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

NCT06037382 | Completed

• 1 other identifier: STUDY00032649
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Cancer

Keywords

Cancer Prevention; Passive sensing

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (8)

• Smartphone estimates of sociability as mechanisms of change in cancer risk

  Up to 12 weeks after enrollment

• Smartphone estimates of motion activity as mechanisms of change in cancer risk

  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 Anxiety Symptom Changes

  Up to 12 weeks after enrollment

• Momentary Assessment of Depression Symptom Changes

  Up to 12 weeks after enrollment

Study Arms (1)

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.

Other: Mood Triggers App

Interventions

Mood Triggers App OTHER

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.

MoodTriggers App

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trustees of Dartmouth College: lead
• Norris Cotton Cancer Center: collaborator

Study Sites (1)

Dartmouth College

Hanover, New Hampshire, 03755, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Nicholas C Jacobson, PhD

  Geisel School of Medicine, Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Biomedical Data Science and Psychiatry

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: September 14, 2023
• Study Start: September 25, 2023
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

US (1)