Dynamic Learning in Depression
15. juni 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
120
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Oxfordshire
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Oxford, Oxfordshire, Det Forenede Kongerige, OX3 7JX
- Dept of Psychiatry, University of Oxford
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Information bias learning task-- a computer based task in which positive information is more useful when learning how best to complete it
|
|
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
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quick Inventory of Depressive Symptoms (self report, 16 item)
Tidsramme: change between baseline and week 6
|
Standard questionnaire measure of depressive symptoms
|
change between baseline and week 6
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quick Inventory of Depressive Symptoms (self report, 16 item)
Tidsramme: change between baseline and week 2
|
standard questionnaire measure of depressive symptoms
|
change between baseline and week 2
|
|
Montgomery Asberg Depression Rating Scale
Tidsramme: change from baseline to week 2 and 6
|
Standard clinical rating scale for depression
|
change from baseline to week 2 and 6
|
|
Learning parameters from information bias assessment task
Tidsramme: baseline to weeks 2 and 6
|
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
|
|
Salivary cortisol concentration
Tidsramme: baseline to weeks 2 and 6
|
Samples collected on waking
|
baseline to weeks 2 and 6
|
|
Learning parameters derived from pupillometry data
Tidsramme: baseline to weeks 2 and 6
|
Parameters are derived from regression of pupil size data collected during the information bias assessment task
|
baseline to weeks 2 and 6
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Speilberger State and Trait Anxiety Inventory
Tidsramme: Baseline to weeks 2 and 6
|
standard questionnaire measure of state and trait anxiety
|
Baseline to weeks 2 and 6
|
|
Depressive Attributes Questionnaire
Tidsramme: baseline to weeks 2 and 6
|
Questionnaire assessing attribution bias in depression
|
baseline to weeks 2 and 6
|
|
Rumination Response Scale
Tidsramme: baseline to weeks 2 and 6
|
Questionnaire assessing tendency to ruminate
|
baseline to weeks 2 and 6
|
|
Snaith-Hamilton Pleasures Scale
Tidsramme: Baseline to weeks 2 and 6
|
Questionnaire assessing anhedonia
|
Baseline to weeks 2 and 6
|
|
Accuracy and reaction time during computerised cognitive tasks
Tidsramme: baseline to weeks 2 and 6
|
Scores are derived from computer based tasks assessing emotional perception and learning
|
baseline to weeks 2 and 6
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Michael Browning, MB.BS, University of Oxford
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2016
Primær færdiggørelse (Faktiske)
3. juni 2020
Studieafslutning (Faktiske)
3. juni 2020
Datoer for studieregistrering
Først indsendt
22. september 2016
Først indsendt, der opfyldte QC-kriterier
22. september 2016
Først opslået (Skøn)
26. september 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juni 2020
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Dynamic Learning in Depression
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Anonymised data will be shared with researchers who contact the PI after study completion.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .