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

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
OxIGen
OxIGen: control version
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Cognitive Bias, Internet

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MRC Cognition and Brain Sciences Unit
  • Department of Psychiatry, University of Oxford

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OxIGen program

OxIGen: control version

Arm Description

Internet based intervention taking place over 4 weeks

A control version of the internet-based OxIGen intervention

Outcomes

Primary Outcome Measures

Change in score on Beck Depression Inventory - II

Secondary Outcome Measures

Change in score on Quick Inventory of Depressive Symptoms - Self Report
Change in State-Trait Anxiety Inventory (Trait scale)
Change on Beck Anxiety Inventory
Change on Scrambled Sentences Task
Change on Life Orientation Test - Revised
Change on Prospective Imagery Test
Change on Behavioural Activation in Depression Scale
Change in IAPT Toolkit
Includes the GAD-7, PHQ-9 and Work and Social Adjustment Scale
Change on EuroQol-5D
Change in Neuroticism
Change on Beck Depression Inventory - II
Change on Quick Inventory of Depressive Symptoms - Self Report
Change on State-Trait Anxiety Inventory (Trait scale)
Change on Beck Anxiety Inventory
Change on Life Orientation Test - Revised
Change on Prospective Imagery Test
Change on Behavioural Activation in Depression Scale
Change on IAPT Toolkit
Includes GAD-7, PHQ-9, Work and Social Adjustment Scale
Change on Euroqol-5D
Change on Neuroticism
Image Generation Task
Task adapted from Sharot et al. (2007, Nature)

Full Information

First Posted
September 27, 2011
Last Updated
January 8, 2014
Sponsor
University of Oxford
Collaborators
Lupina Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01443234
Brief Title
OxIGen: Oxford Imagery Generation: Investigating the Effects of an Internet Based Computer Program in Depression
Acronym
OxIGen
Official Title
OxIGen: Oxford Imagery Generation: Investigating the Effects of an Internet Based Computer Program in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Lupina Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Cognitive Bias, Internet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OxIGen program
Arm Type
Experimental
Arm Description
Internet based intervention taking place over 4 weeks
Arm Title
OxIGen: control version
Arm Type
Placebo Comparator
Arm Description
A control version of the internet-based OxIGen intervention
Intervention Type
Other
Intervention Name(s)
OxIGen
Intervention Description
Internet-based intervention with 12 sessions over 4 weeks
Intervention Type
Other
Intervention Name(s)
OxIGen: control version
Intervention Description
A control version of the OxIGen internet-based intervention (i.e. identical but with putative active components removed)
Primary Outcome Measure Information:
Title
Change in score on Beck Depression Inventory - II
Time Frame
Baseline and post-intervention (4 weeks)
Secondary Outcome Measure Information:
Title
Change in score on Quick Inventory of Depressive Symptoms - Self Report
Time Frame
Baseline and post-intervention (4 weeks)
Title
Change in State-Trait Anxiety Inventory (Trait scale)
Time Frame
Baseline and Post-Intervention (4 weeks)
Title
Change on Beck Anxiety Inventory
Time Frame
Baseline and Post-Intervention (4 weeks)
Title
Change on Scrambled Sentences Task
Time Frame
Baseline and Post-Intervention (4 weeks)
Title
Change on Life Orientation Test - Revised
Time Frame
Baseline and Post-Intervention (4 weeks)
Title
Change on Prospective Imagery Test
Time Frame
Baseline and Post-Intervention (4 weeks)
Title
Change on Behavioural Activation in Depression Scale
Time Frame
Baseline and Post-Intervention (4 weeks)
Title
Change in IAPT Toolkit
Description
Includes the GAD-7, PHQ-9 and Work and Social Adjustment Scale
Time Frame
Baseline and Post-Intervention (4 weeks)
Title
Change on EuroQol-5D
Time Frame
Baseline and Post-Intervention (4 weeks)
Title
Change in Neuroticism
Time Frame
Baseline and Post-Intervention (4 weeks)
Title
Change on Beck Depression Inventory - II
Time Frame
Baseline and Follow-Up (one month, three months, six months)
Title
Change on Quick Inventory of Depressive Symptoms - Self Report
Time Frame
Baseline and Follow-Up (one month, three months, six months)
Title
Change on State-Trait Anxiety Inventory (Trait scale)
Time Frame
Baseline and Follow-Up (one month, three months, six months)
Title
Change on Beck Anxiety Inventory
Time Frame
Baseline and Follow-Up (one month, three months, six months)
Title
Change on Life Orientation Test - Revised
Time Frame
Baseline and Follow-Up (one month, three months, six months)
Title
Change on Prospective Imagery Test
Time Frame
Baseline and Follow-Up (one month, three months, six months)
Title
Change on Behavioural Activation in Depression Scale
Time Frame
Baseline and Follow-Up (one month, three months, six months)
Title
Change on IAPT Toolkit
Description
Includes GAD-7, PHQ-9, Work and Social Adjustment Scale
Time Frame
Baseline and Follow-Up (one month, three months, six months)
Title
Change on Euroqol-5D
Time Frame
Baseline and Follow-Up (one month, three months, six months)
Title
Change on Neuroticism
Time Frame
Baseline and Follow-Up (one month, three months, six months)
Title
Image Generation Task
Description
Task adapted from Sharot et al. (2007, Nature)
Time Frame
Post-Intervention (4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily A Holmes, D.Clin.Psy, PhD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
MRC Cognition and Brain Sciences Unit
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 7EF
Country
United Kingdom
Facility Name
Department of Psychiatry, University of Oxford
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7JX
Country
United Kingdom

12. IPD Sharing Statement

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

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