Green Light Effects on Anxiety
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04871087 |
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Recruitment Status :
Recruiting
First Posted : May 4, 2021
Last Update Posted : May 6, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anxiety | Device: Green Light | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | single arm assesment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Narrow Band Green Light (NBGL) Effects on the Treatment of Anxiety During Psychotherapy Sessions: a Pilot Study |
| Estimated Study Start Date : | May 1, 2021 |
| Estimated Primary Completion Date : | April 1, 2022 |
| Estimated Study Completion Date : | April 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Allay lamp (narrow band green light)
Comparing effects of NBGL vs. white light on anxiety level before and after psychotherapy treatment sessions.
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Device: Green Light
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. |
- Anxiety [ Time Frame: 1 year ]Changes in anxiety level, as measured by the STAI (State-Trait Anxiety Inventory)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 95 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Co-morbid psychiatric conditions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04871087
| Contact: Paul Hart, MD | 561 289 5285 | plh7275@gmail.com |
| United States, Florida | |
| Delray Center for Healing | Recruiting |
| Delray Beach, Florida, United States, 33483 | |
| Contact: Paul L Hart, MD 561-289-5285 paulhart46@gmail.com | |
| Responsible Party: | Paul Hart, Dr. Paul Hart, The Green Light Study Center |
| ClinicalTrials.gov Identifier: | NCT04871087 |
| Other Study ID Numbers: |
002 |
| First Posted: | May 4, 2021 Key Record Dates |
| Last Update Posted: | May 6, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Anxiety Disorders Mental Disorders |