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Dynamic Learning in Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
IBLT
IBLT control
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring learning

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dept of Psychiatry, University of Oxford

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IBLT (information bias learning task)

IBLT control

Arm Description

Computerised task in which most information is provided by positive outcomes. Completed for 10 mins per day every day for 2 weeks.

Computerised task in which information is provided by both positive and negative outcomes. Completed 10 mins per day every day for 2 weeks

Outcomes

Primary Outcome Measures

Quick Inventory of Depressive Symptoms (self report, 16 item)
Standard questionnaire measure of depressive symptoms

Secondary Outcome Measures

Quick Inventory of Depressive Symptoms (self report, 16 item)
standard questionnaire measure of depressive symptoms
Montgomery Asberg Depression Rating Scale
Standard clinical rating scale for depression
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)
Salivary cortisol concentration
Samples collected on waking
Learning parameters derived from pupillometry data
Parameters are derived from regression of pupil size data collected during the information bias assessment task

Full Information

First Posted
September 22, 2016
Last Updated
June 15, 2020
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT02913898
Brief Title
Dynamic Learning in Depression
Official Title
Dynamic Learning in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
June 3, 2020 (Actual)
Study Completion Date
June 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
learning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBLT (information bias learning task)
Arm Type
Experimental
Arm Description
Computerised task in which most information is provided by positive outcomes. Completed for 10 mins per day every day for 2 weeks.
Arm Title
IBLT control
Arm Type
Placebo Comparator
Arm Description
Computerised task in which information is provided by both positive and negative outcomes. Completed 10 mins per day every day for 2 weeks
Intervention Type
Behavioral
Intervention Name(s)
IBLT
Intervention Description
Information bias learning task-- a computer based task in which positive information is more useful when learning how best to complete it
Intervention Type
Behavioral
Intervention Name(s)
IBLT control
Intervention Description
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 Measure Information:
Title
Quick Inventory of Depressive Symptoms (self report, 16 item)
Description
Standard questionnaire measure of depressive symptoms
Time Frame
change between baseline and week 6
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptoms (self report, 16 item)
Description
standard questionnaire measure of depressive symptoms
Time Frame
change between baseline and week 2
Title
Montgomery Asberg Depression Rating Scale
Description
Standard clinical rating scale for depression
Time Frame
change from baseline to week 2 and 6
Title
Learning parameters from information bias assessment task
Description
Derived parameters from a computer based learning task (tests process presumed to be altered by IBLT-- information bias learning task-- intervention)
Time Frame
baseline to weeks 2 and 6
Title
Salivary cortisol concentration
Description
Samples collected on waking
Time Frame
baseline to weeks 2 and 6
Title
Learning parameters derived from pupillometry data
Description
Parameters are derived from regression of pupil size data collected during the information bias assessment task
Time Frame
baseline to weeks 2 and 6
Other Pre-specified Outcome Measures:
Title
Speilberger State and Trait Anxiety Inventory
Description
standard questionnaire measure of state and trait anxiety
Time Frame
Baseline to weeks 2 and 6
Title
Depressive Attributes Questionnaire
Description
Questionnaire assessing attribution bias in depression
Time Frame
baseline to weeks 2 and 6
Title
Rumination Response Scale
Description
Questionnaire assessing tendency to ruminate
Time Frame
baseline to weeks 2 and 6
Title
Snaith-Hamilton Pleasures Scale
Description
Questionnaire assessing anhedonia
Time Frame
Baseline to weeks 2 and 6
Title
Accuracy and reaction time during computerised cognitive tasks
Description
Scores are derived from computer based tasks assessing emotional perception and learning
Time Frame
baseline to weeks 2 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Browning, MB.BS
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Psychiatry, University of Oxford
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7JX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised data will be shared with researchers who contact the PI after study completion.

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Dynamic Learning in Depression

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