]). Moderate to high suicidal ideation (based on a response of 2 or more on the PHQ-9 item-9). History of bipolar disorder (based on the self-reported Mood Disorder Questionnaire [MDQ]. Past or current diagnoses of cancer. Changes to treatments or medications in the past 30 days.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MoodTriggers App<br>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. | Other: Mood Triggers App<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Prevention, Passive sensing