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Dynamic Learning in Depression

Dynamic Learning in Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02913898
Enrollment
120
Registered
2016-09-26
Start date
2016-11-01
Completion date
2020-06-03
Last updated
2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

learning

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALIBLT

Information bias learning task-- a computer based task in which positive information is more useful when learning how best to complete it

BEHAVIORALIBLT control

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

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Quick Inventory of Depressive Symptoms (self report, 16 item)change between baseline and week 6Standard questionnaire measure of depressive symptoms

Secondary

MeasureTime frameDescription
Quick Inventory of Depressive Symptoms (self report, 16 item)change between baseline and week 2standard questionnaire measure of depressive symptoms
Montgomery Asberg Depression Rating Scalechange from baseline to week 2 and 6Standard clinical rating scale for depression
Learning parameters from information bias assessment taskbaseline to weeks 2 and 6Derived parameters from a computer based learning task (tests process presumed to be altered by IBLT-- information bias learning task-- intervention)
Salivary cortisol concentrationbaseline to weeks 2 and 6Samples collected on waking
Learning parameters derived from pupillometry databaseline to weeks 2 and 6Parameters are derived from regression of pupil size data collected during the information bias assessment task

Other

MeasureTime frameDescription
Rumination Response Scalebaseline to weeks 2 and 6Questionnaire assessing tendency to ruminate
Snaith-Hamilton Pleasures ScaleBaseline to weeks 2 and 6Questionnaire assessing anhedonia
Speilberger State and Trait Anxiety InventoryBaseline to weeks 2 and 6standard questionnaire measure of state and trait anxiety
Depressive Attributes Questionnairebaseline to weeks 2 and 6Questionnaire assessing attribution bias in depression
Accuracy and reaction time during computerised cognitive tasksbaseline to weeks 2 and 6Scores are derived from computer based tasks assessing emotional perception and learning

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026