The Effect of Acute Transcranial Bright Light on Anxiety Symptoms
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Transcranial bright light device
Transcranial sham device
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility 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
Sites / Locations
- Oulu University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Transcranial bright light exposure
Transcranial sham exposure
Arm Description
Transcranially administered bright light exposure for 12 minutes
Transcranially administered sham exposure for 12 minutes
Outcomes
Primary Outcome Measures
Change in total score of STAI-Y1
STAI-Y1 (Spielberger State-Trait Anxiety Inventory, form Y1)
Secondary Outcome Measures
Full Information
NCT ID
NCT01938937
First Posted
September 5, 2013
Last Updated
February 25, 2014
Sponsor
University of Oulu
Collaborators
Valkee Oy
1. Study Identification
Unique Protocol Identification Number
NCT01938937
Brief Title
The Effect of Acute Transcranial Bright Light on Anxiety Symptoms
Official Title
The Effect of Acute Transcranial Bright Light on Anxiety Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
Collaborators
Valkee Oy
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if transcranially administered bright light has acute effect on anxiety symptoms.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcranial bright light exposure
Arm Type
Experimental
Arm Description
Transcranially administered bright light exposure for 12 minutes
Arm Title
Transcranial sham exposure
Arm Type
Sham Comparator
Arm Description
Transcranially administered sham exposure for 12 minutes
Intervention Type
Device
Intervention Name(s)
Transcranial bright light device
Other Intervention Name(s)
Valkee npt 1100
Intervention Type
Device
Intervention Name(s)
Transcranial sham device
Other Intervention Name(s)
Valkee npt 1100
Primary Outcome Measure Information:
Title
Change in total score of STAI-Y1
Description
STAI-Y1 (Spielberger State-Trait Anxiety Inventory, form Y1)
Time Frame
just before exposure, 10 minutes and 110 minutes after the exposure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Oulu University
City
Oulu
ZIP/Postal Code
90014
Country
Finland
12. IPD Sharing Statement
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The Effect of Acute Transcranial Bright Light on Anxiety Symptoms
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