- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05276583
Does Depression Impact Our Memory for Rewarding Experiences
The Role of Memory Consolidation in Negative Memory Biases in Affective Disorders
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Sleep, at its basis, is known to be an important factor for mental health outcomes, yet the contribution of sleep dependent memory consolidation to those outcomes is poorly understood. In depression, learning and memory consolidation is often impaired and this may have long-term consequences that are driven by poor sleep, for those diagnosed with a depressive disorder. Indeed, depressed patients also have impairments in sleep specific physiological activity, which are crucial for efficient memory consolidation whereby memories are reactivated for long-term storage (e.g., slow-wave-sleep). This may contribute to depression symptoms such as anhedonia, a loss of interest in pleasurable activities, which in one study has been related to reduced ability to remember rewarding experiences and reduced activity in reward-related brain networks (e.g., ventral striatum). In order to understand the complex relationship between, sleep, depression and reward it is first necessary to establish a reliable effect size for the relationship between depression and reward-related memory consolidation. Indeed, in recent years it has been found that many published studies lack statistical power to reliably establish robust effect sizes due to small sample size. Therefore, in this experiment the investigators will examine the impact of depression on reward related memory consolidation with a large sample to yield a reliable estimate of the effect size. All participants will undergo the motivated learning task and will have their memory tested for reward related images before and after a 24-hour retention interval. Based on previous research the investigators predict the following:
H1: Memory for images associated with high reward will be greater compared to memory for images associated with low reward.
H3: Healthy controls will have higher memory performance compared to depressed patients.
H2: The magnitude of the benefit for high reward on memory will be greater for healthy controls compared to depressed patients.
Sample Size:
The investigators determined the sample size by performing a data simulation. They achieved this by simulating effects which are in line with our hypotheses using a linear mixed effects model. That data simulation indicated that 400 participants in total would be required to detect the effects of interest with 95% power. If participants have missing data, then that data will be recollected until the desired sample is achieved.
Procedure
All participants will complete the following procedure online via their choice of browser and computer over two sessions. In the first session participants will first sign the consent form then complete the Becks Depression Inventory (BDI) to determine their mental health status. Once complete participants will provide their demographic information (age, sex, gender, education, etc.), complete the Alcohol Use Disorders Identification Test (AUDIT), the Generalised Anxiety Disorder - 7 (GAD-7), Snaith-Hamilton Pleasure Scale (SHAPS), Stanford Sleepiness Scale (SSS) and lastly the Psychomotor Vigilance Task (PVT). Then participants begin the first part of the Motivated Learning Task, the study phase. After a 24-hour retention interval, participants complete the SSS and PVT a second time then complete the test phase of the Motivated Learning Task. Following the conclusion of the test phase, participants are debriefed.
Analysis Plan:
The investigators will use a linear mixed effects models with maximal effects structures to answer the hypotheses. In this case the maximal structure will be used as not including all slopes, intercepts, and correlation structures can increase false positive rates. However, it is also possible that such a model may not converge due to this. Therefore, if necessary, parameters will be removed iteratively starting with correlations of random slopes and then the random slopes themselves.
To examine the hypotheses (H1, H2 and H3) the following linear mixed effects model will be used and reduced accordingly for the reasons specified above:
d' ~ reward * depression + (reward * depression| participant)
Although there will be a positive effect of reward on memory sensitivity in both depressed participants and healthy controls, the investigators expect that this effect will be more pronounced in the latter.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: David P Morgan, PhD
- Numéro de téléphone: 6527 0621 1703
- E-mail: david.morgan@zi-mannheim.de
Lieux d'étude
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BW
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Mannheim, BW, Allemagne, 68159
- Central Institute of Mental Health
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Contact:
- David P Morgan, PhD
- E-mail: david.morgan@zi-mannheim.de
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Chercheur principal:
- David P Morgan, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion criteria
- Prolific approval rating of at least 95% and have participated in at least 10 studies on Prolific.
- Country of residence: United Kingdom
- Aged between 20-45
- Education level: At least A-levels or equivalent
- Participants must use a computer or laptop to participate.
- Participants must not have participated in the study conducted to validate the images used in this experiment and in the experiment from our previous preregistrations.
- Participants must not have participated in the previous studies which used the stimuli for this task.
Exclusion criteria
- Participants who incorrectly answer the practice trials and/or the questions of either the learning or test phases of the Motivated Learning Task. (For every question, they can try twice. Only if they get it wrong twice for a given practice phase/question they are excluded.)
- Participants with reaction times below 150ms in more than 20 % of the flanker task and/or the PVT. (These are considered implausibly fast reaction times that indicate that participants did not participate in the task the way it is intended, e.g., random key presses or clicking)
- who have 20% or more lapses (reaction times above 1000 ms) on the PVT.
- Participants who incorrectly respond on > 50% of the flanker task, indicating they did not pay attention to the task.
- Participants with a d' of 0 and below, indicating chance or worse than chance performance.
- Participants who do not complete both parts of the experiment.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Patients with depression like symptoms
Participants in this condition must indicate that they are currently suffering from a mental health illness and score at least 20 on the Becks Depression Inventory.
These participants will undergo the motivate learning task and will study images associated with high and low rewards.
After 24-hours participants will be tested on their memory for those images.
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The Motivated Learning Task is split into two parts, the learning phase, and the test phase.
During the learning phase participants are presented with 72 landscape images (targets) which they must memorise.
Each image which participants are shown is associated with a reward amount.
During the test phase participants are shown the 72 images they saw during the learning phase, known as targets, intermixed with 72 new images they did not see during the learning phase, known as lures.
Participants must decide whether the image is "old" (i.e., they saw it during the learning phase) or "new" (i.e. they did not see it during the learning phase).
After they have made their old/new decision, participants rate their confidence in their decision on a 3-point scale (i.e., guess, sure, very sure).
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Healthy controls without depression like symptoms
Participants in this condition must indicate that they do not currently suffer from a mental health condition and score less than 20 on the Becks depression inventory.
These participants will also undergo the motivate learning task and will study images associated with high and low rewards.
After 24-hours participants will be tested on their memory for those images.
|
The Motivated Learning Task is split into two parts, the learning phase, and the test phase.
During the learning phase participants are presented with 72 landscape images (targets) which they must memorise.
Each image which participants are shown is associated with a reward amount.
During the test phase participants are shown the 72 images they saw during the learning phase, known as targets, intermixed with 72 new images they did not see during the learning phase, known as lures.
Participants must decide whether the image is "old" (i.e., they saw it during the learning phase) or "new" (i.e. they did not see it during the learning phase).
After they have made their old/new decision, participants rate their confidence in their decision on a 3-point scale (i.e., guess, sure, very sure).
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Discriminability, d'
Délai: immediately after the procedure
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Discriminability refers to the ability of a participant to distinguish between targets, i.e., images that were presented to them, and lures, i.e., images that were not shown to them. This is calculated using the following formula: z("hit rate" )-z("false alarm rate") and will be calculated for each reward category. |
immediately after the procedure
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Hit Rate
Délai: immediately after the procedure
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The hit rate refers to the number of hits (i.e., correct "old" responses to target images) divided by the number of target trials.
The hit rate will be calculated for every reward category.
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immediately after the procedure
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False Alarm Rate
Délai: immediately after the procedure
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The false alarm rate, the number of false alarms (i.e., incorrect "old" responses to lure images)/the number of lure trials.
The false alarm rate will be calculated for every reward category
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immediately after the procedure
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Criterion, C
Délai: immediately after the procedure
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Criterion refers to a participants willingness to say "old" irrespective of whether or not they actually saw the image. Criterion is calculate using the following formula: (- z("hit rate" )+ z("false alarm rate" )) / 2 and will be calculated for every reward category. |
immediately after the procedure
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Becks Depression Inventory BDI
Délai: Assessed at the beginning of the experiment once
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The BDI is a 21-item self-report measure of depression symptoms and will be used to distinguish between groups who are not depressed from those who may suffer from depression.
Participants answer with one of four responses per item which is scored from 0 - 3. Scores on the BDI range from 1 - 40 with higher scores being more indicative of severe depression symptoms.
Participants who score > 19 will be classified as depressed.
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Assessed at the beginning of the experiment once
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Generalised Anxiety Disorder - 7 GAD
Délai: Assessed during the first part of the experiment after the BDI.
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The GAD-7 is a 7-item self-report measure of anxiety, with scores ranging from 0-21, where each item is assigned a score ranging from 0-3.
Higher scores are indicative of worse anxiety related symptoms.
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Assessed during the first part of the experiment after the BDI.
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Snaith-Hamilton Pleasure Scale (SHAPS)
Délai: Assessed during the first part of the experiment after the GAD.
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The SHAPS is a 14-item self-report scale measuring anhedonia.
Participants respond with Definitely Agree, Agree, Disagree, and Strongly Disagree to each item, where disagree responses receive a score of 1 and remaining responses receive a score of 0. Scores range from 0 - 14 with higher scores indicating greater levels of anhedonia.
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Assessed during the first part of the experiment after the GAD.
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Stanford Sleepiness Scale (SSS)
Délai: Assessed during the first and second parts of the experiment, that is before the study phase and before the test phase
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The SSS is a measure of sleepiness that will allow us to rule out whether differences in memory performance between sleep and wake conditions are due to tiredness at learning and test phases.
Participants will indicate their sleepiness on a 7-point scale ranging from from 1 = active, vital, alert or wide awake to 7 = no longer fighting sleepiness, about to fall asleep, dream-like thoughts..
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Assessed during the first and second parts of the experiment, that is before the study phase and before the test phase
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Psychomotor Vigilance Task (PVT)
Délai: Assessed during the first and second parts of the experiment, that is before the study phase and before the test phase
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Differences in vigilance between healthy and patient conditions will be examined using the 5-minute version of the PVT.
Participants are required to press the spacebar whenever they see a timer counting upwards.
Vigilance will be assessed by comparing reaction times between session 1 and session 2.
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Assessed during the first and second parts of the experiment, that is before the study phase and before the test phase
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Alcohol Use Disorders Identification Test, AUDIT
Délai: The AUDIT is collected during the first part of the experiment before the BDI
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Participants will complete the 10-item self-report version of the AUDIT.
In this scale participants indicate their level of alcohol consumption and how often it has impacted their life.
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The AUDIT is collected during the first part of the experiment before the BDI
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: David P Morgan, PhD, Central Institute of Mental Health
Publications et liens utiles
Publications générales
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
- Roach GD, Dawson D, Lamond N. Can a shorter psychomotor vigilance task be used as a reasonable substitute for the ten-minute psychomotor vigilance task? Chronobiol Int. 2006;23(6):1379-87. doi: 10.1080/07420520601067931.
- Hoddes E, Zarcone V, Smythe H, Phillips R, Dement WC. Quantification of sleepiness: a new approach. Psychophysiology. 1973 Jul;10(4):431-6. doi: 10.1111/j.1469-8986.1973.tb00801.x. No abstract available.
- Adcock RA, Thangavel A, Whitfield-Gabrieli S, Knutson B, Gabrieli JD. Reward-motivated learning: mesolimbic activation precedes memory formation. Neuron. 2006 May 4;50(3):507-17. doi: 10.1016/j.neuron.2006.03.036.
- Snaith P. Anhedonia: a neglected symptom of psychopathology. Psychol Med. 1993 Nov;23(4):957-66. doi: 10.1017/s0033291700026428.
- Dillon DG, Dobbins IG, Pizzagalli DA. Weak reward source memory in depression reflects blunted activation of VTA/SN and parahippocampus. Soc Cogn Affect Neurosci. 2014 Oct;9(10):1576-83. doi: 10.1093/scan/nst155. Epub 2013 Sep 26.
- Button KS, Ioannidis JP, Mokrysz C, Nosek BA, Flint J, Robinson ES, Munafo MR. Power failure: why small sample size undermines the reliability of neuroscience. Nat Rev Neurosci. 2013 May;14(5):365-76. doi: 10.1038/nrn3475. Epub 2013 Apr 10. Erratum In: Nat Rev Neurosci. 2013 Jun;14(6):451.
- Barr DJ, Levy R, Scheepers C, Tily HJ. Random effects structure for confirmatory hypothesis testing: Keep it maximal. J Mem Lang. 2013 Apr;68(3):10.1016/j.jml.2012.11.001. doi: 10.1016/j.jml.2012.11.001.
- Bates D, Kliegl R, Vasishth S, Baayen H. Parsimonious mixed models. arXiv preprint arXiv:1506.04967. 2015.
- Beck AT, Steer RA, Brown GK. Beck depression inventory (BDI-II). Pearson; 1996.
- Heisig JP, Schaeffer M. Why you should always include a random slope for the lower-level variable involved in a cross-level interaction. European Sociological Review. 2019 ;35(2): 258-79.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DMEMxp
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
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