Back to resultsUsing a Smartphone App to Target Current Mental Health Symptoms of Anxiety and Depression
Primary Purpose
Depression, Anxiety, Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mood Triggers App
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Cancer Prevention, Passive sensing
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MoodTriggers App
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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.
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
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
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
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
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.
Secondary Outcome Measures
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.
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.
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).
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.
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.
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.
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.
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).
Full Information
NCT ID
NCT06037382
First Posted
July 31, 2023
Last Updated
September 7, 2023
Sponsor
Trustees of Dartmouth College
Collaborators
Norris Cotton Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT06037382
Brief Title
Using a Smartphone App to Target Current Mental Health Symptoms of Anxiety and Depression
Official Title
Using a Smartphone App to Target Current Mental Health Symptoms of Anxiety and Depression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 21, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trustees of Dartmouth College
Collaborators
Norris Cotton Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Cancer
Keywords
Cancer Prevention, Passive sensing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MoodTriggers App
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mood Triggers App
Intervention Description
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 Outcome Measure Information:
Title
Changes in depression as assessed by Patient Health Questionnaire-9
Description
Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity
Time Frame
Baseline
Title
Changes in depression as assessed by Patient Health Questionnaire-9
Description
Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity.
Time Frame
6 weeks post-baseline
Title
Changes in depression as assessed by Patient Health Questionnaire-9
Description
Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity
Time Frame
12 weeks post-baseline
Title
Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale
Description
Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity
Time Frame
At baseline
Title
Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale
Description
Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity
Time Frame
6 weeks post-baseline
Title
Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale
Description
Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity
Time Frame
12 weeks post-baseline
Title
World Cancer Research Fund (WCRF)/ American Institute for Cancer Research (AICR) Cancer Prevention Score.
Description
Minimum score: 0, Maximum score: 7-8 (8 for persons capable of breastfeeding). Greater scores suggest lower cancer risk.
Time Frame
Up to 12 weeks after enrollment
Secondary Outcome Measure Information:
Title
Smartphone estimates of sociability as mechanisms of change in cancer risk
Description
Based on continuous passive mobile sensor data, sociability estimates will be based on the frequency of phone calls and texts.
Time Frame
Up to 12 weeks after enrollment
Title
Smartphone estimates of motion activity as mechanisms of change in cancer risk
Description
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.
Time Frame
Up to 12 weeks after enrollment
Title
Diet as mechanism of change in cancer risk
Description
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).
Time Frame
Baseline, 6 weeks post-baseline, 12 weeks post-baseline
Title
Momentary Assessment of Anxiety Symptom Changes
Description
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.
Time Frame
Up to 12 weeks after enrollment
Title
Momentary Assessment of Depression Symptom Changes
Description
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.
Time Frame
Up to 12 weeks after enrollment
Title
Momentary Assessment of Behavioral Avoidance Symptom Changes
Description
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.
Time Frame
Up to 12 weeks after enrollment
Title
Momentary Assessment of Hopelessness Symptom Changes
Description
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.
Time Frame
Up to 12 weeks after enrollment
Title
Momentary Assessment of Arousal Symptom Changes
Description
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).
Time Frame
Up to 12 weeks after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eilis I Murphy, BA
Phone
6036467000
Email
Eilis.I.Murphy@dartmouth.edu
12. IPD Sharing Statement
Learn more about this trial
Using a Smartphone App to Target Current Mental Health Symptoms of Anxiety and Depression
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