Emotional ProcessingBMENCT03698175
Effects of a Brief Mental Exercise on Emotional Processing
A study testing Three good things exercise in people with Emotional Processing and Mental Exercise, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The aim of this study is to explore whether a brief mental exercise (developed and widely advocated in the field of positive psychology) can change the processing of emotion-related information in a similar way as previously observed for antidepressant drugs. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Processing, Mental Exercise
- What is being tested?
- Three good things exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2017to 10 Oct 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
- Female or male
- Age: 18 to 65 years
- Good general health
- Competency to give informed consent
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
- Regular engagement in mental exercises specifically aimed at improving cognitive abilities (concentration, attention, memory etc.), mood, or general well-being, such as (online) cognitive training, positive psychology exercises, regular meditation or mindfulness practices, yoga practices, or psychotherapeutic exercises.
- Regular engagement in any of the exercises outlined above within the last 6 months.
- Any severe medical condition not stabilized at the time of the study (e.g. asthma, heart disease, epilepsy)
- Any current or past physical illness that has the potential to significantly affect mental functioning (e.g. stroke, Parkinson's disease, multiple sclerosis)
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- 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
- Regular consumption of higher doses of alcohol (more than 2 pints of beer or equivalent on more than 3 days a week within the last month)
- Any other reasons that preclude participants from full participation in the experiment (e.g. insufficient knowledge of English language)
- Any other condition which can make participation in the study harmful for a participant, or which can severely compromise the quality of the data (e.g. low intellectual functioning)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Brief Daily Mental Exercises Change the Way the Human Brain Processes Certain Kinds of Information?
The aim of this study is to explore whether a brief mental exercise (developed and widely advocated in the field of positive psychology) can change the processing of emotion-related information in a similar way as previously observed for antidepressant drugs. Healthy volunteers are randomly allocated to a 7-day practice of the "Three Good Things" (TGT) exercise or a previously used placebo exercise (unspecified childhood memory recall) with study participants as well as investigators being blind as to which practice is conducted. After a 7-day practice period, all study participants undergo testing with the Oxford Emotional Test Battery, an established battery of cognitive tasks that allow to assess how emotional information is processed. The working hypothesis of the study is that the TGT exercise, as compared to the placebo exercise, can push the processing of emotional information towards a prioritisation of positive (relative to negative) input.
Read the detailed description
Background and objective:
Previous research indicates that various physiological treatments for depression (especially antidepressant drugs) can induce positive biases in emotional information processing and it has been suggested that this might be a crucial common mechanism through which they exert their clinical effects. This study aims to investigate whether similar positive biases can also be induced by a brief mental exercise (developed and widely used within the field of positive psychology) that has previously been shown to have antidepressant and/or happiness-enhancing effects.
Methods:
Using a double-blind, parallel-group design, 100 healthy volunteers (male and female) are randomly allocated to a 7-day mental exercise practice conducting either the widely reported Three Good Things (TGT) exercise or a previously established placebo condition (unspecific childhood memory recall). After 7 days of practice, all participants undergo testing with the Oxford Emotional Test Battery in order to assess emotional information processing in different 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. In addition, prior to and immediately after the 7-day practice period salivary cortisol awakening response and subjective state (using various questionnaires) is assessed.
Hypotheses:
The working hypothesis of the study is that, similar to physiological antidepressant interventions, the TGT exercise (as compared to the placebo exercise) might induce biases towards positive stimuli in multiple cognitive domains.
Implications of the study:
This study will show whether engaging in a simple mental exercise can alter emotional information processing in a similar way as previously observed for antidepressant drugs and other physiological interventions.
- Conditions
- Emotional Processing, Mental Exercise
- Being tested
- Three good things exercise, Placebo exercise
- Keywords
- Emotion, Cognition, Positive psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three good things exerciseBehavioural
Participants are asked to remember each evening three things that went well during their day and to write them down in a journal including a short explanation of why they think each of them has happened.
Placebo exerciseBehavioural
Participants are asked to briefly recall a childhood memory (no further specification) and to write it down including a short explanation why they think it has happened.
| Study group | Role | What they receive |
|---|---|---|
| Three good things exercise | Experimental | Not described Receives: Behavioral: Three good things exercise |
| Unspecific childhood memory recall exercise | Placebo comparator | Not described Receives: Behavioral: Placebo exercise |
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 at day 8 after exercise has been started
Secondary outcomes (5)
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 at day 8 after exercise has been started
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 at day 8 after exercise has been started
Performance in an emotional recall task
Following a delay period after the emotional categorisation 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 at day 8 after exercise has been started
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 at day 8 after exercise has been started
Change in cortisol awakening response
Salivary cortisol is assessed prior to and after completion of the 7-day exercise period. For each assessment, participants have to provide five saliva samples taken in their own home (0, 15, 30, 45, and 60 minutes after awakening).
Measured: Completed at day 8 after exercise has been started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start24 May 2017
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional ProcessingStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698175
- Sponsor's protocol ID
- MS IDREC R49254
- Acronym
- BME
- Status last verified
- Sep 2018
- First submitted
- 4 Oct 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Brief Daily Mental Exercises Change the Way the Human Brain Processes Certain Kinds of Information?
- ClinicalTrials.gov ID
- NCT03698175
- Acronym / sponsor ID
- BME / MS IDREC R49254
- Conditions
- Emotional Processing, Mental Exercise
- Keywords
- Emotion, Cognition, Positive psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 5 Oct 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.
The aim of this study is to explore whether a brief mental exercise (developed and widely advocated in the field of positive psychology) can change the processing of emotion-related information in a similar way as previously observed for antidepressant drugs. Healthy volunteers are randomly allocated to a 7-day practice of the "Three Good Things" (TGT) exercise or a previously used placebo exercise (unspecified childhood memory recall) with study participants as well as investigators being blind as to which practice is conducted. After a 7-day practice period, all study participants undergo testing with the Oxford Emotional Test Battery, an established battery of cognitive tasks that allow to assess how emotional information is processed. The working hypothesis of the study is that the TGT exercise, as compared to the placebo exercise, can push the processing of emotional information towards a prioritisation of positive (relative to negative) input.
Detailed description
Background and objective:
Previous research indicates that various physiological treatments for depression (especially antidepressant drugs) can induce positive biases in emotional information processing and it has been suggested that this might be a crucial common mechanism through which they exert their clinical effects. This study aims to investigate whether similar positive biases can also be induced by a brief mental exercise (developed and widely used within the field of positive psychology) that has previously been shown to have antidepressant and/or happiness-enhancing effects.
Methods:
Using a double-blind, parallel-group design, 100 healthy volunteers (male and female) are randomly allocated to a 7-day mental exercise practice conducting either the widely reported Three Good Things (TGT) exercise or a previously established placebo condition (unspecific childhood memory recall). After 7 days of practice, all participants undergo testing with the Oxford Emotional Test Battery in order to assess emotional information processing in different 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. In addition, prior to and immediately after the 7-day practice period salivary cortisol awakening response and subjective state (using various questionnaires) is assessed.
Hypotheses:
The working hypothesis of the study is that, similar to physiological antidepressant interventions, the TGT exercise (as compared to the placebo exercise) might induce biases towards positive stimuli in multiple cognitive domains.
Implications of the study:
This study will show whether engaging in a simple mental exercise can alter emotional information processing in a similar way as previously observed for antidepressant drugs and other physiological interventions.
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 |
|---|---|---|
| Three good things exercise | Experimental | Behavioral: Three good things exercise |
| Unspecific childhood memory recall exercise | Placebo comparator | Behavioral: Placebo exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female or male
- Age: 18 to 65 years
- Good general health
- Competency to give informed consent
Key exclusion criteria (11 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
- Regular engagement in mental exercises specifically aimed at improving cognitive abilities (concentration, attention, memory etc.), mood, or general well-being, such as (online) cognitive training, positive psychology exercises, regular meditation or mindfulness practices, yoga practices, or psychotherapeutic exercises.
- Regular engagement in any of the exercises outlined above within the last 6 months.
- Any severe medical condition not stabilized at the time of the study (e.g. asthma, heart disease, epilepsy)
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 |
|---|---|---|
| Three good things exerciseParticipants are asked to remember each evening three things that went well during their day and to write them down in a journal including a short explanation of why they think each of them has happened. | Behavioural | Three good things exercise |
| Placebo exerciseParticipants are asked to briefly recall a childhood memory (no further specification) and to write it down including a short explanation why they think it has happened. | Behavioural | Unspecific childhood memory recall exercise |
Primary outcome
Performance in a facial expression recognition task
Time frame: Completed at day 8 after exercise has been started
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.
5 secondary outcomes
Performance in an emotional categorisation task
Time frame: Completed at day 8 after exercise has been started
Performance in an emotional faces dot probe task
Time frame: Completed at day 8 after exercise has been started
Performance in an emotional recall task
Time frame: Completed at day 8 after exercise has been started
Performance in an emotional recognition task
Time frame: Completed at day 8 after exercise has been started
Change in cortisol awakening response
Time frame: Completed at day 8 after exercise has been started
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 18 Apr 2019.
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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 Three good things exercise in people with Emotional Processing and Mental Exercise, 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 4 inclusion and 11 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 18 Apr 2019. 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 at day 8 after exercise has been started). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2019.