NCT01938937

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 26, 2014

Status Verified

February 1, 2014

Enrollment Period

1.9 years

First QC Date

September 5, 2013

Last Update Submit

February 25, 2014

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Transcranial bright light exposure

EXPERIMENTAL

Transcranially administered bright light exposure for 12 minutes

Device: Transcranial bright light device

Transcranial sham exposure

SHAM COMPARATOR

Transcranially administered sham exposure for 12 minutes

Device: Transcranial sham device

Interventions

Transcranial bright light deviceDEVICE
Also known as: Valkee npt 1100
Transcranial bright light exposure
Transcranial sham deviceDEVICE
Also known as: Valkee npt 1100
Transcranial sham exposure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject can read and understand the study protocol
  • The written informed consent is obtained from subject
  • Subject's BAI total score \>= 7

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University

Oulu, 90014, Finland

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 10, 2013

Study Start

March 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 26, 2014

Record last verified: 2014-02

Locations

FI(1)