Anxiety, Cancer, Depression
Conditions
Keywords
Cancer Prevention, Passive sensing
Brief summary
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.
Detailed description
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.
Interventions
OTHERMood Triggers App
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.
Sponsors
Norris Cotton Cancer Center
Trustees of Dartmouth College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Middle-aged adults (age 40 to 64). 2. fluent in English. 3. Able to provide informed consent. 4. 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). 5. Owns a smartphone.
Exclusion criteria
1. Acute psychosis (based on the self-reported Structured Interview for Psychosis risk Syndromes, Prodromal Questionnaire - Brief version \[SIPS PQ-B\]). 2. Moderate to high suicidal ideation (based on a response of 2 or more on the PHQ-9 item-9). 3. History of bipolar disorder (based on the self-reported Mood Disorder Questionnaire \[MDQ\]. 4. Past or current diagnoses of cancer. 5. Changes to treatments or medications in the past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in depression as assessed by Patient Health Questionnaire-9 | Baseline | Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity |
| Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale | At baseline | Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity |
| World Cancer Research Fund (WCRF)/ American Institute for Cancer Research (AICR) Cancer Prevention Score. | Up to 12 weeks after enrollment | Minimum score: 0, Maximum score: 7-8 (8 for persons capable of breastfeeding). Greater scores suggest lower cancer risk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Momentary Assessment of Anxiety Symptom Changes | Up to 12 weeks after enrollment | 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. |
| Momentary Assessment of Depression Symptom Changes | Up to 12 weeks after enrollment | 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. |
| Smartphone estimates of sociability as mechanisms of change in cancer risk | Up to 12 weeks after enrollment | Based on continuous passive mobile sensor data, sociability estimates will be based on the frequency of phone calls and texts. |
| Momentary Assessment of Hopelessness Symptom Changes | Up to 12 weeks after enrollment | 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. |
| Momentary Assessment of Arousal Symptom Changes | Up to 12 weeks after enrollment | 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). |
| Momentary Assessment of Behavioral Avoidance Symptom Changes | Up to 12 weeks after enrollment | 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. |
| Smartphone estimates of motion activity as mechanisms of change in 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. |
| Diet as mechanism of change in cancer risk | Baseline, 6 weeks post-baseline, 12 weeks post-baseline | 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). |
Countries
United States
Outcome results
None listed