DepressionNCT05276583
Does Depression Impact Our Memory for Rewarding Experiences
An observational study of Depression, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
When individuals experience depression, they may find that their brain does not work in the same way that they are used to. For example, sometimes the ability to remember things that happened during the day is not so good. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Motivated Learning Task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- May 2022to May 2022
- Phase
- Observational
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All participants will be recruited online using the online work-sourcing platform Prolific (www.prolific.com). Prolific has access to participant populations who are considered healthy and those who are suffering from mental health conditions. However the website is unable to determine whether participants have depressive symptoms or not, therefore the BDI will be administered to divide participants into healthy controls and those with depressive symptoms as described previously.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Central Institute of Mental Health
Mannheim, Baden-Wurttemberg, 68159
David P Morgan, PhD, david.morgan@zi-mannheim.de
David P Morgan, PhD
About this study
Official title: The Role of Memory Consolidation in Negative Memory Biases in Affective Disorders
When individuals experience depression, they may find that their brain does not work in the same way that they are used to. For example, sometimes the ability to remember things that happened during the day is not so good. This might specifically impact positive memories, for example remembering having fun at the ice cream shop with some friends. This is because when individuals are depressed they sometimes can not remember positive experiences as our brains do not have the chemicals needed to store those memories. In this experiment the investigators want to see if the ability to remember positive information is negatively impacted by depression. To do so, participants will look at some images that are related to winning high vs. low rewards. Next they are tested on their memory for those images. Participants will also be asked some questions about themselves and their mental health. The investigators expect that those who are experiencing depression will be less able to remember images related to higher rewards compared to those who are not experiencing depression.
Read the detailed description
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.
- Conditions
- Depression
- Being tested
- Motivated Learning Task
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivated Learning TaskBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Motivated Learning Task | |
| 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. Receives: Behavioral: Motivated Learning Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discriminability, d'
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.
Measured: immediately after the procedure
Secondary outcomes (3)
Hit Rate
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.
Measured: immediately after the procedure
False Alarm Rate
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
Measured: immediately after the procedure
Criterion, C
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.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study startMay 2022 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- David P Morgan, PhD, Principal investigator, Central Institute of Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276583
- Sponsor's protocol ID
- DMEMxp
- Status last verified
- Mar 2022
- First submitted
- 27 Dec 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the study has been published all of the anonymised individual participant data will be made available on the Open Science Framework (https://osf.io). The shared data will include all data that underlies the results reported in the publication and supplementary data that may not have been used but may be useful to other researchers. The data will be made available to any researcher who has access to the Open Science Framework and completes a data use agreement form and has IRB or ethical approval to carry out their proposed analyses.
Publications
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.
PubMed 16675403Hoddes 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.
PubMed 4719486Roach 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.
PubMed 17190720Snaith P. Anhedonia: a neglected symptom of psychopathology. Psychol Med. 1993 Nov;23(4):957-66. doi: 10.1017/s0033291700026428.
PubMed 8134519Spitzer 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.
PubMed 16717171Saunders 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.
PubMed 8329970Dillon 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.
PubMed 24078019Button 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.
PubMed 23571845Barr 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.
PubMed 24403724Bates 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Memory Consolidation in Negative Memory Biases in Affective Disorders
- ClinicalTrials.gov ID
- NCT05276583
- Acronym / sponsor ID
- DMEMxp
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- May 2022 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 11 Mar 2022 (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.
When individuals experience depression, they may find that their brain does not work in the same way that they are used to. For example, sometimes the ability to remember things that happened during the day is not so good. This might specifically impact positive memories, for example remembering having fun at the ice cream shop with some friends. This is because when individuals are depressed they sometimes can not remember positive experiences as our brains do not have the chemicals needed to store those memories. In this experiment the investigators want to see if the ability to remember positive information is negatively impacted by depression. To do so, participants will look at some images that are related to winning high vs. low rewards. Next they are tested on their memory for those images. Participants will also be asked some questions about themselves and their mental health. The investigators expect that those who are experiencing depression will be less able to remember images related to higher rewards compared to those who are not experiencing depression.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with depression like symptoms | – | Behavioral: Motivated Learning TaskParticipants 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. |
| Healthy controls without depression like symptoms | – | Behavioral: Motivated Learning TaskParticipants 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All participants will be recruited online using the online work-sourcing platform Prolific (www.prolific.com). Prolific has access to participant populations who are considered healthy and those who are suffering from mental health conditions. However the website is unable to determine whether participants have depressive symptoms or not, therefore the BDI will be administered to divide participants into healthy controls and those with depressive symptoms as described previously.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Motivated Learning TaskThe 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). | Behavioural | Healthy controls without depression like symptoms, Patients with depression like symptoms |
Primary outcome
Discriminability, d'
Time frame: immediately after the procedure
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.
3 secondary outcomes
Hit Rate
Time frame: immediately after the procedure
False Alarm Rate
Time frame: immediately after the procedure
Criterion, C
Time frame: immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Background: PubMed 16675403Adcock 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.
- Background: PubMed 4719486Hoddes 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.
- Background: PubMed 17190720Roach 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.
- Background: PubMed 8134519Snaith P. Anhedonia: a neglected symptom of psychopathology. Psychol Med. 1993 Nov;23(4):957-66. doi: 10.1017/s0033291700026428.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 8329970Saunders 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.
- Background: PubMed 24078019Dillon 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.
- Background: PubMed 23571845Button 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.
- Background: PubMed 24403724Barr 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.
- BackgroundBates D, Kliegl R, Vasishth S, Baayen H. Parsimonious mixed models. arXiv preprint arXiv:1506.04967. 2015.
- BackgroundBeck AT, Steer RA, Brown GK. Beck depression inventory (BDI-II). Pearson; 1996.
- BackgroundHeisig 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.
- Individual participant dataSharing planned: Yes. Once the study has been published all of the anonymised individual participant data will be made available on the Open Science Framework (https://osf.io). The shared data will include all data that underlies the results reported in the publication and supplementary data that may not have been used but may be useful to other researchers. The data will be made available to any researcher who has access to the Open Science Framework and completes a data use agreement form and has IRB or ethical approval to carry out their proposed analyses.
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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.
David P Morgan, PhD principal investigator
Central Institute of Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
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 7 inclusion and 6 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 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact David P Morgan, PhD (0621 1703 ext. 6527, david.morgan@zi-mannheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discriminability, d' (time frame: immediately after the procedure). 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 NCT05276583, which also lists 12 linked publications.
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 11 Mar 2022.