Green Light Effects on Anxiety

NCT04871087 | Unknown

• 1 other identifier: 002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Anxiety

  Changes in anxiety level, as measured by the STAI (State-Trait Anxiety Inventory)

  1 year

Study Arms (1)

Allay lamp (narrow band green light)

OTHER

Comparing effects of NBGL vs. white light on anxiety level before and after psychotherapy treatment sessions.

Device: Green Light

Interventions

Green Light DEVICE

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.

Allay lamp (narrow band green light)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Co-morbid psychiatric conditions

Sponsors & Collaborators

• The Green Light Study Center: lead

Study Sites (1)

Delray Center for Healing

Delray Beach, Florida, 33483, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Paul Hart, MD

CONTACT

561 289 5285; plh7275@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Paul Hart

Model Details: single arm assesment

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 4, 2021
• Study Start: May 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

US (1)