Dynamic Learning in Depression

Depression Clinical Trial

Official title:

Dynamic Learning in Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913898
• Other study ID #: Dynamic Learning in Depression
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: June 3, 2020

Study information

• Verified date: April 2019
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 3, 2020
• Est. primary completion date: June 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Dept of Psychiatry, University of Oxford	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Speilberger State and Trait Anxiety Inventory	standard questionnaire measure of state and trait anxiety	Baseline to weeks 2 and 6
Other	Depressive Attributes Questionnaire	Questionnaire assessing attribution bias in depression	baseline to weeks 2 and 6
Other	Rumination Response Scale	Questionnaire assessing tendency to ruminate	baseline to weeks 2 and 6
Other	Snaith-Hamilton Pleasures Scale	Questionnaire assessing anhedonia	Baseline to weeks 2 and 6
Other	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
Primary	Quick Inventory of Depressive Symptoms (self report, 16 item)	Standard questionnaire measure of depressive symptoms	change between baseline and week 6
Secondary	Quick Inventory of Depressive Symptoms (self report, 16 item)	standard questionnaire measure of depressive symptoms	change between baseline and week 2
Secondary	Montgomery Asberg Depression Rating Scale	Standard clinical rating scale for depression	change from baseline to week 2 and 6
Secondary	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
Secondary	Salivary cortisol concentration	Samples collected on waking	baseline to weeks 2 and 6
Secondary	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