Reducing Anxiety Levels Through the Dharma Life App-Based and Mentor-Based Program Targeting Personality Characteristics: A Randomized Control Trial

Anxiety Clinical Trial

Official title:

Reducing Anxiety Levels Through the Dharma Life App-Based and Mentor-Based Program Targeting Personality Characteristics: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06138652
• Other study ID #: Pro00054638
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2023
• Source: Dharma Life Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to examine whether an app- and mentor-based program reduced anxiety among individuals reporting difficulties with anxiety.

For the intervention group, this study involved completing an 8-week program focused on helping participants reach their personality goals. The program involved app-based games, journaling, and completing behavioral challenges. Participants engaged with the study app for approximately 15 minutes per day and spoke with a study mentor weekly for 1 hour. Participants were asked to complete surveys prior to and after the program. The pre-program survey lasted approximately 1 hour, and the post-program survey lasted approximately 30 minutes.

For the control group, this study involved completing surveys. Participants were asked to complete surveys 8 weeks apart. The first batch of surveys lasted approximately 1 hour, and the follow-up surveys lasted approximately 30 minutes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate to severe anxiety levels based on the BAI and GAD-7

Exclusion Criteria:

• We excluded participants experiencing any of the following self-reported behaviors in the past 6 months: substance abuse, self-harm, harm or destruction of another person or their property, suicidal ideations, and feeling helpless after the death of a loved one

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• App
Participants completed games on an app and sessions with a mentor focused on alleviating anxiety over 8 weeks.

Locations

Country	Name	City	State
United States	Dharma Life Sciences	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Dharma Life Sciences LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Anxiety Inventory	Self report survey of anxiety symptoms	Baseline and after 8 weeks
Primary	GAD-7	Self report survey of anxiety symptoms	Baseline and after 8 weeks