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Completed

NCT Number: NCT01443234

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MRC Cognition and Brain Sciences Unit, Cambridge, Cambridgeshire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OxIGen

Other

Internet-based intervention with 12 sessions over 4 weeks

OxIGen: control version

Other

A control version of the OxIGen internet-based intervention (i.e. identical but with putative active components removed)

Primary outcomes

  1. Change in score on Beck Depression Inventory - II

    Time frame: Baseline and post-intervention (4 weeks)

Secondary outcomes

  1. Change in score on Quick Inventory of Depressive Symptoms - Self Report

    Time frame: Baseline and post-intervention (4 weeks)

  2. Change in State-Trait Anxiety Inventory (Trait scale)

    Time frame: Baseline and Post-Intervention (4 weeks)

  3. Change on Beck Anxiety Inventory

    Time frame: Baseline and Post-Intervention (4 weeks)

  4. Change on Scrambled Sentences Task

    Time frame: Baseline and Post-Intervention (4 weeks)

  5. Change on Life Orientation Test - Revised

    Time frame: Baseline and Post-Intervention (4 weeks)

  6. Change on Prospective Imagery Test

    Time frame: Baseline and Post-Intervention (4 weeks)

  7. Change on Behavioural Activation in Depression Scale

    Time frame: Baseline and Post-Intervention (4 weeks)

  8. Change in IAPT Toolkit

    Time frame: Baseline and Post-Intervention (4 weeks)

    Includes the GAD-7, PHQ-9 and Work and Social Adjustment Scale

  9. Change on EuroQol-5D

    Time frame: Baseline and Post-Intervention (4 weeks)

  10. Change in Neuroticism

    Time frame: Baseline and Post-Intervention (4 weeks)

  11. Change on Beck Depression Inventory - II

    Time frame: Baseline and Follow-Up (one month, three months, six months)

  12. Change on Quick Inventory of Depressive Symptoms - Self Report

    Time frame: Baseline and Follow-Up (one month, three months, six months)

  13. Change on State-Trait Anxiety Inventory (Trait scale)

    Time frame: Baseline and Follow-Up (one month, three months, six months)

  14. Change on Beck Anxiety Inventory

    Time frame: Baseline and Follow-Up (one month, three months, six months)

  15. Change on Life Orientation Test - Revised

    Time frame: Baseline and Follow-Up (one month, three months, six months)

  16. Change on Prospective Imagery Test

    Time frame: Baseline and Follow-Up (one month, three months, six months)

  17. Change on Behavioural Activation in Depression Scale

    Time frame: Baseline and Follow-Up (one month, three months, six months)

  18. Change on IAPT Toolkit

    Time frame: Baseline and Follow-Up (one month, three months, six months)

    Includes GAD-7, PHQ-9, Work and Social Adjustment Scale

  19. Change on Euroqol-5D

    Time frame: Baseline and Follow-Up (one month, three months, six months)

  20. Change on Neuroticism

    Time frame: Baseline and Follow-Up (one month, three months, six months)

  21. Image Generation Task

    Time frame: Post-Intervention (4 weeks)

    Task adapted from Sharot et al. (2007, Nature)

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Lupina Foundation

Registry information

Acronym: OxIGen

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 29, 2011
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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