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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037382
• Other study ID #: STUDY00032649
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2023
• Source: Trustees of Dartmouth College
• Contact: Eilis I Murphy, BA
• Phone: 6036467000
• Email: Eilis.I.Murphy[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cancer
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth College	Hanover	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Trustees of Dartmouth College	Norris Cotton Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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