The Effect of Acute Transcranial Bright Light on Anxiety Symptoms

February 25, 2014 updated by: Heidi Jurvelin, University of Oulu
The purpose of this study is to determine if transcranially administered bright light has acute effect on anxiety symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects (n=30) with anxiety symptoms will be recruited into the study. To be included into the study, subjects have to get at least seven points in BAI(Becks Anxiety Inventory). At the beginning of the study subject will be randomly assigned to 12 minutes of acute transcranial bright light or placebo exposure group. Anxiety symptoms will be measured using Spielberger State-Trait Anxiety Inventory (STAI, form Y1)self-rating questionnaire just before and 10 and 110 minutes after the experiment.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90014
        • Oulu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject can read and understand the study protocol
  • The written informed consent is obtained from subject
  • Subject's BAI total score >= 7

Exclusion Criteria:

  • Subject has a lifetime psychotic disorder
  • Subject abuses substance or has a dependence
  • Subject has had suicidal idealization during the past month
  • Subject use psychotropic medications
  • Subject has unstable somatic disease
  • Subject has used bright-light therapy for the current episode
  • Subject is pregnant
  • Subject is a relative of a member of research team
  • Subject has used transcranial light treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial bright light exposure
Transcranially administered bright light exposure for 12 minutes
Device: Transcranial bright light device
Other Names:
  • Valkee npt 1100
Sham Comparator: Transcranial sham exposure
Transcranially administered sham exposure for 12 minutes
Device: Transcranial sham device
Other Names:
  • Valkee npt 1100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total score of STAI-Y1
Time Frame: just before exposure, 10 minutes and 110 minutes after the exposure
STAI-Y1 (Spielberger State-Trait Anxiety Inventory, form Y1)
just before exposure, 10 minutes and 110 minutes after the exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Collaborators

Valkee Oy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 5, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Estimate)

February 26, 2014

Last Update Submitted That Met QC Criteria

February 25, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANX-a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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