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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06138652
Other study ID # Pro00054638
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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