AnxietyNCT06138652
Reducing Anxiety Levels Through the Dharma Life App-Based and Mentor-Based Program Targeting Personality Characteristics: A Randomized Control Trial
A study testing App in people with Anxiety, run by Dharma Life Sciences LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate to severe anxiety levels based on the BAI and GAD-7
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- App
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppBehavioural
Participants completed games on an app and sessions with a mentor focused on alleviating anxiety over 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: App |
| Control | No intervention | Participants completed surveys at baseline and again after 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory
Self report survey of anxiety symptoms
Measured: Baseline and after 8 weeks
GAD-7
Self report survey of anxiety symptoms
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Sep 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dharma Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138652
- Sponsor's protocol ID
- Pro00054638
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Anxiety Levels Through the Dharma Life App-Based and Mentor-Based Program Targeting Personality Characteristics: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06138652
- Acronym / sponsor ID
- Pro00054638
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Dharma Life Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App | Experimental | Behavioral: AppParticipants 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. |
| Control | No intervention | –Participants completed surveys at baseline and again after 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe anxiety levels based on the BAI and GAD-7
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AppParticipants completed games on an app and sessions with a mentor focused on alleviating anxiety over 8 weeks. | Behavioural | App |
Primary outcome
Beck Anxiety Inventory
Time frame: Baseline and after 8 weeks
Self report survey of anxiety symptoms
GAD-7
Time frame: Baseline and after 8 weeks
Self report survey of anxiety symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App in people with Anxiety, run by Dharma Life Sciences LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Inventory (time frame: Baseline and after 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.