DepressionNCT01488058
Cognitive Bias Modification (CBM) and Internet Cognitive Behavioural Therapy (iCBT) for Depression- A Randomised Controlled Trial
A study testing OxIGen + iCBT in people with Depression, run by Alishia Williams at 1 site in Australia.
Trial summary
Cognitive accounts of depression and anxiety emphasize the importance of cognitive biases in the maintenance of disorders. One specific bias is the interpretation of ambiguous information. 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 + iCBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2011to Aug 2012
- Phase
- Interventional
- 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
- Meet Diagnostic and Statistical Manual of the American Psychiatric Association - 4th edition (DSM-IV) criteria for Major Depressive Disorder,
- Internet access + printer access,
- Australian resident,
- Fluent in written and spoken English.
Who cannot join
- Current substance abuse/dependence,
- Psychotic mental illness (Bipolar or Schizophrenia),
- Current or planned psychological treatment during study duration,
- Change in medication during last 1 month or intended change during study duration,
- Use of Benzodiazepines,
- Suicidal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial Comparing Internet Based Cognitive Behavioural Therapy for Major Depressive Disorder Plus a Cognitive Bias Modification Intervention (OxIGen) vs. Internet Based Cognitive Behavioural Therapy for Major Depressive Disorder vs. a Waitlist Control on Symptoms of Depression and Negative Interpretation Bias.
Cognitive accounts of depression and anxiety emphasize the importance of cognitive biases in the maintenance of disorders. One specific bias is the interpretation of ambiguous information. A negative interpretation bias is defined as a systematic tendency to interpret potentially ambiguous information in a negative rather than benign way and this bias has been associated with symptoms of depression. Research has led to the recent development of computerized cognitive bias modification (CBM) techniques to augment such biases and it has been suggested that CBM techniques may be useful as an adjunct to current treatments to enhance maintenance of treatment gains and minimize relapse rates. The fact that CBM procedures lend themselves to being delivered remotely, are cost-effective, and can be self-paced in ways that suit the patient make them an ideal candidate for inclusion in the Internet-based cognitive behavioural therapy (iCBT) programs currently offered through St. Vincent's Hospital and the University of New South Wales. Therefore, the primary aim of the current trial is to evaluate the acceptability and effectiveness of adding CBM procedures to the existing iCBT modules offered through St. Vincent's Hospital and the University of New South Wales. It is expected that iCBT + CBM will result in superior treatment outcomes as indexed by a standardized clinical battery.
- Conditions
- Depression
- Being tested
- OxIGen + iCBT, Waitlist Control
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxIGen + iCBTOther
OxIGen is an Internet-based intervention taking place over 1 week followed by iCBT, an Internet-based treatment for depression taking place over 10 weeks.
Waitlist ControlOther
Waitlist will receive iCBT at week 11
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Other | Waitlist control Receives: Other: Waitlist Control |
| Group 1 | Experimental | CBM intervention (OxIGen) plus Internet based Cognitive Behavioural Therapy for depression Receives: Other: OxIGen + iCBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on the Beck Depression Inventory - second edition (BDI-II).
Measured: Administered at baseline, post-intervention (1 week), and post treatment (iCBT; 11 weeks)
Secondary outcomes (8)
Change on the Scrambled Sentences Task (SST)- electronic version.
Measured: Administered at baseline, post-intervention (1 week).
Change on Prospective Imagery Test (PIT).
Measured: Administered at baseline, post-intervention (1 week).
Change on the Kessler-10 (K10).
Measured: Administered at baseline, before each iCBT lesson, and post-treatment (week 11).
Change on WHO Disability Assessment Scale (WHO-DAS).
Measured: Administered baseline and post-treatment (iCBT; 11 weeks).
Change on the Repetitive Thinking Questionnaire (RTQ).
Measured: Administered at baseline, post intervention (week 1), and post-treatment (iCBT; 11 weeks).
Change on the State Trait Anxiety Inventory (STAI).
Measured: Administered at baseline, post intervention (week 1), and post-treatment (iCBT; 11 weeks).
Change on the Ambiguous Sentence Task (AST).
Measured: Administered at baseline and post-intervention (week 1).
Change in score on the Patient Health Questionnaire-9 (PHQ-9).
Measured: Administered at baseline, post intervention (week 1), and post treatment (week 11).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2012
- Study completionAug 2012
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alishia Williams
- Sponsor type
- University, hospital or other
- Collaborators
- The University of New South Wales
- Responsible party
- Sponsor-investigator, Alishia Williams, St Vincent's Hospital
- Investigators
- Gavin Andrews, AO, MD, Principal investigator, St. Vincent's Hospital, The University of New South WalesAlishia Williams, PhD; MPsychol(Clinical), Principal investigator, St. Vincent's Hospital, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488058
- Sponsor's protocol ID
- 11/055
- Other IDs
- ACTRN12611001221943
- Status last verified
- Sep 2012
- First submitted
- 5 Dec 2011
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing Internet Based Cognitive Behavioural Therapy for Major Depressive Disorder Plus a Cognitive Bias Modification Intervention (OxIGen) vs. Internet Based Cognitive Behavioural Therapy for Major Depressive Disorder vs. a Waitlist Control on Symptoms of Depression and Negative Interpretation Bias.
- ClinicalTrials.gov ID
- NCT01488058
- Acronym / sponsor ID
- 11/055
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Alishia WilliamsUniversity, hospital or other
- Collaborators
- The University of New South Wales
- Study start
- Dec 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 8 Dec 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.
Cognitive accounts of depression and anxiety emphasize the importance of cognitive biases in the maintenance of disorders. One specific bias is the interpretation of ambiguous information. A negative interpretation bias is defined as a systematic tendency to interpret potentially ambiguous information in a negative rather than benign way and this bias has been associated with symptoms of depression. Research has led to the recent development of computerized cognitive bias modification (CBM) techniques to augment such biases and it has been suggested that CBM techniques may be useful as an adjunct to current treatments to enhance maintenance of treatment gains and minimize relapse rates. The fact that CBM procedures lend themselves to being delivered remotely, are cost-effective, and can be self-paced in ways that suit the patient make them an ideal candidate for inclusion in the Internet-based cognitive behavioural therapy (iCBT) programs currently offered through St. Vincent's Hospital and the University of New South Wales. Therefore, the primary aim of the current trial is to evaluate the acceptability and effectiveness of adding CBM procedures to the existing iCBT modules offered through St. Vincent's Hospital and the University of New South Wales. It is expected that iCBT + CBM will result in superior treatment outcomes as indexed by a standardized clinical battery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Other | Other: Waitlist ControlWaitlist control |
| Group 1 | Experimental | Other: OxIGen + iCBTCBM intervention (OxIGen) plus Internet based Cognitive Behavioural Therapy for depression |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet Diagnostic and Statistical Manual of the American Psychiatric Association - 4th edition (DSM-IV) criteria for Major Depressive Disorder,
- Internet access + printer access,
- Australian resident,
- Fluent in written and spoken English.
Key exclusion criteria (6 listed)
- Current substance abuse/dependence,
- Psychotic mental illness (Bipolar or Schizophrenia),
- Current or planned psychological treatment during study duration,
- Change in medication during last 1 month or intended change during study duration,
- Use of Benzodiazepines,
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 |
|---|---|---|
| OxIGen + iCBTOxIGen is an Internet-based intervention taking place over 1 week followed by iCBT, an Internet-based treatment for depression taking place over 10 weeks. | Other | Group 1 |
| Waitlist ControlWaitlist will receive iCBT at week 11 | Other | Group 2 |
Primary outcome
Change in score on the Beck Depression Inventory - second edition (BDI-II).
Time frame: Administered at baseline, post-intervention (1 week), and post treatment (iCBT; 11 weeks)
8 secondary outcomes
Change on the Scrambled Sentences Task (SST)- electronic version.
Time frame: Administered at baseline, post-intervention (1 week).
Change on Prospective Imagery Test (PIT).
Time frame: Administered at baseline, post-intervention (1 week).
Change on the Kessler-10 (K10).
Time frame: Administered at baseline, before each iCBT lesson, and post-treatment (week 11).
Change on WHO Disability Assessment Scale (WHO-DAS).
Time frame: Administered baseline and post-treatment (iCBT; 11 weeks).
Change on the Repetitive Thinking Questionnaire (RTQ).
Time frame: Administered at baseline, post intervention (week 1), and post-treatment (iCBT; 11 weeks).
Change on the State Trait Anxiety Inventory (STAI).
Time frame: Administered at baseline, post intervention (week 1), and post-treatment (iCBT; 11 weeks).
Change on the Ambiguous Sentence Task (AST).
Time frame: Administered at baseline and post-intervention (week 1).
Change in score on the Patient Health Questionnaire-9 (PHQ-9).
Time frame: Administered at baseline, post intervention (week 1), and post treatment (week 11).
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 20 Sep 2012.
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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.
Gavin Andrews, AO, MD principal investigator
St. Vincent's Hospital, The University of New South Wales
Alishia Williams, PhD; MPsychol(Clinical) principal investigator
St. Vincent's Hospital, The University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OxIGen + iCBT in people with Depression, run by Alishia Williams at 1 site in Australia.
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 4 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 20 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 the Beck Depression Inventory - second edition (BDI-II). (time frame: Administered at baseline, post-intervention (1 week), and post treatment (iCBT; 11 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 20 Sep 2012.