Emotion RegulationNCT04251104
Effectiveness of Personal Relevance of Visual Autobiographical Stimuli in Positive Emotions Induction
A study testing Images' personal relevance effectiveness in objective and subjective mood recovery in people with Emotion Regulation and Mood Induction, run by University of Castilla-La Mancha.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation, Mood Induction, Autobiographical Memory
- What is being tested?
- Images' personal relevance effectiveness in objective and subjective mood recovery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Apr 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
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
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.
- Conditions
- Emotion Regulation, Mood Induction, Autobiographical Memory, Ageing
- Being tested
- Images' personal relevance effectiveness in objective and subjective mood recovery
- Keywords
- Images, personal relevance
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Images' personal relevance effectiveness in objective and subjective mood recoveryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Level of personal relevance of images | Experimental | 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). Receives: Other: Images' personal relevance effectiveness in objective and subjective mood recovery |
| Age (young and older adults comparison) | Other | 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). Receives: Other: Images' personal relevance effectiveness in objective and subjective mood recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood state measures: Positive and Negative Affect Schedule (PANAS)
Assessment of positive and negative affect during the experimental phase
Measured: 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.
Hemispheric frontal asymmetry in EEG activity
Left frontal (F3, F7, FC5) and right frontal (F4, F8, FC6) electrode pools will be formed by averaging the frequency distributions of these signals
Measured: 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 delta band
The mean magnitud of delta frequency band activity will be calculated for each participant during each event type (film and images).
Measured: 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 theta band
The mean magnitud of theta frequency band activity will be calculated for each participant during each event type (film and images).
Measured: 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 alpha band
The mean magnitud of alpha frequency band activity will be calculated for each participant during each event type (film and images).
Measured: 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
The mean magnitud of beta frequency band activity will be calculated for each participant during each event type (film and images).
Measured: 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 gamma band
The mean magnitud of gamma frequency band activity will be calculated for each participant during each event type (film and images).
Measured: 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)
Electrodermal activity (EDA) or skin conductance (SC)
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.
Measured: Skin conductance is registered during all the experimental task (maximum duration: 25 minutes).
Heart rate variability (HRV)
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.
Measured: HRV is registered during all the experimental task (maximum duration: 25 minutes)..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study startFeb 2020 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- 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
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, European Regional Development Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251104
- Sponsor's protocol ID
- SBPLY/19/180501/000181
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32690050
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04251104
- Acronym / sponsor ID
- SBPLY/19/180501/000181
- Conditions
- Emotion Regulation, Mood Induction, Autobiographical Memory, Ageing
- Keywords
- Images, personal relevance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, European Regional Development Fund
- Study start
- Feb 2020 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 31 Jan 2020 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Level of personal relevance of images | Experimental | Other: Images' personal relevance effectiveness in objective and subjective mood recoveryThis 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). |
| Age (young and older adults comparison) | Other | Other: Images' personal relevance effectiveness in objective and subjective mood recoveryTo 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Images' personal relevance effectiveness in objective and subjective mood recoveryAfter 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), Level of personal relevance of images |
Primary outcome
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.
Assessment of positive and negative affect during the experimental phase
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)
Left frontal (F3, F7, FC5) and right frontal (F4, F8, FC6) electrode pools will be formed by averaging the frequency distributions of these signals
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)
The mean magnitud of delta frequency band activity will be calculated for each participant during each event type (film and images).
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)
The mean magnitud of theta frequency band activity will be calculated for each participant during each event type (film and images).
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)
The mean magnitud of alpha frequency band activity will be calculated for each participant during each event type (film and images).
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)
The mean magnitud of beta frequency band activity will be calculated for each participant during each event type (film and images).
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).
Electrodermal activity (EDA) or skin conductance (SC)
Time frame: Skin conductance is registered during all the experimental task (maximum duration: 25 minutes).
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.
Heart rate variability (HRV)
Time frame: HRV is registered during all the experimental task (maximum duration: 25 minutes)..
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Derived from this study: PubMed 32690050Fernandez 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Images' personal relevance effectiveness in objective and subjective mood recovery in people with Emotion Regulation and Mood Induction, run by University of Castilla-La Mancha.
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 6 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04251104, which also lists 1 linked publication.
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 31 Jan 2020.