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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
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 5, 2013
Last Updated
February 25, 2014
Sponsor
University of Oulu
Collaborators
Valkee Oy
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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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