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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01488058




Registration number
NCT01488058
Ethics application status
Date submitted
5/12/2011
Date registered
8/12/2011
Date last updated
20/09/2012

Titles & IDs
Public title
Cognitive Bias Modification (CBM) and Internet Cognitive Behavioural Therapy (iCBT) for Depression- A Randomised Controlled Trial
Scientific 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.
Secondary ID [1] 0 0
ACTRN12611001221943
Secondary ID [2] 0 0
11/055
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - OxIGen + iCBT
Other interventions - Waitlist Control

Other: Group 2 - Waitlist control

Experimental: Group 1 - CBM intervention (OxIGen) plus Internet based Cognitive Behavioural Therapy for depression


Other interventions: OxIGen + iCBT
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.

Other interventions: Waitlist Control
Waitlist will receive iCBT at week 11
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in score on the Beck Depression Inventory - second edition (BDI-II).
Timepoint [1] 0 0
Administered at baseline, post-intervention (1 week), and post treatment (iCBT; 11 weeks)
Secondary outcome [1] 0 0
Change on the Scrambled Sentences Task (SST)- electronic version.
Timepoint [1] 0 0
Administered at baseline, post-intervention (1 week).
Secondary outcome [2] 0 0
Change on Prospective Imagery Test (PIT).
Timepoint [2] 0 0
Administered at baseline, post-intervention (1 week).
Secondary outcome [3] 0 0
Change on the Kessler-10 (K10).
Timepoint [3] 0 0
Administered at baseline, before each iCBT lesson, and post-treatment (week 11).
Secondary outcome [4] 0 0
Change on WHO Disability Assessment Scale (WHO-DAS).
Timepoint [4] 0 0
Administered baseline and post-treatment (iCBT; 11 weeks).
Secondary outcome [5] 0 0
Change on the Repetitive Thinking Questionnaire (RTQ).
Timepoint [5] 0 0
Administered at baseline, post intervention (week 1), and post-treatment (iCBT; 11 weeks).
Secondary outcome [6] 0 0
Change on the State Trait Anxiety Inventory (STAI).
Timepoint [6] 0 0
Administered at baseline, post intervention (week 1), and post-treatment (iCBT; 11 weeks).
Secondary outcome [7] 0 0
Change on the Ambiguous Sentence Task (AST).
Timepoint [7] 0 0
Administered at baseline and post-intervention (week 1).
Secondary outcome [8] 0 0
Change in score on the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [8] 0 0
Administered at baseline, post intervention (week 1), and post treatment (week 11).

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2012
Sample size
Target
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Other
Name
Alishia Williams
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01488058
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gavin Andrews, AO, MD
Address 0 0
St. Vincent's Hospital, The University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01488058