DepressionPhase 2OxIGenNCT01443234
OxIGen: Oxford Imagery Generation: Investigating the Effects of an Internet Based Computer Program in Depression
A Phase 2 study testing OxIGen in people with Depression, run by University of Oxford at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- OxIGen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2012to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
MRC Cognition and Brain Sciences Unit
Cambridge, Cambridgeshire, CB2 7EF
Department of Psychiatry, University of Oxford
Oxford, Oxfordshire, OX3 7JX
About this study
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.
- Conditions
- Depression
- Being tested
- OxIGen, OxIGen: control version
- Keywords
- Depression, Cognitive Bias, Internet
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxIGenOther
Internet-based intervention with 12 sessions over 4 weeks
OxIGen: control versionOther
A control version of the OxIGen internet-based intervention (i.e. identical but with putative active components removed)
| Study group | Role | What they receive |
|---|---|---|
| OxIGen program | Experimental | Internet based intervention taking place over 4 weeks Receives: Other: OxIGen |
| OxIGen: control version | Placebo comparator | A control version of the internet-based OxIGen intervention Receives: Other: OxIGen: control version |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on Beck Depression Inventory - II
Measured: Baseline and post-intervention (4 weeks)
Secondary outcomes (21)
Change in score on Quick Inventory of Depressive Symptoms - Self Report
Measured: Baseline and post-intervention (4 weeks)
Change in State-Trait Anxiety Inventory (Trait scale)
Measured: Baseline and Post-Intervention (4 weeks)
Change on Beck Anxiety Inventory
Measured: Baseline and Post-Intervention (4 weeks)
Change on Scrambled Sentences Task
Measured: Baseline and Post-Intervention (4 weeks)
Change on Life Orientation Test - Revised
Measured: Baseline and Post-Intervention (4 weeks)
Change on Prospective Imagery Test
Measured: Baseline and Post-Intervention (4 weeks)
Change on Behavioural Activation in Depression Scale
Measured: Baseline and Post-Intervention (4 weeks)
Change in IAPT Toolkit
Includes the GAD-7, PHQ-9 and Work and Social Adjustment Scale
Measured: Baseline and Post-Intervention (4 weeks)
Change on EuroQol-5D
Measured: Baseline and Post-Intervention (4 weeks)
Change in Neuroticism
Measured: Baseline and Post-Intervention (4 weeks)
Change on Beck Depression Inventory - II
Measured: Baseline and Follow-Up (one month, three months, six months)
Change on Quick Inventory of Depressive Symptoms - Self Report
Measured: Baseline and Follow-Up (one month, three months, six months)
Change on State-Trait Anxiety Inventory (Trait scale)
Measured: Baseline and Follow-Up (one month, three months, six months)
Change on Beck Anxiety Inventory
Measured: Baseline and Follow-Up (one month, three months, six months)
Change on Life Orientation Test - Revised
Measured: Baseline and Follow-Up (one month, three months, six months)
Change on Prospective Imagery Test
Measured: Baseline and Follow-Up (one month, three months, six months)
Change on Behavioural Activation in Depression Scale
Measured: Baseline and Follow-Up (one month, three months, six months)
Change on IAPT Toolkit
Includes GAD-7, PHQ-9, Work and Social Adjustment Scale
Measured: Baseline and Follow-Up (one month, three months, six months)
Change on Euroqol-5D
Measured: Baseline and Follow-Up (one month, three months, six months)
Change on Neuroticism
Measured: Baseline and Follow-Up (one month, three months, six months)
Image Generation Task
Task adapted from Sharot et al. (2007, Nature)
Measured: Post-Intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startFeb 2012
- Primary completionApr 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Lupina Foundation
- Responsible party
- Sponsor
- Investigators
- Emily A Holmes, D.Clin.Psy, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443234
- Sponsor's protocol ID
- 11/SC/0278
- Acronym
- OxIGen
- Status last verified
- Jun 2013
- First submitted
- 27 Sep 2011
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OxIGen: Oxford Imagery Generation: Investigating the Effects of an Internet Based Computer Program in Depression
- ClinicalTrials.gov ID
- NCT01443234
- Acronym / sponsor ID
- OxIGen / 11/SC/0278
- Conditions
- Depression
- Keywords
- Depression, Cognitive Bias, Internet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Lupina Foundation
- Study start
- Feb 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OxIGen program | Experimental | Other: OxIGenInternet based intervention taking place over 4 weeks |
| OxIGen: control version | Placebo comparator | Other: OxIGen: control versionA control version of the internet-based OxIGen intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxIGenInternet-based intervention with 12 sessions over 4 weeks | Other | OxIGen program |
| OxIGen: control versionA control version of the OxIGen internet-based intervention (i.e. identical but with putative active components removed) | Other | OxIGen: control version |
Primary outcome
Change in score on Beck Depression Inventory - II
Time frame: Baseline and post-intervention (4 weeks)
21 secondary outcomes
Change in score on Quick Inventory of Depressive Symptoms - Self Report
Time frame: Baseline and post-intervention (4 weeks)
Change in State-Trait Anxiety Inventory (Trait scale)
Time frame: Baseline and Post-Intervention (4 weeks)
Change on Beck Anxiety Inventory
Time frame: Baseline and Post-Intervention (4 weeks)
Change on Scrambled Sentences Task
Time frame: Baseline and Post-Intervention (4 weeks)
Change on Life Orientation Test - Revised
Time frame: Baseline and Post-Intervention (4 weeks)
Change on Prospective Imagery Test
Time frame: Baseline and Post-Intervention (4 weeks)
Change on Behavioural Activation in Depression Scale
Time frame: Baseline and Post-Intervention (4 weeks)
Change in IAPT Toolkit
Time frame: Baseline and Post-Intervention (4 weeks)
Change on EuroQol-5D
Time frame: Baseline and Post-Intervention (4 weeks)
Change in Neuroticism
Time frame: Baseline and Post-Intervention (4 weeks)
Change on Beck Depression Inventory - II
Time frame: Baseline and Follow-Up (one month, three months, six months)
Change on Quick Inventory of Depressive Symptoms - Self Report
Time frame: Baseline and Follow-Up (one month, three months, six months)
Change on State-Trait Anxiety Inventory (Trait scale)
Time frame: Baseline and Follow-Up (one month, three months, six months)
Change on Beck Anxiety Inventory
Time frame: Baseline and Follow-Up (one month, three months, six months)
Change on Life Orientation Test - Revised
Time frame: Baseline and Follow-Up (one month, three months, six months)
Change on Prospective Imagery Test
Time frame: Baseline and Follow-Up (one month, three months, six months)
Change on Behavioural Activation in Depression Scale
Time frame: Baseline and Follow-Up (one month, three months, six months)
Change on IAPT Toolkit
Time frame: Baseline and Follow-Up (one month, three months, six months)
Change on Euroqol-5D
Time frame: Baseline and Follow-Up (one month, three months, six months)
Change on Neuroticism
Time frame: Baseline and Follow-Up (one month, three months, six months)
Image Generation Task
Time frame: Post-Intervention (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily A Holmes, D.Clin.Psy, PhD principal investigator
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OxIGen in people with Depression, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score on Beck Depression Inventory - II (time frame: Baseline and post-intervention (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.