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Clinical Trials/NCT06037382
NCT06037382
Completed
N/A

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

Trustees of Dartmouth College1 site in 1 country102 target enrollmentSeptember 25, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
Trustees of Dartmouth College
Enrollment
102
Locations
1
Primary Endpoint
Changes in depression as assessed by Patient Health Questionnaire-9
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 25, 2023
End Date
March 6, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicholas Jacobson

Assistant Professor of Biomedical Data Science and Psychiatry

Trustees of Dartmouth College

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.

Outcomes

Primary Outcomes

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: 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.

Secondary Outcomes

  • Smartphone estimates of sociability as mechanisms of change in cancer risk(Up to 12 weeks after enrollment)
  • Momentary Assessment of Anxiety Symptom Changes(Up to 12 weeks after enrollment)
  • Momentary Assessment of Behavioral Avoidance Symptom Changes(Up to 12 weeks after enrollment)
  • Diet as mechanism of change in cancer risk(Baseline, 6 weeks post-baseline, 12 weeks post-baseline)
  • Momentary Assessment of Arousal Symptom Changes(Up to 12 weeks after enrollment)
  • Momentary Assessment of Depression Symptom Changes(Up to 12 weeks after enrollment)
  • Momentary Assessment of Hopelessness Symptom Changes(Up to 12 weeks after enrollment)
  • Smartphone estimates of motion activity as mechanisms of change in cancer risk(Up to 12 weeks after enrollment)

Study Sites (1)

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