- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04251104
Effectiveness of Personal Relevance of Visual Autobiographical Stimuli in Positive Emotions Induction
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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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].
- Absence of depressive symptomatology, which will be assessed using the Patient-Reported Outcomes Measurement Information System-Depression [81].
- 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].
- No sensory deficits that might impact performance in the experiment and the psychological tests.
- Sufficient literacy skills to understand the instructions for the experiment and the psychological tests.
- Signed informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Level of personal relevance of images
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 (high, medium and low), in the induction of positive emotions resulting from the retrieval of specific positive autobiographical memories.
To this end, the investigators will use three types of images, classified according to their personal relevance: a) personal autobiographical photographs (high personal relevance); b) images of locations related to the participants' lives (medium personal relevance); and c) images from the Internation Affective Picture System (IAPS; low personal relevance).
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After completing the PANAS, the negative mood induction phase (viewing a film clip) phase will begin. Before this phase, the participants will be encouraged to experience the feelings generated by the clip as intensely as possible. After viewing the film clip, participants will be asked to complete the PANAS again in order to assess the effectiveness of the negative mood induction procedure. Following the negative mood induction phase, the emotional recovery phase will be initiated, in which the participants will look at a total of six pictures previously selected according to their experimental condition in order to generate specific positive autobiographical memories. At the end of this phase, participants will once more complete the PANAS in order to assess the effectiveness of the emotional recovery. |
Other: Age (young and older adults comparison)
To analyse any age-related differences in the effectiveness of the use of the three types of images to regulate emotion, the investigators will compare the efficacy of the three categories of pictures (high, medium and low relevance) in inducing positive mood states in a group of young adults (age range: 18-35 years) and a group of older adults (65 years or over).
|
After completing the PANAS, the negative mood induction phase (viewing a film clip) phase will begin. Before this phase, the participants will be encouraged to experience the feelings generated by the clip as intensely as possible. After viewing the film clip, participants will be asked to complete the PANAS again in order to assess the effectiveness of the negative mood induction procedure. Following the negative mood induction phase, the emotional recovery phase will be initiated, in which the participants will look at a total of six pictures previously selected according to their experimental condition in order to generate specific positive autobiographical memories. At the end of this phase, participants will once more complete the PANAS in order to assess the effectiveness of the emotional recovery. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mood state measures: Positive and Negative Affect Schedule (PANAS)
Time Frame: 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.
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Assessment of positive and negative affect during the experimental phase
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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.
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Hemispheric frontal asymmetry in EEG activity
Time Frame: 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)
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Left frontal (F3, F7, FC5) and right frontal (F4, F8, FC6) electrode pools will be formed by averaging the frequency distributions of these signals
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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)
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EEG power in delta band
Time Frame: 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)
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The mean magnitud of delta frequency band activity will be calculated for each participant during each event type (film and images).
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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)
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EEG power in theta band
Time Frame: 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)
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The mean magnitud of theta frequency band activity will be calculated for each participant during each event type (film and images).
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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)
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EEG power in alpha band
Time Frame: 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)
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The mean magnitud of alpha frequency band activity will be calculated for each participant during each event type (film and images).
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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)
|
EEG power in beta band
Time Frame: 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)
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The mean magnitud of beta frequency band activity will be calculated for each participant during each event type (film and images).
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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)
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EEG power in gamma band
Time Frame: 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)
|
The mean magnitud of gamma frequency band activity will be calculated for each participant during each event type (film and images).
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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)
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Electrodermal activity (EDA) or skin conductance (SC)
Time Frame: Skin conductance is registered during all the experimental task (maximum duration: 25 minutes).
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SC morphology is the result of two independent components: a fast-changing skin conductance response (SCR), overlapped with a slowly changing skin conductance level component (SCL).
The SCL component ranges from 0Hz to 0.05Hz, while SCR ranges from 0.05Hz to 1.5 Hz.
Each SC signal will be filtered by applying a 1.5Hz cut-off low-pass FIR filter to decrease noise generated during the acquisition.
The data series will first be divided into equal segments lasting five seconds and the mean of each segment will be recorded for subsequent analysis.
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Skin conductance is registered during all the experimental task (maximum duration: 25 minutes).
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Heart rate variability (HRV)
Time Frame: HRV is registered during all the experimental task (maximum duration: 25 minutes)..
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Cardiovascular variables will be measured through blood volume pressure (BVP).
Alternations of the BVP waveform are highly correlated with heart ventricular depolarization and repolarization, thus being suitable to measure heart rhythm.
Once data are acquired, BVP signals will be processed to reduce noise.
After that, interbeat intervals (IBIs) will be derived from the peak-data series.
The IBI data series will be transformed to obtain the heart rate (HR) measured in beats per minute (BPM).
Then, the HR metric will be partitioned into five-second equally-separated segments.
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HRV is registered during all the experimental task (maximum duration: 25 minutes)..
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- SBPLY/19/180501/000181
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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