- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06361342
Smartphones Aggravating Anxiety Symptoms
January 13, 2026 updated by: Gagandeep Singh, Mayo Clinic
Smartphones Aggravating Anxiety Symptoms: Experimental Study From Southeastern
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: General decrease in smartphone use.
Subjects will limit their time on smartphone.
|
Subjects will decrease their time on smartphone in general.
|
|
Experimental: Avoid certain social media apps
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.
|
Subjects will avoid use of social media apps on the smartphone which includes Twitter, Facebook, Tik Tok, Instagram, and Pinterest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in anxiety
Time Frame: Day 1, 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in depression
Time Frame: Day 1, 12 weeks
|
Measured using the Patient Health Questionnaire 9-item (PHQ-9) scale used to assess severity of depression.
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 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.
|
Day 1, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gagandeep Singh, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
April 7, 2024
First Submitted That Met QC Criteria
April 7, 2024
First Posted (Actual)
April 11, 2024
Study Record Updates
Last Update Posted (Estimated)
January 14, 2026
Last Update Submitted That Met QC Criteria
January 13, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-003633
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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