Recruiting

Green Light

Sponsor:

The Green Light Study Center

Code:

NCT04871087

Conditions

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Green Light

Study Details

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

Study ID

NCT04871087

Start date

May 1, 2021

Status verified date

Mar, 2022

Completion date

Apr 1, 2022

Anticipated

Primary completion date

Apr 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Allay lamp (narrow band green light)

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

Interventions

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.

Primary outcome measure

  • Anxiety [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Paul Hart, MD

561 289 5285plh7275@gmail.com

Locations

Delray Center for Healing

Recruiting

Delray Beach, Florida, United States, 33483

Contacts

Paul L Hart, MD

561-289-5285paulhart46@gmail.com

More Information

Sponsor

The Green Light Study Center

Last update posted

Mar 15, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Green Light Study Center on 2022-03-15.