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The Effect of Acute Transcranial Bright Light on Anxiety Symptoms

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01938937
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : February 26, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if transcranially administered bright light has acute effect on anxiety symptoms.

Condition or disease Intervention/treatment
Anxiety Device: Transcranial bright light device Device: Transcranial sham device

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Acute Transcranial Bright Light on Anxiety Symptoms
Study Start Date : March 2012
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Transcranial bright light exposure
Transcranially administered bright light exposure for 12 minutes
Device: Transcranial bright light device
Other Name: Valkee npt 1100
Sham Comparator: Transcranial sham exposure
Transcranially administered sham exposure for 12 minutes
Device: Transcranial sham device
Other Name: Valkee npt 1100


Outcome Measures

Primary Outcome Measures :
  1. 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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT01938937


Locations
Finland
Oulu University
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
Valkee Oy
More Information

Responsible Party: Heidi Jurvelin, PhD student, University of Oulu
ClinicalTrials.gov Identifier: NCT01938937     History of Changes
Other Study ID Numbers: ANX-a
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders