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

Phase 2

Completed

• Conditions: Depression
• Interventions: Other: OxIGen

• Registration Number: NCT01443234
• Lead Sponsor: University of Oxford

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-29
• Study Start: 2012-02
• Primary Completion: 2013-04
• Status Verified: 2013-06
• Study Completion: 2013-12
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OxIGen program	OxIGen	Internet based intervention taking place over 4 weeks
OxIGen: control version	OxIGen	A control version of the internet-based OxIGen intervention

Primary Outcome Measures

Name	Time	Method
Change in score on Beck Depression Inventory - II	Baseline and post-intervention (4 weeks)

Secondary Outcome Measures

Name	Time	Method
Change in Neuroticism	Baseline and Post-Intervention (4 weeks)
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 Follow-Up (one month, three months, six months)
Change on Scrambled Sentences Task	Baseline and Post-Intervention (4 weeks)
Change on Life Orientation Test - Revised	Baseline and Follow-Up (one month, three months, six months)
Change on Prospective Imagery Test	Baseline and Follow-Up (one month, three months, six months)
Change on Behavioural Activation in Depression Scale	Baseline and Follow-Up (one month, three months, six months)
Change in IAPT Toolkit	Baseline and Post-Intervention (4 weeks)	Includes the GAD-7, PHQ-9 and Work and Social Adjustment Scale
Change on EuroQol-5D	Baseline and Post-Intervention (4 weeks)
Change on Beck Depression Inventory - II	Baseline and Follow-Up (one month, three months, six months)
Change on Quick Inventory of Depressive Symptoms - Self Report	Baseline and Follow-Up (one month, three months, six months)
Change on State-Trait Anxiety Inventory (Trait scale)	Baseline and Follow-Up (one month, three months, six months)
Change on IAPT Toolkit	Baseline and Follow-Up (one month, three months, six months)	Includes GAD-7, PHQ-9, Work and Social Adjustment Scale
Change on Euroqol-5D	Baseline and Follow-Up (one month, three months, six months)
Change on Neuroticism	Baseline and Follow-Up (one month, three months, six months)
Image Generation Task	Post-Intervention (4 weeks)	Task adapted from Sharot et al. (2007, Nature)

Trial Locations

Locations (2)

Department of Psychiatry, University of Oxford; 🇬🇧 Oxford, Oxfordshire, United Kingdom

MRC Cognition and Brain Sciences Unit; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom