Clinical trial NCT01443234: OxIGen: Oxford Imagery Generation: Investigating the Effects of an Internet Based Computer Program in Depression
Official title: OxIGen: Oxford Imagery Generation: Investigating the Effects of an Internet Based Computer Program in Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: Depression
Cognitive Bias
Internet
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Lupina Foundation
First posted: 2011-09-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in score on Beck Depression Inventory - II
timeFrame: Baseline and post-intervention (4 weeks)
Secondary outcomes:
measure: Change in score on Quick Inventory of Depressive Symptoms - Self Report
timeFrame: Baseline and post-intervention (4 weeks)
measure: Change in State-Trait Anxiety Inventory (Trait scale)
timeFrame: Baseline and Post-Intervention (4 weeks)
measure: Change on Beck Anxiety Inventory
timeFrame: Baseline and Post-Intervention (4 weeks)
measure: Change on Scrambled Sentences Task
timeFrame: Baseline and Post-Intervention (4 weeks)
measure: Change on Life Orientation Test - Revised
timeFrame: Baseline and Post-Intervention (4 weeks)
measure: Change on Prospective Imagery Test
timeFrame: Baseline and Post-Intervention (4 weeks)
measure: Change on Behavioural Activation in Depression Scale
timeFrame: Baseline and Post-Intervention (4 weeks)
measure: Change in IAPT Toolkit
timeFrame: Baseline and Post-Intervention (4 weeks)
measure: Change on EuroQol-5D
timeFrame: Baseline and Post-Intervention (4 weeks)
measure: Change in Neuroticism
timeFrame: Baseline and Post-Intervention (4 weeks)
measure: Change on Beck Depression Inventory - II
timeFrame: Baseline and Follow-Up (one month, three months, six months)
measure: Change on Quick Inventory of Depressive Symptoms - Self Report
timeFrame: Baseline and Follow-Up (one month, three months, six months)
measure: Change on State-Trait Anxiety Inventory (Trait scale)
timeFrame: Baseline and Follow-Up (one month, three months, six months)
measure: Change on Beck Anxiety Inventory
timeFrame: Baseline and Follow-Up (one month, three months, six months)
measure: Change on Life Orientation Test - Revised
timeFrame: Baseline and Follow-Up (one month, three months, six months)
measure: Change on Prospective Imagery Test
timeFrame: Baseline and Follow-Up (one month, three months, six months)
measure: Change on Behavioural Activation in Depression Scale
timeFrame: Baseline and Follow-Up (one month, three months, six months)
measure: Change on IAPT Toolkit
timeFrame: Baseline and Follow-Up (one month, three months, six months)
measure: Change on Euroqol-5D
timeFrame: Baseline and Follow-Up (one month, three months, six months)
measure: Change on Neuroticism
timeFrame: Baseline and Follow-Up (one month, three months, six months)
measure: Image Generation Task
timeFrame: Post-Intervention (4 weeks)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: MRC Cognition and Brain Sciences Unit
state: Cambridgeshire
city: Oxford
country: United Kingdom
facility: Department of Psychiatry, University of Oxford
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Emily A Holmes, D.Clin.Psy, PhD
role: PRINCIPAL_INVESTIGATOR
References: