Secondary identifying numbers | ACTRN12613000139774 |
Source(s) of monetary or material support | National Health and Medical Research Council of Australia; Bupa Health Foundation |
Primary sponsor | St Vincent's Hospital, Sydney |
Secondary sponsor(s) | |
Contact for public queries | AW, GA |
Contact for scientific queries | AW, GA |
Public title | Cognitive bias modification (CBM) via imagery and internet cognitive behavioural therapy (iCBT) for depression |
Scientific title | CBM via iCBT for depression |
Countries of recruitment | Australia |
Health condition(s) or problem(s) studied | Major depressive disorder |
Intervention(s) | Experimental: CBM Version A+iCBT
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.
Placebo Comparator: CBM Version B (Control) + iCBT
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 |
Key inclusion and exclusion criteria | Inclusion: 18–65 years of age; Meet Diagnostic and Statistical Manual of the American Psychiatric Association—4th edition (DSM-IV) criteria for major depressive disorder; internet and printer access; Australian resident; fluent in written and spoken English
Exclusion: current substance abuse/dependence; psychotic mental illness (bipolar or schizophrenia); change in medication or psychological treatment during last 1 month or intended change during study duration; use of Benzodiazepines, severe depression (PHQ9>23), Suicidal (PHQ9 item 9>2) |
Study type | Interventional |
Date of first enrolment | 13 February 2013 |
Target sample size | 80 |
Recruitment status | Recruiting |
Primary outcome(s) | Change in: Patient Health Questionnaire-9 (PHQ-9); Beck Depression Inventory—second edition (BDI-II); Ambiguous Scenarios Test-Depression (AST-D); diagnostic status (MINI5 depression module) |
Key secondary outcomes | Change in: Kessler-10 (K10); WHO Disability Assessment Scale (WHO-DAS); State Trait Anxiety Inventory (STAI); Repetitive Thinking Questionnaire (RTQ); Clinical Perfectionism Questionnaire (CPQ) |