跳至主要内容
临床试验/NCT04251104
NCT04251104Unknown不适用

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

University of Castilla-La Mancha0 个研究点目标入组 240 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
240
主要终点
EEG power in alpha band

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

盲法说明

Psychologists responsible for participant recruitment will be blinded to the information about the group allocation. Due to the nature of the intervention neither participants nor psychologists responsible for the experimental phase can be blinded for the allocation, but the psychologist will be trained to decrease as much as possible her influence on the participants. For this, the psychologist will be provided with clear steps and norms to follow during the experimental intervention.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

EEG power in alpha band

时间窗: 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).

Hemispheric frontal asymmetry in EEG activity

时间窗: 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 theta band

时间窗: 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).

Electrodermal activity (EDA) or skin conductance (SC)

时间窗: 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.

Mood state measures: Positive and Negative Affect Schedule (PANAS)

时间窗: 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

EEG power in beta band

时间窗: 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

时间窗: 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).

EEG power in delta band

时间窗: 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).

Heart rate variability (HRV)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Sponsor

相似试验