- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02913898
Dynamic Learning in Depression
15 juni 2020 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
120
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Oxfordshire
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Oxford, Oxfordshire, Storbritannien, OX3 7JX
- Dept of Psychiatry, University of Oxford
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 60 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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-jämförare: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Quick Inventory of Depressive Symptoms (self report, 16 item)
Tidsram: change between baseline and week 6
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Standard questionnaire measure of depressive symptoms
|
change between baseline and week 6
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Quick Inventory of Depressive Symptoms (self report, 16 item)
Tidsram: change between baseline and week 2
|
standard questionnaire measure of depressive symptoms
|
change between baseline and week 2
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Montgomery Asberg Depression Rating Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Speilberger State and Trait Anxiety Inventory
Tidsram: Baseline to weeks 2 and 6
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standard questionnaire measure of state and trait anxiety
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Baseline to weeks 2 and 6
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Depressive Attributes Questionnaire
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Michael Browning, MB.BS, University of Oxford
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 november 2016
Primärt slutförande (Faktisk)
3 juni 2020
Avslutad studie (Faktisk)
3 juni 2020
Studieregistreringsdatum
Först inskickad
22 september 2016
Först inskickad som uppfyllde QC-kriterierna
22 september 2016
Första postat (Uppskatta)
26 september 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 juni 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 juni 2020
Senast verifierad
1 april 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Dynamic Learning in Depression
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Anonymised data will be shared with researchers who contact the PI after study completion.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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