Emotional Processing Clinical Trial
— BMEOfficial title:
Can Brief Daily Mental Exercises Change the Way the Human Brain Processes Certain Kinds of Information?
| Verified date | September 2018 |
| Source | University of Oxford |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | October 10, 2018 |
| Est. primary completion date | October 10, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: 1. Female or male 2. Age: 18 to 65 years 3. Good general health 4. Competency to give informed consent Exclusion Criteria: 1. Any current or past psychiatric disorder 2. Any first-degree relative with a diagnosis of schizophrenia-spectrum or other psychotic disorder, bipolar disorder, or depressive disorder 3. 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. 4. Regular engagement in any of the exercises outlined above within the last 6 months. 5. Any severe medical condition not stabilized at the time of the study (e.g. asthma, heart disease, epilepsy) 6. Any current or past physical illness that has the potential to significantly affect mental functioning (e.g. stroke, Parkinson's disease, multiple sclerosis) 7. 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) 8. Any intake of recreational drugs in the last 3 months before the experiment 9. 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) 10. Any other reasons that preclude participants from full participation in the experiment (e.g. insufficient knowledge of English language) 11. 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) |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Oxford | Oxford |
| Lead Sponsor | Collaborator |
|---|---|
| University of Oxford |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in subclinical depressive symptoms | 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. | Completed at day 8 after exercise has been started | |
| Other | Change in authentic happiness | Authentic Happiness Inventory. Questionnaire developed to assess authentic happiness levels. Scores ranging from 0 to 120 with higher scores indicating higher happiness levels. | Completed at day 8 after exercise has been started | |
| Other | Change in subjective anxiety | 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). | Completed at day 8 after exercise has been started | |
| Other | Change in subjective mood and energy | 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 | Completed at day 8 after exercise has been started | |
| Other | Change in positive and negative affect | 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). | Completed at day 8 after exercise has been started | |
| Other | Change in subclinical depressive symptoms | Beck Depression Inventory. Standard questionnaire for assessment of depression severity. Scores ranging from 0 to 63 with higher scores indicating greater depressive severity. | Completed at day 8 after exercise has been started | |
| Other | Change in subjective state | 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. | Completed at day 8 after exercise has been started | |
| Other | Type of recorded positive events | Written records of positive events will be coded according to theme. Prevalence of each theme will be analysed. | Completed at day 8 after exercise has been started | |
| Primary | 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 at day 8 after exercise has been started | |
| Secondary | 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. | Completed at day 8 after exercise has been started | |
| Secondary | 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). | Completed at day 8 after exercise has been started | |
| Secondary | 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. | Completed at day 8 after exercise has been started | |
| Secondary | 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. | Completed at day 8 after exercise has been started | |
| Secondary | 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). | Completed at day 8 after exercise has been started |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
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