NCT06361342

Brief Summary

The goal of this study is to assess if excessive use of smartphone apps of social media can impact a person's mental health. The study is aimed at improving the usage of smartphones which might help improve the mental health of patients. The goal is not to discourage the use of smartphones but instead to utilize smartphones in a way that they do not impact lives.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
7mo left

Started Mar 2024

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Mar 2024Dec 2026

Study Start

First participant enrolled

March 8, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

April 7, 2024

Last Update Submit

January 13, 2026

Conditions

Keywords

Smartphones

Outcome Measures

Primary Outcomes (1)

  • Change in anxiety

    Measured using the General Anxiety Disorder 7-item (GAD 7) scale to assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety.

    Day 1, 12 weeks

Secondary Outcomes (1)

  • Change in depression

    Day 1, 12 weeks

Study Arms (2)

General decrease in smartphone use.

EXPERIMENTAL

Subjects will limit their time on smartphone.

Behavioral: General decrease in smartphone use

Avoid certain social media apps

EXPERIMENTAL

Subjects will limit time on smartphone, in particular avoiding use of social media apps on the smartphone which includes Twitter, Facebook, Tik Tok, Instagram, and Pinterest.

Behavioral: Avoiding Social Media Apps

Interventions

Subjects will decrease their time on smartphone in general.

General decrease in smartphone use.

Subjects will avoid use of social media apps on the smartphone which includes Twitter, Facebook, Tik Tok, Instagram, and Pinterest.

Avoid certain social media apps

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For patients aged 18 years or older experiencing mild symptoms of anxiety or depression and who have a GAD-7 score 5 and above.
  • Patient should have smart phone and should be using Facebook, Instagram, Twitter, Tik Tok, and Pinterest social media apps.
  • Patients should have email access.

You may not qualify if:

  • Any patient who uses a smartphone for tracking glucose for diabetes management, heart rate, or any chronic illness which is being managed through a smartphone app.
  • Any patient who uses more than one personal smartphone
  • Any patient who is a suicide risk as per PHQ-9 score, current recreational drug usage, or alcohol abuse.
  • Any patient who has suicidal ideation as per PHQ-9 assessment before or during the study period will be excluded, (all patients will be monitored for suicidal ideation by PHQ-9 scoring method at day 1, week 6, and week 12, but it is the responsibility of the patient to inform the study team if they have developed any suicidal ideation throughout the study period).
  • Patients with activated POA (Power of Attorney - Healthcare), diagnosis of mental retardation or current disability due to any psychiatric disorder or severe depression with a high risk of suicide should be excluded.
  • Any patient currently undergoing ECT (electroconvulsive therapy) for severe depression.
  • Any patient taking prescribed SSRIs/SNRIs, with a change and not taking them continuously in last 30 days (not a new diagnosis of anxiety). If change they will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Gagandeep Singh, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2024

First Posted

April 11, 2024

Study Start

March 8, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations