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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Other: OxIGen
* Other: OxIGen: control version


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Cognitive Bias, Internet