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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01488058