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

Depression Clinical Trial

— OxIGen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443234
• Other study ID #: 11/SC/0278
• Status: Completed
• Phase: Phase 2
• First received: September 27, 2011
• Last updated: January 8, 2014
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2013
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• OxIGen
Internet-based intervention with 12 sessions over 4 weeks
• OxIGen: control version
A control version of the OxIGen internet-based intervention (i.e. identical but with putative active components removed)

Locations

Country	Name	City	State
United Kingdom	MRC Cognition and Brain Sciences Unit	Cambridge	Cambridgeshire
United Kingdom	Department of Psychiatry, University of Oxford	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Lupina Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in score on Beck Depression Inventory - II		Baseline and post-intervention (4 weeks)	No
Secondary	Change in score on Quick Inventory of Depressive Symptoms - Self Report		Baseline and post-intervention (4 weeks)	No
Secondary	Change in State-Trait Anxiety Inventory (Trait scale)		Baseline and Post-Intervention (4 weeks)	No
Secondary	Change on Beck Anxiety Inventory		Baseline and Post-Intervention (4 weeks)	No
Secondary	Change on Scrambled Sentences Task		Baseline and Post-Intervention (4 weeks)	No
Secondary	Change on Life Orientation Test - Revised		Baseline and Post-Intervention (4 weeks)	No
Secondary	Change on Prospective Imagery Test		Baseline and Post-Intervention (4 weeks)	No
Secondary	Change on Behavioural Activation in Depression Scale		Baseline and Post-Intervention (4 weeks)	No
Secondary	Change in IAPT Toolkit	Includes the GAD-7, PHQ-9 and Work and Social Adjustment Scale	Baseline and Post-Intervention (4 weeks)	No
Secondary	Change on EuroQol-5D		Baseline and Post-Intervention (4 weeks)	No
Secondary	Change in Neuroticism		Baseline and Post-Intervention (4 weeks)	No
Secondary	Change on Beck Depression Inventory - II		Baseline and Follow-Up (one month, three months, six months)	No
Secondary	Change on Quick Inventory of Depressive Symptoms - Self Report		Baseline and Follow-Up (one month, three months, six months)	No
Secondary	Change on State-Trait Anxiety Inventory (Trait scale)		Baseline and Follow-Up (one month, three months, six months)	No
Secondary	Change on Beck Anxiety Inventory		Baseline and Follow-Up (one month, three months, six months)	No
Secondary	Change on Life Orientation Test - Revised		Baseline and Follow-Up (one month, three months, six months)	No
Secondary	Change on Prospective Imagery Test		Baseline and Follow-Up (one month, three months, six months)	No
Secondary	Change on Behavioural Activation in Depression Scale		Baseline and Follow-Up (one month, three months, six months)	No
Secondary	Change on IAPT Toolkit	Includes GAD-7, PHQ-9, Work and Social Adjustment Scale	Baseline and Follow-Up (one month, three months, six months)	No
Secondary	Change on Euroqol-5D		Baseline and Follow-Up (one month, three months, six months)	No
Secondary	Change on Neuroticism		Baseline and Follow-Up (one month, three months, six months)	No
Secondary	Image Generation Task	Task adapted from Sharot et al. (2007, Nature)	Post-Intervention (4 weeks)	No