Bright Light TreatmentNCT03688048
Effects of a Single Dose of Bright Light Treatment on Measures of Affective Information Processing
A study testing Bright light treatment lamp in people with Bright Light Treatment and Emotion, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bright Light Treatment, Emotion, Facial Expression Recognition
- What is being tested?
- Bright light treatment lamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Feb 2017to 16 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
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- 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)
- The researchers decide to exclude a participant for any other reason (because participation could be harmful to a participant, or a participant can't properly interact with the researchers or could bias the study results)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Non-drug Antidepressant Treatments Influence the Way the Human Brain Processes Information?
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.
Read the detailed description
Background:
Bright light treatment (BLT) is an efficacious treatment for depressive disorders but the causal mechanisms by which it exerts its clinical effects are largely unknown. According to the cognitive neuropsychological model of antidepressant treatment action, one way by which antidepressant treatments lead to clinical effects is by acutely inducing a relatively increased preferential processing of positive (as compared to negative) emotional stimuli. Whether BLT has the potential to induce such positive biases is not known to date.
Aim of study:
To investigate the influence of single-dose BLT on emotion-related information processing in healthy volunteers.
Methods:
Using a double-blind, parallel-group design, fifty healthy volunteers (male and female) were randomly allocated to a single session (60 minutes) of treatment with either bright light (10 000 lux) or a credible placebo-sham condition (deactivated negative ion generator). After treatment, all participants underwent testing with the Oxford Emotional Test Battery, an established battery of behavioural tasks that allow to assess emotional information processing in multiple cognitive domains. This battery consists of a facial expression recognition task, an emotional categorization task, an emotional dot probe task, an emotional recall task and an emotional recognition task. Before and after treatment, subjective state was assessed using different questionnaires.
Hypotheses:
Our working hypothesis, in line with the cognitive neuropsychological model of antidepressant treatment action, is that one-time BLT can induce biases towards positive stimuli in multiple cognitive domains and this bias will be present even in the absence of observable changes in subjective state.
Implications of the study:
This study will show whether a single dose of BLT can influence emotion-related information processing in a similar way as previously observed for antidepressant drugs. If this is the case, then the clinical effects of BLT could be explained through its acute effects on emotional processing. On a broader level, the results of this study will also add to our understanding of any potential effects that acute exposure to bright light (e.g. sunlight) could have on the healthy human mind.
- Being tested
- Bright light treatment lamp, Sham negative ion generator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright light treatment lampDevice
Exposure to bright white light (1 hour, 10 000 lux)
Sham negative ion generatorDevice
Placebo treatment with deactivated negative ion generator (1 hour, audible hum, no ions emitted)
| Study group | Role | What they receive |
|---|---|---|
| Bright light treatment | Experimental | Single-dose bright light treatment (1 hour, 10 000 lux) Receives: Device: Bright light treatment lamp |
| Sham placebo | Placebo comparator | Deactivated negative ion generator in conjunction with a plausible cover story Receives: Device: Sham negative ion generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Completed within 2 hours after treatment
Secondary outcomes (4)
Performance in an emotional categorisation task
Participants are presented with positive and negative personality descriptors and are asked to classify the valence of each word. These words describe either extremely agreeable/positive characteristics (e.g. "cheerful", "honest", "optimistic") or extremely disagreeable/negative characteristics (e.g. "domineering", "untidy", "hostile") and are presented individually in the centre of the screen. Participants are instructed to imagine themselves overhearing someone describing them with each of the words and to indicate as quickly and accurately as possible whether they would like or dislike to be described with each of the words. Responses are made by pressing a correspondingly labelled key on a button box. Reaction times for correct classifications are measured separately for positive and negative words.
Measured: Completed within 2 hours after treatment
Performance in an emotional faces dot probe task
Pictures of positive and negative emotional stimuli (happy and fearful facial expressions) are presented individually together with a matched neutral stimulus (neutral face). On each trial, one stimulus is shown above and the other below a central fixation point. Subsequently, a probe appears behind one of the stimuli and participants have to correctly classify the probe as quickly and as accurately as possible. Stimuli can be masked (i.e. presented very briefly and followed by a jumbled face) or unmasked (i.e. presented for a longer period without a subsequent masking stimulus). Reaction times for correct responses are recorded and vigilance scores are calculated for masked and unmasked positive and negative stimuli by subtracting reaction time data from trials when the probe appeared in the same position as the emotional stimulus (congruent trials) from trials when the probe appeared in the opposite position to the emotional stimulus (incongruent trials).
Measured: Completed within 2 hours after treatment
Performance in an emotional recall task
Following a delay period after the emotional categorization task (about 15 min), emotional recall memory is assessed. Participants are asked to recall and write down as many words as possible from the emotional categorization task. Numbers of correctly and incorrectly recalled positive and negative words are measured.
Measured: Completed within 2 hours after treatment
Performance in an emotional recognition task
Following the emotional recall task, emotional recognition memory is assessed by presenting participants with the original personality descriptors plus an equal number of matched distractor words (50% positive, 50% negative). Participants are asked to indicate for each word as accurately and as quickly as possible whether they recognise it from the emotional categorization task. Numbers of correctly and incorrectly recognised items as well as reaction times for correct recognitions are measured separately for positive and negative words.
Measured: Completed within 2 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start20 Feb 2017
- Primary completion16 Mar 2018
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bright Light TreatmentStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, P1vital Products Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688048
- Sponsor's protocol ID
- MS IDREC R48997
- Status last verified
- Sep 2018
- First submitted
- 18 Sep 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26580307Golden 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.
PubMed 15800134Harmer 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.
PubMed 19648538Roiser 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.
PubMed 21976044
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Non-drug Antidepressant Treatments Influence the Way the Human Brain Processes Information?
- ClinicalTrials.gov ID
- NCT03688048
- Acronym / sponsor ID
- MS IDREC R48997
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Medical Research Council, P1vital Products Limited
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 16 Mar 2018 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Bright light treatment (BLT) is an efficacious treatment for depressive disorders but the causal mechanisms by which it exerts its clinical effects are largely unknown. According to the cognitive neuropsychological model of antidepressant treatment action, one way by which antidepressant treatments lead to clinical effects is by acutely inducing a relatively increased preferential processing of positive (as compared to negative) emotional stimuli. Whether BLT has the potential to induce such positive biases is not known to date.
Aim of study:
To investigate the influence of single-dose BLT on emotion-related information processing in healthy volunteers.
Methods:
Using a double-blind, parallel-group design, fifty healthy volunteers (male and female) were randomly allocated to a single session (60 minutes) of treatment with either bright light (10 000 lux) or a credible placebo-sham condition (deactivated negative ion generator). After treatment, all participants underwent testing with the Oxford Emotional Test Battery, an established battery of behavioural tasks that allow to assess emotional information processing in multiple cognitive domains. This battery consists of a facial expression recognition task, an emotional categorization task, an emotional dot probe task, an emotional recall task and an emotional recognition task. Before and after treatment, subjective state was assessed using different questionnaires.
Hypotheses:
Our working hypothesis, in line with the cognitive neuropsychological model of antidepressant treatment action, is that one-time BLT can induce biases towards positive stimuli in multiple cognitive domains and this bias will be present even in the absence of observable changes in subjective state.
Implications of the study:
This study will show whether a single dose of BLT can influence emotion-related information processing in a similar way as previously observed for antidepressant drugs. If this is the case, then the clinical effects of BLT could be explained through its acute effects on emotional processing. On a broader level, the results of this study will also add to our understanding of any potential effects that acute exposure to bright light (e.g. sunlight) could have on the healthy human mind.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright light treatment | Experimental | Device: Bright light treatment lampSingle-dose bright light treatment (1 hour, 10 000 lux) |
| Sham placebo | Placebo comparator | Device: Sham negative ion generatorDeactivated negative ion generator in conjunction with a plausible cover story |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright light treatment lampExposure to bright white light (1 hour, 10 000 lux) | Device | Bright light treatment |
| Sham negative ion generatorPlacebo treatment with deactivated negative ion generator (1 hour, audible hum, no ions emitted) | Device | Sham placebo |
Primary outcome
Performance in a facial expression recognition task
Time frame: Completed within 2 hours after treatment
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.
4 secondary outcomes
Performance in an emotional categorisation task
Time frame: Completed within 2 hours after treatment
Performance in an emotional faces dot probe task
Time frame: Completed within 2 hours after treatment
Performance in an emotional recall task
Time frame: Completed within 2 hours after treatment
Performance in an emotional recognition task
Time frame: Completed within 2 hours after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Background: PubMed 26580307Lam 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.
- Background: PubMed 15800134Golden 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.
- Background: PubMed 19648538Harmer 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.
- Background: PubMed 21976044Roiser 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright light treatment lamp in people with Bright Light Treatment and Emotion, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance in a facial expression recognition task (time frame: Completed within 2 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03688048, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.