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

• Sponsor: Dharma Life Sciences LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06138652
• Collaborator: (none)
• Enrollment: 73
• Location: 1
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site Per Month: 14.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Behavioral: App	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Reducing Anxiety Levels Through the Dharma Life App-Based and Mentor-Based Program Targeting Personality Characteristics: A Randomized Control Trial
• Actual Study Start Date: Sep 1, 2021
• Actual Primary Completion Date: Jan 31, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: App Participants completed surveys at baseline and again after 8 weeks. Participants completed app-based games and consultation with a mentor over an 8 week period focused on alleviating anxiety.	Behavioral: App; Participants completed games on an app and sessions with a mentor focused on alleviating anxiety over 8 weeks.
No Intervention: Control Participants completed surveys at baseline and again after 8 weeks.

Outcome Measures

Primary Outcome Measures

1. Beck Anxiety Inventory [Baseline and after 8 weeks]

   Self report survey of anxiety symptoms

2. GAD-7 [Baseline and after 8 weeks]

   Self report survey of anxiety symptoms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dharma Life Sciences	New York	New York	United States	10173

Sponsors and Collaborators

• Dharma Life Sciences LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dharma Life Sciences LLC
• ClinicalTrials.gov Identifier: NCT06138652
• Other Study ID Numbers: Pro00054638
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 18, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Nov 18, 2023