- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02913898
Dynamic Learning in Depression
15. Juni 2020 aktualisiert von: University of Oxford
This study will assess learning bias (the tendency to learn more from negative relative to positive outcomes) at baseline in 3 groups of participants (currently depressed, previously depressed and never depressed).
It will then try to modify this bias using a simple computerised training task completed at home daily for 2 weeks.
Outcome measures include symptoms of depression, cognitive measures (i.e.
accuracy and reaction time during completion of tasks), pupillometry measures and salivary cortisol.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Depressed patients tend to focus on negative, at the expense of positive, events.
This bias of attention is thought to be one factor which causes some people to be at higher risk of developing depression.
One reason depressed people might pay more attention to negative events is that they think those events are more useful to them when they learn about the future.
In this study the investigators will compare the learning styles (i.e.
whether participants focus more on negative or positive information when learning about the future), cognitive biases and salivary cortisol levels (the levels of the hormone cortisol can be measured in the saliva and is known to be raised in those at risk of depression) of currently depressed (N=40), previously depressed (N=40) and never depressed (N=40) participants.
The study will then randomly assign participants to complete one of two version of a learning task daily over two weeks.
One version of the task will be designed to encourage an optimistic learning style, whereas the other will encourage neither an optimistic nor pessimistic learning style.
The study will then retest participants' learning styles, cognitive biases, salivary cortisol and mood (using questionnaire measures) after completion of the task and again after 1 month.
Study activities for participants will be: Screening visit (1 hours), baseline test visit (2 hours), task completion at home (10 mins per day for 2 weeks), test visit 2 (2 hours, completed 2 weeks after baseline visit) and test visit 3 (2 hours, completed 1 month after test visit 2).
Participants will be asked to collect saliva samples, to measure cortisol, immediately after they wake up on the 3 testing days.
Note that testing sessions involve pupillometry (measurement of area of pupil of the eye).
This is done using a specialised camera pointed at the eye and is not invasive.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
120
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Oxfordshire
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Oxford, Oxfordshire, Vereinigtes Königreich, OX3 7JX
- Dept of Psychiatry, University of Oxford
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 60 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 to 60 years.
- Fluent in English.
- Not currently taking any psychoactive medications (except hormone contraceptives).
- Currently meets SCID (Structured Clinical Interview for Diagnosis:DSMV) criteria for MDD--Major Depressive Disorder-- (currently depressed group only).
- Meets SCID criteria for 2 or more previous episodes of MDD, has been in remission for at least 3 months (previously depressed group only).
- No previous or current axis I diagnosis (control group only).
Exclusion Criteria:
- Previous or current diagnosis of bipolar disorder or psychotic illness.
- Previous or current anxiety disorder (control group only, anxiety disorder is permitted in current and previously depressed group as long as primary diagnosis of MDD (current or previous) is present).
- Significant suicidal ideation.
- Use of drug of abuse within the last 3 months.
- Receiving treatment (either pharmacological or psychological) for psychiatric condition.
- Medical or surgical treatment which prevents dilation/constriction of pupil.
- Prior experience of the tasks used in the study.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: IBLT (information bias learning task)
Computerised task in which most information is provided by positive outcomes.
Completed for 10 mins per day every day for 2 weeks.
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Information bias learning task-- a computer based task in which positive information is more useful when learning how best to complete it
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Placebo-Komparator: IBLT control
Computerised task in which information is provided by both positive and negative outcomes.
Completed 10 mins per day every day for 2 weeks
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A control version of the IBLT task-- a computer based task in which both positive and negative information is useful when learning how to complete it
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Quick Inventory of Depressive Symptoms (self report, 16 item)
Zeitfenster: change between baseline and week 6
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Standard questionnaire measure of depressive symptoms
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change between baseline and week 6
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Quick Inventory of Depressive Symptoms (self report, 16 item)
Zeitfenster: change between baseline and week 2
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standard questionnaire measure of depressive symptoms
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change between baseline and week 2
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Montgomery Asberg Depression Rating Scale
Zeitfenster: change from baseline to week 2 and 6
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Standard clinical rating scale for depression
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change from baseline to week 2 and 6
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Learning parameters from information bias assessment task
Zeitfenster: baseline to weeks 2 and 6
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Derived parameters from a computer based learning task (tests process presumed to be altered by IBLT-- information bias learning task-- intervention)
|
baseline to weeks 2 and 6
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Salivary cortisol concentration
Zeitfenster: baseline to weeks 2 and 6
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Samples collected on waking
|
baseline to weeks 2 and 6
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Learning parameters derived from pupillometry data
Zeitfenster: baseline to weeks 2 and 6
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Parameters are derived from regression of pupil size data collected during the information bias assessment task
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baseline to weeks 2 and 6
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Speilberger State and Trait Anxiety Inventory
Zeitfenster: Baseline to weeks 2 and 6
|
standard questionnaire measure of state and trait anxiety
|
Baseline to weeks 2 and 6
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Depressive Attributes Questionnaire
Zeitfenster: baseline to weeks 2 and 6
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Questionnaire assessing attribution bias in depression
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baseline to weeks 2 and 6
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Rumination Response Scale
Zeitfenster: baseline to weeks 2 and 6
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Questionnaire assessing tendency to ruminate
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baseline to weeks 2 and 6
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Snaith-Hamilton Pleasures Scale
Zeitfenster: Baseline to weeks 2 and 6
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Questionnaire assessing anhedonia
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Baseline to weeks 2 and 6
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Accuracy and reaction time during computerised cognitive tasks
Zeitfenster: baseline to weeks 2 and 6
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Scores are derived from computer based tasks assessing emotional perception and learning
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baseline to weeks 2 and 6
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Michael Browning, MB.BS, University of Oxford
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. November 2016
Primärer Abschluss (Tatsächlich)
3. Juni 2020
Studienabschluss (Tatsächlich)
3. Juni 2020
Studienanmeldedaten
Zuerst eingereicht
22. September 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. September 2016
Zuerst gepostet (Schätzen)
26. September 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
16. Juni 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
15. Juni 2020
Zuletzt verifiziert
1. April 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Dynamic Learning in Depression
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
Anonymised data will be shared with researchers who contact the PI after study completion.
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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