Dynamic Learning in Depression

NCT02913898 | Completed

• 1 other identifier: Dynamic Learning in Depression
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

learning

Outcome Measures

Primary Outcomes (1)

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

  Standard questionnaire measure of depressive symptoms

  change between baseline and week 6

Secondary Outcomes (5)

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

  change between baseline and week 2

• Montgomery Asberg Depression Rating Scale

  change from baseline to week 2 and 6

• Learning parameters from information bias assessment task

  baseline to weeks 2 and 6

• Salivary cortisol concentration

  baseline to weeks 2 and 6

• Learning parameters derived from pupillometry data

  baseline to weeks 2 and 6

Other Outcomes (5)

• Speilberger State and Trait Anxiety Inventory

  Baseline to weeks 2 and 6

• Depressive Attributes Questionnaire

  baseline to weeks 2 and 6

• Rumination Response Scale

  baseline to weeks 2 and 6

Study Arms (2)

IBLT (information bias learning task)

EXPERIMENTAL

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

Behavioral: IBLT

IBLT control

PLACEBO COMPARATOR

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

Interventions

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 (information bias learning task)

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

IBLT control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Dept of Psychiatry, University of Oxford

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Michael Browning, MB.BS

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 26, 2016
• Study Start: November 1, 2016
• Primary Completion: June 3, 2020
• Study Completion: June 3, 2020
• Last Updated: June 16, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)