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Dynamic Learning in Depression

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ClinicalTrials.gov Identifier: NCT02913898
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: IBLT Behavioral: IBLT control Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dynamic Learning in Depression
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913898


Contacts
Contact: Michael Browning, MB.BS +44 (0)1865 226395 michael.browning@psych.ox.ac.uk

Locations
United Kingdom
Dept of Psychiatry, University of Oxford Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Contact: Michael Browning, MB.BS    +44 (0)1865 6183161    michael.browning@psych.ox.ac.uk   
Principal Investigator: Michael Browning, MB.BS         
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Michael Browning, MB.BS University of Oxford

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02913898     History of Changes
Other Study ID Numbers: Dynamic Learning in Depression
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data will be shared with researchers who contact the PI after study completion.

Keywords provided by University of Oxford:
learning

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders