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Completed

NCT Number: NCT02913898

Dynamic Learning in Depression

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Psychiatry, University of Oxford

Oxford, Oxfordshire, OX3 7JX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IBLT

Behavioral

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

IBLT control

Behavioral

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

Primary outcomes

  1. Quick Inventory of Depressive Symptoms (self report, 16 item)

    Time frame: change between baseline and week 6

    Standard questionnaire measure of depressive symptoms

Secondary outcomes

  1. Quick Inventory of Depressive Symptoms (self report, 16 item)

    Time frame: change between baseline and week 2

    standard questionnaire measure of depressive symptoms

  2. Montgomery Asberg Depression Rating Scale

    Time frame: change from baseline to week 2 and 6

    Standard clinical rating scale for depression

  3. Learning parameters from information bias assessment task

    Time frame: 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)

  4. Salivary cortisol concentration

    Time frame: baseline to weeks 2 and 6

    Samples collected on waking

  5. Learning parameters derived from pupillometry data

    Time frame: baseline to weeks 2 and 6

    Parameters are derived from regression of pupil size data collected during the information bias assessment task

Other outcomes

  1. Speilberger State and Trait Anxiety Inventory

    Time frame: Baseline to weeks 2 and 6

    standard questionnaire measure of state and trait anxiety

  2. Depressive Attributes Questionnaire

    Time frame: baseline to weeks 2 and 6

    Questionnaire assessing attribution bias in depression

  3. Rumination Response Scale

    Time frame: baseline to weeks 2 and 6

    Questionnaire assessing tendency to ruminate

  4. Snaith-Hamilton Pleasures Scale

    Time frame: Baseline to weeks 2 and 6

    Questionnaire assessing anhedonia

  5. Accuracy and reaction time during computerised cognitive tasks

    Time frame: baseline to weeks 2 and 6

    Scores are derived from computer based tasks assessing emotional perception and learning

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2016
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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