- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03698175
Effects of a Brief Mental Exercise on Emotional Processing (BME)
Can Brief Daily Mental Exercises Change the Way the Human Brain Processes Certain Kinds of Information?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oxford, United Kingdom, OX3 7JZ
- University of Oxford
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female or male
- Age: 18 to 65 years
- Good general health
- Competency to give informed consent
Exclusion Criteria:
- 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)
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Three good things exercise
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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.
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Placebo Comparator: Unspecific childhood memory recall exercise
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Performance in a facial expression recognition task
Time Frame: Completed at day 8 after exercise has been started
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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.
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Completed at day 8 after exercise has been started
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Performance in an emotional categorisation task
Time Frame: Completed at day 8 after exercise has been started
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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.
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Completed at day 8 after exercise has been started
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Performance in an emotional faces dot probe task
Time Frame: Completed at day 8 after exercise has been started
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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).
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Completed at day 8 after exercise has been started
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Performance in an emotional recall task
Time Frame: Completed at day 8 after exercise has been started
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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.
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Completed at day 8 after exercise has been started
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Performance in an emotional recognition task
Time Frame: Completed at day 8 after exercise has been started
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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.
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Completed at day 8 after exercise has been started
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Change in cortisol awakening response
Time Frame: Completed at day 8 after exercise has been started
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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).
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Completed at day 8 after exercise has been started
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in subclinical depressive symptoms
Time Frame: Completed at day 8 after exercise has been started
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Center for Epidemiologic Studies Depression Scale Revised.
Standard questionnaire to assess symptoms of depression.
Total score ranging from 0 to 60 with higher scores indicating higher levels of depressive symptoms.
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Completed at day 8 after exercise has been started
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Change in authentic happiness
Time Frame: Completed at day 8 after exercise has been started
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Authentic Happiness Inventory.
Questionnaire developed to assess authentic happiness levels.
Scores ranging from 0 to 120 with higher scores indicating higher happiness levels.
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Completed at day 8 after exercise has been started
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Change in subjective anxiety
Time Frame: Completed at day 8 after exercise has been started
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State-Trait Anxiety Inventory.
Standard questionnaire for subjectively felt anxiety.
Two scores: (1) State anxiety: ranging from 20 to 80 (higher scores indicating higher state anxiety levels).
(2) Trait Anxiety: ranging from 20 to 80 (higher scores indicating higher trait anxiety levels).
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Completed at day 8 after exercise has been started
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Change in subjective mood and energy
Time Frame: Completed at day 8 after exercise has been started
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Zersen's Befindlichkeits-Skala.
Standard questionnaire for subjectively felt mood and energy levels.
Total score ranging from 0 to 112.
Subscores: Mood (ranging from 0 to 94) and Energy (ranging from 0 to 18).
Sum of subscores for mood and energy provide total score.
Higher scores represent worse subjective mood and energy
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Completed at day 8 after exercise has been started
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Change in positive and negative affect
Time Frame: Completed at day 8 after exercise has been started
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Positive and Negative Affect Schedule.
Standard questionnaire for subjectively felt positive and negative affect.
Two scores: (1) Positive score: ranging from 10 to 50 (higher score representing greater extent of positive affect).
(2) Negative score: ranging from 10 to 50 (higher score representing greater extent of negative affect).
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Completed at day 8 after exercise has been started
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Change in subclinical depressive symptoms
Time Frame: Completed at day 8 after exercise has been started
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Beck Depression Inventory.
Standard questionnaire for assessment of depression severity.
Scores ranging from 0 to 63 with higher scores indicating greater depressive severity.
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Completed at day 8 after exercise has been started
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Change in subjective state
Time Frame: Completed at day 8 after exercise has been started
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Visual Analogue Scales of different subjective states (anxious, alert, happy, sad, angry, disgusted, afraid).
Minimum = 0 mm ("Not at all") , Maximum = 96 mm ("Extremely").
Greater scores represent greater extent of felt emotions.
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Completed at day 8 after exercise has been started
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Type of recorded positive events
Time Frame: Completed at day 8 after exercise has been started
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Written records of positive events will be coded according to theme.
Prevalence of each theme will be analysed.
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Completed at day 8 after exercise has been started
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MS IDREC R49254
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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