Clinical trial NCT06037382: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Cancer
Keywords: Cancer Prevention
Passive sensing
Lead sponsor: Trustees of Dartmouth College
Sponsor class: OTHER
Collaborators: name: Norris Cotton Cancer Center
First posted: 2023-09-14
Enrollment: 102
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in depression as assessed by Patient Health Questionnaire-9
timeFrame: Baseline
measure: Changes in depression as assessed by Patient Health Questionnaire-9
timeFrame: 6 weeks post-baseline
measure: Changes in depression as assessed by Patient Health Questionnaire-9
timeFrame: 12 weeks post-baseline
measure: Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale
timeFrame: At baseline
measure: Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale
timeFrame: 6 weeks post-baseline
measure: Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale
timeFrame: 12 weeks post-baseline
measure: World Cancer Research Fund (WCRF)/ American Institute for Cancer Research (AICR) Cancer Prevention Score.
timeFrame: Up to 12 weeks after enrollment
Secondary outcomes:
measure: Smartphone estimates of sociability as mechanisms of change in cancer risk
timeFrame: Up to 12 weeks after enrollment
measure: Smartphone estimates of motion activity as mechanisms of change in cancer risk
timeFrame: Up to 12 weeks after enrollment
measure: Diet as mechanism of change in cancer risk
timeFrame: Baseline, 6 weeks post-baseline, 12 weeks post-baseline
measure: Momentary Assessment of Anxiety Symptom Changes
timeFrame: Up to 12 weeks after enrollment
measure: Momentary Assessment of Depression Symptom Changes
timeFrame: Up to 12 weeks after enrollment
measure: Momentary Assessment of Behavioral Avoidance Symptom Changes
timeFrame: Up to 12 weeks after enrollment
measure: Momentary Assessment of Hopelessness Symptom Changes
timeFrame: Up to 12 weeks after enrollment
measure: Momentary Assessment of Arousal Symptom Changes
timeFrame: Up to 12 weeks after enrollment
Other outcomes:
Locations:
city: Hanover
country: United States
facility: Dartmouth College
state: New Hampshire
Study officials:
affiliation: Geisel School of Medicine, Dartmouth College
name: Nicholas C Jacobson, PhD
role: PRINCIPAL_INVESTIGATOR
References: