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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Cancer; Anxiety
• Intervention / Treatment: Other: Mood Triggers App

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Hanover, New Hampshire, United States, 03755
      • Dartmouth College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MoodTriggers 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.

Other: Mood 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Trustees of Dartmouth College
• Collaborators: Norris Cotton Cancer Center
• Investigators: Principal Investigator: Nicholas C Jacobson, PhD, Geisel School of Medicine, Dartmouth College

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Actual): March 6, 2025
• Study Completion (Actual): March 6, 2025

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Cancer Prevention; Passive sensing
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Anxiety Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: STUDY00032649

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No