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

NCT06138652 | Completed

• 1 other identifier: Pro00054638
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (2)

• Beck Anxiety Inventory

  Self report survey of anxiety symptoms

  Baseline and after 8 weeks

• GAD-7

  Self report survey of anxiety symptoms

  Baseline and after 8 weeks

Study Arms (2)

App

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants completed surveys at baseline and again after 8 weeks.

Interventions

App BEHAVIORAL

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

App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dharma Life Sciences LLC: lead

Study Sites (1)

Dharma Life Sciences

New York, New York, 10173, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: September 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)