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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/NCT01787513




Registration number
NCT01787513
Ethics application status
Date submitted
4/02/2013
Date registered
8/02/2013
Date last updated
12/08/2014

Titles & IDs
Public title
Cognitive Bias Modification (CBM) Via Imagery and Internet Cognitive Behavioural Therapy (iCBT) for Depression
Scientific title
A Randomised Controlled Trial Comparing Internet Based Cognitive Behavioural Therapy for Major Depressive Disorder Plus a Cognitive Bias Modification Intervention (OxIGen)on Symptoms of Depression and Negative Interpretation Bias.
Secondary ID [1] 0 0
12/237
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 - CBM
Other interventions - iCBT

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.


Other interventions: CBM
CBM is an Internet-based intervention comprised of delivery of auditory scenarios taking place over 1 week.

Other interventions: iCBT
iCBT is a validated online CBT treatment program for depression delivered in 6 lessons over 10 weeks.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Patient Health Questionnaire-9 (PHQ-9)scores
Timepoint [1] 0 0
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).
Primary outcome [2] 0 0
Change in Beck Depression Inventory - second edition (BDI-II)scores
Timepoint [2] 0 0
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).
Primary outcome [3] 0 0
Change in Ambiguous Sentence Task (AST)scores
Timepoint [3] 0 0
Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline).
Primary outcome [4] 0 0
Change in diagnostic status (MINI5 depression module)
Timepoint [4] 0 0
Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Secondary outcome [1] 0 0
Change in Kessler-10 (K10)scores
Timepoint [1] 0 0
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).
Secondary outcome [2] 0 0
Change in WHO Disability Assessment Scale (WHO-DAS)scores
Timepoint [2] 0 0
Administered at baseline (T1, post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Secondary outcome [3] 0 0
Change in State Trait Anxiety Inventory (STAI)scores
Timepoint [3] 0 0
Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Secondary outcome [4] 0 0
Change in Repetitive Thinking Questionnaire (RTQ)scores
Timepoint [4] 0 0
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).
Secondary outcome [5] 0 0
Change in Clinical Perfectionism Scale (PCS)scores
Timepoint [5] 0 0
Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).

Eligibility
Key inclusion criteria
- 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
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)

- Change in medication or psychological treatment during last 1 month or intended change
during study duration

- Use of Benzodiazepines

- Severe depression (PHQ9> 23)

- 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
1/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
121
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
St Vincent's Hospital, Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01787513
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gavin Andrews, MD
Address 0 0
UNSW; ST. Vincent's Hospital
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/NCT01787513