AnxietyNCT04871087
Green Light Effects on Anxiety
A study testing Green Light in people with Anxiety, run by The Green Light Study Center at 1 site in United States.
Trial summary
The main goal of this study is to determine whether exposure to a narrow band of green light (NBGL) improves outcome of psychotherapy sessions for the treatment of anxiety. This is a within-subject study design that examines NBGL effects (as compared to white light) on anxiety level and treatment success, as evaluated… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Green Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 1 Apr 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of anxiety
- Being a patient at the Delray Center
- Older than 18 and younger than 95
- Being able to communicate in English
- Willingness to sign informed consent
Who cannot join
- Co-morbid psychiatric conditions
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Delray Center for Healing
Delray Beach, Florida, 33483
Paul L Hart, MD, 561-289-5285, paulhart46@gmail.com
About this study
Official title: Narrow Band Green Light (NBGL) Effects on the Treatment of Anxiety During Psychotherapy Sessions: a Pilot Study
The main goal of this study is to determine whether exposure to a narrow band of green light (NBGL) improves outcome of psychotherapy sessions for the treatment of anxiety.
This is a within-subject study design that examines NBGL effects (as compared to white light) on anxiety level and treatment success, as evaluated by the treating psychotherapist and the patient. For each participant, the study will consist of 8 therapy sessions, each lasting 60 minutes, in which light conditions will be presented in the following order
Read more
Session 1: White light, Session 2: white light, Session 3: NBGL (i.e., green light), Session 4: NBGL, Session 5: NBGL, Session 6: NBGL, Session 7: White light, Session 8: White light
Effects of lights (white vs.NBGL) on anxiety level will be evaluated at the beginning and end of each therapy session by the patient, using a validated questionnaire. At the end of each session, the treating psychotherapist will fill another evaluation form that summarizes her/his impression of the treatment success or lack of.
Read the detailed description
Each patient is treated once a week and thus, study participation time is expected to last 8 weeks. Patients will self evaluate their anxiety level at the beginning and end of each of the 8 therapy sessions by completing the 20-questions State-Trait Anxiety Inventory (STAI Form Y-1).
Therapists will fill the following form after each of the 8 sessions:
Did you feel any difference while working with the patient in the green light as compared to regular room light?
Check all that apply:
- I was more focused
- I was more relaxed
- The patient was more relaxed
- The patient was more engaged
- The patient seemed more open
- The therapy progressed further
- Conditions
- Anxiety
- Being tested
- Green Light
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green LightDevice
The Allay Lamp is a consumer product currently available and widely used in the US. It emits low intensity (1-10lux)narrow band (20nm) green light (peak wavelength 520nm) that is marketed as non-irritating to users. In that context, it is not a medical device and does not require a 510(k). However, we believe that light likely also has benefits for sleep. To better understand its effects,we are planning to conduct the proposed study. In that context, the Allay Lamp would be considered an investigational medical device because it has not been cleared or approved by FDA for the intended purpose of treating sleep. No FDA submission should be necessary for this study using 21 C.F.R. 812.3, because the Allay Lamp is a non-significant risk (NSR) device:
It is not an implant It is not intended for use in supporting or sustaining human life The Allay Lamp provides a very low risk light-based therapy. The light provides no more risk than any other table lamp available on the market today.
| Study group | Role | What they receive |
|---|---|---|
| Allay lamp (narrow band green light) | Other | Comparing effects of NBGL vs. white light on anxiety level before and after psychotherapy treatment sessions. Receives: Device: Green Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Changes in anxiety level, as measured by the STAI (State-Trait Anxiety Inventory)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 May 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm assesment
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Green Light Study Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Hart, The Green Light Study Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871087
- Sponsor's protocol ID
- 002
- Status last verified
- Mar 2022
- First submitted
- 23 Apr 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrow Band Green Light (NBGL) Effects on the Treatment of Anxiety During Psychotherapy Sessions: a Pilot Study
- ClinicalTrials.gov ID
- NCT04871087
- Acronym / sponsor ID
- 002
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Green Light Study CenterUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 4 May 2021 (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 main goal of this study is to determine whether exposure to a narrow band of green light (NBGL) improves outcome of psychotherapy sessions for the treatment of anxiety.
This is a within-subject study design that examines NBGL effects (as compared to white light) on anxiety level and treatment success, as evaluated by the treating psychotherapist and the patient. For each participant, the study will consist of 8 therapy sessions, each lasting 60 minutes, in which light conditions will be presented in the following order
Session 1: White light, Session 2: white light, Session 3: NBGL (i.e., green light), Session 4: NBGL, Session 5: NBGL, Session 6: NBGL, Session 7: White light, Session 8: White light
Effects of lights (white vs.NBGL) on anxiety level will be evaluated at the beginning and end of each therapy session by the patient, using a validated questionnaire. At the end of each session, the treating psychotherapist will fill another evaluation form that summarizes her/his impression of the treatment success or lack of.
Detailed description
Each patient is treated once a week and thus, study participation time is expected to last 8 weeks. Patients will self evaluate their anxiety level at the beginning and end of each of the 8 therapy sessions by completing the 20-questions State-Trait Anxiety Inventory (STAI Form Y-1).
Therapists will fill the following form after each of the 8 sessions:
Did you feel any difference while working with the patient in the green light as compared to regular room light?
Check all that apply:
- I was more focused
- I was more relaxed
- The patient was more relaxed
- The patient was more engaged
- The patient seemed more open
- The therapy progressed further
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm assesment
| Arm | Type | Receives |
|---|---|---|
| Allay lamp (narrow band green light) | Other | Device: Green LightComparing effects of NBGL vs. white light on anxiety level before and after psychotherapy treatment sessions. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of anxiety
- Being a patient at the Delray Center
- Older than 18 and younger than 95
- Being able to communicate in English
- Willingness to sign informed consent
Key exclusion criteria (1 listed)
- Co-morbid psychiatric conditions
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 |
|---|---|---|
| Green LightThe Allay Lamp is a consumer product currently available and widely used in the US. It emits low intensity (1-10lux)narrow band (20nm) green light (peak wavelength 520nm) that is marketed as non-irritating to users. In that context, it is not a medical device and does not require a 510(k). However, we believe that light likely also has benefits for sleep. To better understand its effects,we are planning to conduct the proposed study. In that context, the Allay Lamp would be considered an investigational medical device because it has not been cleared or approved by FDA for the intended purpose of treating sleep. No FDA submission should be necessary for this study using 21 C.F.R. 812.3, because the Allay Lamp is a non-significant risk (NSR) device: It is not an implant It is not intended for use in supporting or sustaining human life The Allay Lamp provides a very low risk light-based therapy. The light provides no more risk than any other table lamp available on the market today. | Device | Allay lamp (narrow band green light) |
Primary outcome
Anxiety
Time frame: 1 year
Changes in anxiety level, as measured by the STAI (State-Trait Anxiety Inventory)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Anxiety
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
VITAL - Virginia Tech Accelerated Holographic LIFU for Anxiety
Anxiety
Not yet recruiting
Music for Reducing Anxiety Before Surgery
Preoperative Anxiety
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Light in people with Anxiety, run by The Green Light Study Center 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 5 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: status not confirmed, as of the sponsor's last update on 15 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Hart, MD (561 289 5285, plh7275@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 1 year). 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 15 Mar 2022.