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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04251104
Other study ID # SBPLY/19/180501/000181
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2020
Est. completion date April 2020

Study information

Verified date January 2020
Source University of Castilla-La Mancha
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 240
Est. completion date April 2020
Est. primary completion date April 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
Images' personal relevance effectiveness in objective and subjective mood recovery
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of Castilla-La Mancha European Regional Development Fund, Ministerio de Economía y Competitividad, Spain

Outcome

Type Measure Description Time frame Safety issue
Primary Mood state measures: Positive and Negative Affect Schedule (PANAS) Assessment of positive and negative affect during the experimental phase 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.
Primary 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 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)
Primary 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). 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)
Primary 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). 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)
Primary 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). 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)
Primary 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). 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)
Primary 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). 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)
Primary 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. Skin conductance is registered during all the experimental task (maximum duration: 25 minutes).
Primary 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. HRV is registered during all the experimental task (maximum duration: 25 minutes)..
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