The Effect of Acute Transcranial Bright Light on Anxiety Symptoms

Anxiety Clinical Trial

Official title:

The Effect of Acute Transcranial Bright Light on Anxiety Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938937
• Other study ID #: ANX-a
• Status: Completed
• Phase: N/A
• First received: September 5, 2013
• Last updated: February 25, 2014
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Device:
• Transcranial bright light device

• Transcranial sham device

Locations

Country	Name	City	State
Finland	Oulu University	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Valkee Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total score of STAI-Y1	STAI-Y1 (Spielberger State-Trait Anxiety Inventory, form Y1)	just before exposure, 10 minutes and 110 minutes after the exposure	No