OxIGen: Oxford Imagery Generation: Investigating the Effects of an Internet Based Computer Program in Depression

NCT01443234 | Completed Phase 2

• 1 other identifier: 11/SC/0278
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

This research study is designed to investigate the effects of an online computer program, called OxIGen (Oxford Imagery Generation), on thinking style and mood in depression. The OxIGen program will be delivered online over four weeks and with follow-up at one, three and six months. This will inform potential future development of this computerized task into an online intervention to modify negative thinking styles in depression.

Conditions

Depression

Keywords

Depression; Cognitive Bias; Internet

Outcome Measures

Primary Outcomes (1)

• Change in score on Beck Depression Inventory - II

  Baseline and post-intervention (4 weeks)

Secondary Outcomes (21)

• Change in score on Quick Inventory of Depressive Symptoms - Self Report

  Baseline and post-intervention (4 weeks)

• Change in State-Trait Anxiety Inventory (Trait scale)

  Baseline and Post-Intervention (4 weeks)

• Change on Beck Anxiety Inventory

  Baseline and Post-Intervention (4 weeks)

• Change on Scrambled Sentences Task

  Baseline and Post-Intervention (4 weeks)

• Change on Life Orientation Test - Revised

  Baseline and Post-Intervention (4 weeks)

Study Arms (2)

OxIGen program

EXPERIMENTAL

Internet based intervention taking place over 4 weeks

Other: OxIGen

OxIGen: control version

PLACEBO COMPARATOR

A control version of the internet-based OxIGen intervention

Other: OxIGen: control version

Interventions

OxIGen OTHER

Internet-based intervention with 12 sessions over 4 weeks

OxIGen program

OxIGen: control version OTHER

A control version of the OxIGen internet-based intervention (i.e. identical but with putative active components removed)

OxIGen: control version

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give consent to the study
• Male or Female, aged between 18 and 65 years
• Current Major Depressive Episode (assessed by semi-structured clinical interview)
• Access to internet in order to complete the online program
• Able to travel to research centre for assessment appointments
• Fluent in written and spoken English

You may not qualify if:

• Meets criteria for current psychotic disorder
• History of mania or hypomania as assessed by semi-structured clinical interview, or has elsewhere received a diagnosis of Bipolar disorder
• Antidepressant medication begun or changed in dosage during last month
• Meets criteria for current substance abuse disorder
• Involved in other current treatment trials
• Currently receiving psychological therapy

Sponsors & Collaborators

• University of Oxford: lead
• Lupina Foundation: collaborator

Study Sites (2)

MRC Cognition and Brain Sciences Unit

Cambridge, Cambridgeshire, CB2 7EF, United Kingdom

Location

Department of Psychiatry, University of Oxford

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Emily A Holmes, D.Clin.Psy, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: September 29, 2011
• Study Start: February 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 9, 2014

Record last verified: 2013-06

Locations

GB (2)