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Cognitive Bias Modification (CBM) Via Imagery and Internet Cognitive Behavioural Therapy (iCBT) for Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
CBM
iCBT
Sponsored by
St Vincent's Hospital, Sydney
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 and printer access
  • Australian resident
  • Fluent in written and spoken English

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

Sites / Locations

  • St. Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CBM Version A + iCBT

CBM Version B (Control) + iCBT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Patient Health Questionnaire-9 (PHQ-9)scores
Change in Beck Depression Inventory - second edition (BDI-II)scores
Change in Ambiguous Sentence Task (AST)scores
Change in diagnostic status (MINI5 depression module)

Secondary Outcome Measures

Change in Kessler-10 (K10)scores
Change in WHO Disability Assessment Scale (WHO-DAS)scores
Change in State Trait Anxiety Inventory (STAI)scores
Change in Repetitive Thinking Questionnaire (RTQ)scores
Change in Clinical Perfectionism Scale (PCS)scores

Full Information

First Posted
February 4, 2013
Last Updated
August 10, 2014
Sponsor
St Vincent's Hospital, Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT01787513
Brief Title
Cognitive Bias Modification (CBM) Via Imagery and Internet Cognitive Behavioural Therapy (iCBT) for Depression
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Vincent's Hospital, Sydney

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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 (active version) will result in superior treatment outcomes as indexed by a standardized clinical battery compared to iCBT + CBM (control version).

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
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBM Version A + iCBT
Arm Type
Experimental
Arm Description
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.
Arm Title
CBM Version B (Control) + iCBT
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CBM
Intervention Description
CBM is an Internet-based intervention comprised of delivery of auditory scenarios taking place over 1 week.
Intervention Type
Other
Intervention Name(s)
iCBT
Intervention Description
iCBT is a validated online CBT treatment program for depression delivered in 6 lessons over 10 weeks.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 (PHQ-9)scores
Time Frame
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).
Title
Change in Beck Depression Inventory - second edition (BDI-II)scores
Time Frame
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).
Title
Change in Ambiguous Sentence Task (AST)scores
Time Frame
Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline).
Title
Change in diagnostic status (MINI5 depression module)
Time Frame
Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Secondary Outcome Measure Information:
Title
Change in Kessler-10 (K10)scores
Time Frame
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).
Title
Change in WHO Disability Assessment Scale (WHO-DAS)scores
Time Frame
Administered at baseline (T1, post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Title
Change in State Trait Anxiety Inventory (STAI)scores
Time Frame
Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Title
Change in Repetitive Thinking Questionnaire (RTQ)scores
Time Frame
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).
Title
Change in Clinical Perfectionism Scale (PCS)scores
Time Frame
Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).

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 and printer access Australian resident Fluent in written and spoken English 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gavin Andrews, MD
Organizational Affiliation
UNSW; ST. Vincent's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alishia Williams, PhD
Organizational Affiliation
UNSW; ST Vincent's Hospital
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

Citations:
PubMed Identifier
24171941
Citation
Williams AD, Blackwell SE, Holmes EA, Andrews G. Positive imagery cognitive bias modification (CBM) and internet-based cognitive behavioural therapy (iCBT) versus control CBM and iCBT for depression: study protocol for a parallel-group randomised controlled trial. BMJ Open. 2013 Oct 29;3(10):e004049. doi: 10.1136/bmjopen-2013-004049.
Results Reference
derived

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Cognitive Bias Modification (CBM) Via Imagery and Internet Cognitive Behavioural Therapy (iCBT) for Depression

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