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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Other: OxIGen; Other: OxIGen: control version

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 7EF
      • MRC Cognition and Brain Sciences Unit
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7JX
      • Department of Psychiatry, University of Oxford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OxIGen program; Internet based intervention taking place over 4 weeks	Other: OxIGen; Internet-based intervention with 12 sessions over 4 weeks
Placebo Comparator: OxIGen: control version; A control version of the internet-based OxIGen intervention	Other: OxIGen: control version; A control version of the OxIGen internet-based intervention (i.e. identical but with putative active components removed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in score on Beck Depression Inventory - II	Baseline and post-intervention (4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Change on Prospective Imagery Test		Baseline and Post-Intervention (4 weeks)
Change on Behavioural Activation in Depression Scale		Baseline and Post-Intervention (4 weeks)
Change in IAPT Toolkit	Includes the GAD-7, PHQ-9 and Work and Social Adjustment Scale	Baseline and Post-Intervention (4 weeks)
Change on EuroQol-5D		Baseline and Post-Intervention (4 weeks)
Change in Neuroticism		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 Beck Anxiety Inventory		Baseline and Follow-Up (one month, three months, six months)
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 on IAPT Toolkit	Includes GAD-7, PHQ-9, Work and Social Adjustment Scale	Baseline and Follow-Up (one month, three months, six months)
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	Task adapted from Sharot et al. (2007, Nature)	Post-Intervention (4 weeks)

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Lupina Foundation
• Investigators: Principal Investigator: Emily A Holmes, D.Clin.Psy, PhD, University of Oxford

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 27, 2011
• First Submitted That Met QC Criteria: September 28, 2011
• First Posted (Estimate): September 29, 2011

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 8, 2014
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Depression; Internet; Cognitive Bias
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 11/SC/0278