Smartphones Aggravating Anxiety Symptoms

Anxiety Clinical Trial

Official title:

Smartphones Aggravating Anxiety Symptoms: Experimental Study From Southeastern

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06361342
• Other study ID #: 23-003633
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 8, 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• General decrease in smartphone use
Subjects will decrease their time on smartphone in general.
• Avoiding Social Media Apps
Subjects will avoid use of social media apps on the smartphone which includes Twitter, Facebook, Tik Tok, Instagram, and Pinterest.

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in depression	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