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

Not Applicable

Completed

• Conditions: Anxiety; Depression; Cancer
• Interventions: Other: Mood Triggers App

• Registration Number: NCT06037382
• Lead Sponsor: Trustees of Dartmouth College

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.

Study Timeline

• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Study Start: 2023-09-25
• Status Verified: 2025-03
• Primary Completion: 2025-03-06
• Study Completion: 2025-03-06
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MoodTriggers App	Mood Triggers App	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.

Primary Outcome Measures

Name	Time	Method
Changes in depression as assessed by Patient Health Questionnaire-9	12 weeks post-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	12 weeks post-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 Outcome Measures

Name	Time	Method
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 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 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.
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).
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 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.
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.
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.

Trial Locations

Locations (1)

Dartmouth College; 🇺🇸 Hanover, New Hampshire, United States