DepressionNCT06037382
Using a Smartphone App to Target Current Mental Health Symptoms of Anxiety and Depression
A study testing Mood Triggers App in people with Depression and Anxiety, run by Trustees of Dartmouth College at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Depression, Anxiety, Cancer
- What is being tested?
- Mood Triggers App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2023to 6 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Depression, Anxiety, Cancer
- Being tested
- Mood Triggers App
- Keywords
- Cancer Prevention, Passive sensing
- Medical subject headings
- Depression, Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mood Triggers AppOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MoodTriggers App | Experimental | 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. Receives: Other: Mood Triggers App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 12 weeks after enrollment
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Up to 12 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start25 Sep 2023
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trustees of Dartmouth College
- Sponsor type
- University, hospital or other
- Collaborators
- Norris Cotton Cancer Center
- Responsible party
- Principal investigator, Nicholas Jacobson, Trustees of Dartmouth College
- Investigators
- Nicholas C Jacobson, PhD, Principal investigator, Geisel School of Medicine, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037382
- Sponsor's protocol ID
- STUDY00032649
- Status last verified
- Mar 2025
- First submitted
- 31 Jul 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Smartphone App to Target Current Mental Health Symptoms of Anxiety and Depression
- ClinicalTrials.gov ID
- NCT06037382
- Acronym / sponsor ID
- STUDY00032649
- Conditions
- Depression, Anxiety, Cancer
- Keywords
- Cancer Prevention, Passive sensing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Trustees of Dartmouth CollegeUniversity, hospital or other
- Collaborators
- Norris Cotton Cancer Center
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MoodTriggers App | Experimental | Other: Mood Triggers AppMood 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. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mood Triggers AppThe 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. | Other | MoodTriggers App |
Primary outcome
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
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.
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
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
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
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
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.
8 secondary outcomes
Smartphone estimates of sociability as mechanisms of change in cancer risk
Time frame: Up to 12 weeks after enrollment
Smartphone estimates of motion activity as mechanisms of change in cancer risk
Time frame: Up to 12 weeks after enrollment
Diet as mechanism of change in cancer risk
Time frame: Baseline, 6 weeks post-baseline, 12 weeks post-baseline
Momentary Assessment of Anxiety Symptom Changes
Time frame: Up to 12 weeks after enrollment
Momentary Assessment of Depression Symptom Changes
Time frame: Up to 12 weeks after enrollment
Momentary Assessment of Behavioral Avoidance Symptom Changes
Time frame: Up to 12 weeks after enrollment
Momentary Assessment of Hopelessness Symptom Changes
Time frame: Up to 12 weeks after enrollment
Momentary Assessment of Arousal Symptom Changes
Time frame: Up to 12 weeks after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas C Jacobson, PhD principal investigator
Geisel School of Medicine, Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mood Triggers App in people with Depression and Anxiety, run by Trustees of Dartmouth College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in depression as assessed by Patient Health Questionnaire-9 (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.