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Cognitive Bias Modification (CBM) and Internet Cognitive Behavioural Therapy (iCBT) for Depression- A Randomised Controlled Trial

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
OxIGen + iCBT
Waitlist Control
Sponsored by
Alishia Williams
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • St. Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Group 2

Group 1

Arm Description

Waitlist control

CBM intervention (OxIGen) plus Internet based Cognitive Behavioural Therapy for depression

Outcomes

Primary Outcome Measures

Change in score on the Beck Depression Inventory - second edition (BDI-II).

Secondary Outcome Measures

Change on the Scrambled Sentences Task (SST)- electronic version.
Change on Prospective Imagery Test (PIT).
Change on the Kessler-10 (K10).
Change on WHO Disability Assessment Scale (WHO-DAS).
Change on the Repetitive Thinking Questionnaire (RTQ).
Change on the State Trait Anxiety Inventory (STAI).
Change on the Ambiguous Sentence Task (AST).
Change in score on the Patient Health Questionnaire-9 (PHQ-9).

Full Information

First Posted
December 5, 2011
Last Updated
September 18, 2012
Sponsor
Alishia Williams
Collaborators
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT01488058
Brief Title
Cognitive Bias Modification (CBM) and Internet Cognitive Behavioural Therapy (iCBT) for Depression- A Randomised Controlled Trial
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alishia Williams
Collaborators
The University of New South Wales

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 2
Arm Type
Other
Arm Description
Waitlist control
Arm Title
Group 1
Arm Type
Experimental
Arm Description
CBM intervention (OxIGen) plus Internet based Cognitive Behavioural Therapy for depression
Intervention Type
Other
Intervention Name(s)
OxIGen + iCBT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waitlist Control
Intervention Description
Waitlist will receive iCBT at week 11
Primary Outcome Measure Information:
Title
Change in score on the Beck Depression Inventory - second edition (BDI-II).
Time Frame
Administered at baseline, post-intervention (1 week), and post treatment (iCBT; 11 weeks)
Secondary Outcome Measure Information:
Title
Change on the Scrambled Sentences Task (SST)- electronic version.
Time Frame
Administered at baseline, post-intervention (1 week).
Title
Change on Prospective Imagery Test (PIT).
Time Frame
Administered at baseline, post-intervention (1 week).
Title
Change on the Kessler-10 (K10).
Time Frame
Administered at baseline, before each iCBT lesson, and post-treatment (week 11).
Title
Change on WHO Disability Assessment Scale (WHO-DAS).
Time Frame
Administered baseline and post-treatment (iCBT; 11 weeks).
Title
Change on the Repetitive Thinking Questionnaire (RTQ).
Time Frame
Administered at baseline, post intervention (week 1), and post-treatment (iCBT; 11 weeks).
Title
Change on the State Trait Anxiety Inventory (STAI).
Time Frame
Administered at baseline, post intervention (week 1), and post-treatment (iCBT; 11 weeks).
Title
Change on the Ambiguous Sentence Task (AST).
Time Frame
Administered at baseline and post-intervention (week 1).
Title
Change in score on the Patient Health Questionnaire-9 (PHQ-9).
Time Frame
Administered at baseline, post intervention (week 1), and post treatment (week 11).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gavin Andrews, AO, MD
Organizational Affiliation
St. Vincent's Hospital, The University of New South Wales
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alishia Williams, PhD; MPsychol(Clinical)
Organizational Affiliation
St. Vincent's Hospital, The University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

Cognitive Bias Modification (CBM) and Internet Cognitive Behavioural Therapy (iCBT) for Depression- A Randomised Controlled Trial

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