The Effect of Acute Transcranial Bright Light on Anxiety Symptoms

NCT ID: NCT01938937

Last Updated: 2014-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Transcranial bright light exposure

Transcranially administered bright light exposure for 12 minutes

Group Type EXPERIMENTAL

Transcranial bright light device

Intervention Type DEVICE

Transcranial sham exposure

Transcranially administered sham exposure for 12 minutes

Group Type SHAM_COMPARATOR

Transcranial sham device

Intervention Type DEVICE

Interventions

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Transcranial bright light device

Intervention Type DEVICE

Transcranial sham device

Intervention Type DEVICE

Other Intervention Names

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Valkee npt 1100 Valkee npt 1100

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valkee Oy

INDUSTRY

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Heidi Jurvelin

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oulu University

Oulu, , Finland

Site Status

Countries

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Finland

Other Identifiers

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ANX-a

Identifier Type: -

Identifier Source: org_study_id

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