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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: IBLT; Behavioral: IBLT control

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7JX
      • Dept of Psychiatry, University of Oxford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: IBLT; Information bias learning task-- a computer based task in which positive information is more useful when learning how best to complete it
Placebo Comparator: 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	Behavioral: IBLT 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Inventory of Depressive Symptoms (self report, 16 item)	Standard questionnaire measure of depressive symptoms	change between baseline and week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Inventory of Depressive Symptoms (self report, 16 item)	standard questionnaire measure of depressive symptoms	change between baseline and week 2
Montgomery Asberg Depression Rating Scale	Standard clinical rating scale for depression	change from baseline to week 2 and 6
Learning parameters from information bias assessment task	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	Samples collected on waking	baseline to weeks 2 and 6
Learning parameters derived from pupillometry data	Parameters are derived from regression of pupil size data collected during the information bias assessment task	baseline to weeks 2 and 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speilberger State and Trait Anxiety Inventory	standard questionnaire measure of state and trait anxiety	Baseline to weeks 2 and 6
Depressive Attributes Questionnaire	Questionnaire assessing attribution bias in depression	baseline to weeks 2 and 6
Rumination Response Scale	Questionnaire assessing tendency to ruminate	baseline to weeks 2 and 6
Snaith-Hamilton Pleasures Scale	Questionnaire assessing anhedonia	Baseline to weeks 2 and 6
Accuracy and reaction time during computerised cognitive tasks	Scores are derived from computer based tasks assessing emotional perception and learning	baseline to weeks 2 and 6

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Michael Browning, MB.BS, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): June 3, 2020
• Study Completion (Actual): June 3, 2020

Study Registration Dates

• First Submitted: September 22, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (Estimate): September 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 15, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: learning
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: Dynamic Learning in Depression

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data will be shared with researchers who contact the PI after study completion.