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Completed

NCT Number: NCT06037382

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cancer Mental Disorders Neoplasms

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth College

Hanover, New Hampshire, 03755, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Changes in depression as assessed by Patient Health Questionnaire-9

    Time frame: Baseline

    Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity

  2. Changes in depression as assessed by Patient Health Questionnaire-9

    Time frame: 6 weeks post-baseline

    Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity.

  3. Changes in depression as assessed by Patient Health Questionnaire-9

    Time frame: 12 weeks post-baseline

    Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity

  4. Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale

    Time frame: At baseline

    Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity

  5. Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale

    Time frame: 6 weeks post-baseline

    Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity

  6. Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale

    Time frame: 12 weeks post-baseline

    Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity

  7. World Cancer Research Fund (WCRF)/ American Institute for Cancer Research (AICR) Cancer Prevention Score.

    Time frame: 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 outcomes

  1. Smartphone estimates of sociability as mechanisms of change in cancer risk

    Time frame: 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.

  2. Smartphone estimates of motion activity as mechanisms of change in cancer risk

    Time frame: 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.

  3. Diet as mechanism of change in cancer risk

    Time frame: 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).

  4. Momentary Assessment of Anxiety Symptom Changes

    Time frame: 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.

  5. Momentary Assessment of Depression Symptom Changes

    Time frame: 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.

  6. Momentary Assessment of Behavioral Avoidance Symptom Changes

    Time frame: 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.

  7. Momentary Assessment of Hopelessness Symptom Changes

    Time frame: 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.

  8. Momentary Assessment of Arousal Symptom Changes

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Trustees of Dartmouth College

Other

Collaborators

  • Norris Cotton Cancer Center

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 14, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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