Clinical trial NCT04251104: Effectiveness of Personal Relevance of Visual Autobiographical Stimuli in Positive Emotions Induction
Official title: Effectiveness of the Level of Personal Relevance of Visual Autobiographical Stimuli in the Induction of Positive Emotions in Young and Older Adults: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotion Regulation
Mood Induction
Autobiographical Memory
Ageing
Keywords: Images
personal relevance
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
name: European Regional Development Fund
First posted: 2020-01-31
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an exploratory randomized controlled study to compare the effectiveness of three types of autobiographical stimuli, classified according to their level of personal relevance, in the induction of positive emotions resulting from the retrieval of specific positive autobiographical memories. The study sample will comprise a group of adults aged 65 years or over and a group of young adults aged between 18 and 35. Each participant will be assigned randomly to one of three parallel groups (high, medium and low personal relevance images). The allocation ratio will be 1:1:1.
Primary purpose: BASIC_SCIENCE

Brief summary: Background: The ability to retrieve specific memories is a cognitive and emotional protective factor. Among the most effective techniques to generate autobiographical memories is the use of audio-visual stimuli, particularly images. Developing and improving techniques that facilitate the generation of such memories could be highly effective in the prevention of depressive symptoms, especially in the elderly population. The aim of the present study is to examine how the level of personal relevance of pictures as autobiographical memory cues to induce positive emotions may affect an individual's emotion regulation.

Methods: The participants, 120 older adults aged 65 and over and 120 young adults aged between 18 and 35, of both sexes and without depressive symptoms, will be induced to a negative mood state by means of viewing a film clip. Following the negative mood induction, the participants will be shown positive images according to experimental group to which they were randomly assigned (high personal relevance: personal autobiographical photographs; medium personal relevance: pictures of favourite locations associated with specific positive autobiographical memories; and low personal relevance: positive images from the International Affective Picture System). The investigators will analyse the differences in subjective (responses to questionnaires) and objectives measures (EEG signal, heart rate variability and electrodermal activity) between the groups before and after the induction of negative affect and following the recall of positive memories.

Discussion: The use of images associated with specific positive autobiographical memories may be an effective input for inducing positive mood states, which has potentially important implications for their use as a cognitive behavioural technique to treat emotional disorders, such as depression, which are highly prevalent among older adults.


Eligibility criteria: Inclusion Criteria:

1. Older adults will present no symptoms of cognitive impairment. The self-administered Test Your Memory (TYM) will be used to assess cognitive performance \[79,80\].
2. Absence of depressive symptomatology, which will be assessed using the Patient-Reported Outcomes Measurement Information System-Depression \[81\].
3. Given the high comorbidity between anxiety and depression \[82,83\], it was decided that both young and older participants should present no symptoms of anxiety. This will be assessed using the Patient-Reported Outcomes Measurement Information System-Anxiety \[81\].
4. No sensory deficits that might impact performance in the experiment and the psychological tests.
5. Sufficient literacy skills to understand the instructions for the experiment and the psychological tests.
6. Signed informed consent.

Primary outcomes:
measure: Mood state measures: Positive and Negative Affect Schedule (PANAS)
timeFrame: Positive and Negative Affect scales are administered before and after the negative mood induction and before the emotional recovery. The experimental task lasts 25 min. Each scale scores from 10 to 50. Higher scores mean higher affect.
measure: Hemispheric frontal asymmetry in EEG activity
timeFrame: Fast Fourier transformation will be applied to an EEG epoch consisting of the time windows of 30 s each after the onset of the stimulus (film and images) during the experimental task (maximum duration 25 minutes)
measure: EEG power in delta band
timeFrame: Fast Fourier transformation will be applied to an EEG epoch consisting of the time windows of 30 s each after the onset of the stimulus (film and images) during the experimental task (maximum duration 25 minutes)
measure: EEG power in theta band
timeFrame: Fast Fourier transformation will be applied to an EEG epoch consisting of the time windows of 30 s each after the onset of the stimulus (film and images) during the experimental task (maximum duration 25 minutes)
measure: EEG power in alpha band
timeFrame: Fast Fourier transformation will be applied to an EEG epoch consisting of the time windows of 30 s each after the onset of the stimulus (film and images) during the experimental task (maximum duration 25 minutes)
measure: EEG power in beta band
timeFrame: Fast Fourier transformation will be applied to an EEG epoch consisting of the time windows of 30 s each after the onset of the stimulus (film and images) during the experimental task (maximum duration 25 minutes)
measure: EEG power in gamma band
timeFrame: Fast Fourier transformation will be applied to an EEG epoch consisting of the time windows of 30 s each after the onset of the stimulus (film and images) during the experimental task (maximum duration 25 minutes)
measure: Electrodermal activity (EDA) or skin conductance (SC)
timeFrame: Skin conductance is registered during all the experimental task (maximum duration: 25 minutes).
measure: Heart rate variability (HRV)
timeFrame: HRV is registered during all the experimental task (maximum duration: 25 minutes)..
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Fernandez D, Ros L, Sanchez-Reolid R, Ricarte JJ, Latorre JM. Effectiveness of the level of personal relevance of visual autobiographical stimuli in the induction of positive emotions in young and older adults: pilot study protocol for a randomized controlled trial. Trials. 2020 Jul 20;21(1):663. doi: 10.1186/s13063-020-04596-5.