Green Light Effects on Anxiety

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety
• Intervention / Treatment: Device: Green Light

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul Hart, MD; Phone Number: 561 289 5285; Email: plh7275@gmail.com

Study Locations

• United States
  • Florida
    • Delray Beach, Florida, United States, 33483
      • Recruiting
      • Delray Center for Healing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Allay lamp (narrow band green light); Comparing effects of NBGL vs. white light on anxiety level before and after psychotherapy treatment sessions.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Changes in anxiety level, as measured by the STAI (State-Trait Anxiety Inventory)	1 year

Collaborators and Investigators

• Sponsor: The Green Light Study Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No