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A randomised controlled trial comparing Internet based cognitive behavioural therapy for major depressive disorder plus a cognitive bias modification intervention (OxIGen) version A vs. Internet based cognitive behavioural therapy for major depressive disorder plus a cognitive bias modification intervention (OxIGen) version B 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 (active version) will result in superior treatment outcomes as indexed by a standardized clinical battery compared to iCBT + CBM (control version).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBM Version A + iCBT | Experimental | CBM Version A is an Internet-based intervention taking place over 1 week followed by iCBT, an Internet-based treatment for depression taking place over 10 weeks. |
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| CBM Version B (Control) + iCBT | Placebo Comparator | CBM Version B (Control) is an Internet-based intervention taking place over 1 week (identical to CBM Version A without the putative active components) followed by iCBT, an Internet-based treatment for depression taking place over 10 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBM | Other | CBM is an Internet-based intervention comprised of delivery of auditory scenarios taking place over 1 week. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Health Questionnaire-9 (PHQ-9)scores | Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4). | |
| Change in Beck Depression Inventory - second edition (BDI-II)scores | Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4). | |
| Change in Ambiguous Sentence Task (AST)scores | Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline). | |
| Change in diagnostic status (MINI5 depression module) | Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Kessler-10 (K10)scores | Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4). | |
| Change in WHO Disability Assessment Scale (WHO-DAS)scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gavin Andrews, MD | UNSW; ST. Vincent's Hospital | Principal Investigator |
| Alishia Williams, PhD | UNSW; ST Vincent's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24171941 | Derived | Williams AD, Blackwell SE, Holmes EA, Andrews G. Positive imagery cognitive bias modification (CBM) and internet-based cognitive behavioural therapy (iCBT) versus control CBM and iCBT for depression: study protocol for a parallel-group randomised controlled trial. BMJ Open. 2013 Oct 29;3(10):e004049. doi: 10.1136/bmjopen-2013-004049. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| iCBT | Other | iCBT is a validated online CBT treatment program for depression delivered in 6 lessons over 10 weeks. |
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| Administered at baseline (T1, post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4). |
| Change in State Trait Anxiety Inventory (STAI)scores | Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4). |
| Change in Repetitive Thinking Questionnaire (RTQ)scores | Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4). |
| Change in Clinical Perfectionism Scale (PCS)scores | Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4). |