NCT03688048

Brief Summary

This study aims to investigate the effects of a single session of bright light treatment (BLT) on emotional information processing in healthy volunteers. We hypothesised that BLT can acutely push the processing of emotional information towards a prioritisation of positive (relative to negative) input. To test this hypothesis, healthy volunteers were randomly allocated to receive either bright light treatment or sham-placebo treatment and study participants as well as investigators were blind as to which treatment was used. After treatment, all participants underwent testing with the Oxford Emotional Test Battery, an established set of psychological tasks that allow to assess how emotional information is processed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

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

February 20, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
Last Updated

October 3, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

September 18, 2018

Last Update Submit

October 1, 2018

Conditions

Bright Light TreatmentEmotionFacial Expression Recognition

Outcome Measures

Primary Outcomes (1)

  • Performance in a facial expression recognition task

    Participants are presented with individual pictures of facial expressions of emotions. Each presented face displays one of six basic emotions (anger, disgust, fear, happiness, sadness, or surprise). Each emotional expression is presented at different levels of intensity which have been created by combining shape and texture features of the two extremes "neutral" (0%) and "full prototypical emotion" (100%) to varying degrees. Examples of neutral facial expressions are presented as well. Participants are instructed to correctly classify each facial expression as angry, disgusted, fearful, happy, sad, surprised or neutral both as quickly and as accurately as possible. Responses are made by pushing one out of seven labelled keys on a response box. Hit rates, false alarm rates, and reaction times for correct classifications are measured separately for each emotion.

    Completed within 2 hours after treatment

Secondary Outcomes (4)

  • Performance in an emotional categorisation task

    Completed within 2 hours after treatment

  • Performance in an emotional faces dot probe task

    Completed within 2 hours after treatment

  • Performance in an emotional recall task

    Completed within 2 hours after treatment

  • Performance in an emotional recognition task

    Completed within 2 hours after treatment

Other Outcomes (4)

  • Change in subjective mood and energy

    Completed within 2 hours after treatment

  • Change in positive and negative affect

    Completed within 2 hours after treatment

  • Change in subjective anxiety

    Completed within 2 hours after treatment

  • +1 more other outcomes

Study Arms (2)

Bright light treatment

EXPERIMENTAL

Single-dose bright light treatment (1 hour, 10 000 lux)

Device: Bright light treatment lamp

Sham placebo

PLACEBO COMPARATOR

Deactivated negative ion generator in conjunction with a plausible cover story

Device: Sham negative ion generator

Interventions

Bright light treatment lampDEVICE

Exposure to bright white light (1 hour, 10 000 lux)

Bright light treatment
Sham negative ion generatorDEVICE

Placebo treatment with deactivated negative ion generator (1 hour, audible hum, no ions emitted)

Sham placebo

Eligibility Criteria

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

You may not qualify if:

  • Any current or past psychiatric disorder
  • Any first-degree relative with a diagnosis of schizophrenia-spectrum or other psychotic disorder, bipolar disorder, or depressive disorder
  • Any severe medical condition not stabilized at the time of the experiment (e.g. asthma, heart disease)
  • Any condition which precludes treatment with bright light (e.g. retinal disorder, intake of photo-sensitizing medication)
  • Any current or past physical illness that has the potential to significantly affect mental functioning (e.g. stroke, Parkinson's disease)
  • Pregnant, lactating, or sexually active women who do not use any medically accepted method of contraception
  • Any history of seizures or any condition with the potential to manifest with seizures (e.g. epilepsy)
  • Diagnosis of diabetes (because of potential risk of retinal disorder)
  • Current intake of medication that has a significant potential to affect mental functioning, or intake of such medication in the previous 3 months (e.g. antidepressants, neuroleptics, tranquilizers)
  • Any intake of recreational drugs in the last 3 months before the experiment
  • Excessive alcohol consumption up to three days before the experiment
  • Previous use of bright light treatment or negative ion treatment
  • Participant usually (more than 5 days a week) gets up later than 10.00 a.m.
  • Necessity to wear tinted glasses
  • Any kind of sun exposure in the last month that is unusually high for local conditions (e.g. beach vacation, skiing holidays)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford

Oxford, OX3 7JZ, United Kingdom

Location

Related Publications (4)

  • Lam RW, Levitt AJ, Levitan RD, Michalak EE, Cheung AH, Morehouse R, Ramasubbu R, Yatham LN, Tam EM. Efficacy of Bright Light Treatment, Fluoxetine, and the Combination in Patients With Nonseasonal Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jan;73(1):56-63. doi: 10.1001/jamapsychiatry.2015.2235.

    PMID: 26580307BACKGROUND

  • Golden RN, Gaynes BN, Ekstrom RD, Hamer RM, Jacobsen FM, Suppes T, Wisner KL, Nemeroff CB. The efficacy of light therapy in the treatment of mood disorders: a review and meta-analysis of the evidence. Am J Psychiatry. 2005 Apr;162(4):656-62. doi: 10.1176/appi.ajp.162.4.656.

    PMID: 15800134BACKGROUND

  • Harmer CJ, Goodwin GM, Cowen PJ. Why do antidepressants take so long to work? A cognitive neuropsychological model of antidepressant drug action. Br J Psychiatry. 2009 Aug;195(2):102-8. doi: 10.1192/bjp.bp.108.051193.

    PMID: 19648538BACKGROUND

  • Roiser JP, Elliott R, Sahakian BJ. Cognitive mechanisms of treatment in depression. Neuropsychopharmacology. 2012 Jan;37(1):117-36. doi: 10.1038/npp.2011.183. Epub 2011 Oct 5.

    PMID: 21976044BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 27, 2018

Study Start

February 20, 2017

Primary Completion

March 16, 2018

Study Completion

March 16, 2018

Last Updated

October 3, 2018

Record last verified: 2018-09

Locations

GB(1)