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

NCT ID: NCT01488058

Last Updated: 2012-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 2

Waitlist control

Group Type OTHER

Waitlist Control

Intervention Type OTHER

Waitlist will receive iCBT at week 11

Group 1

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

Group Type EXPERIMENTAL

OxIGen + iCBT

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Waitlist Control

Waitlist will receive iCBT at week 11

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of New South Wales

OTHER

Sponsor Role collaborator

Alishia Williams

OTHER

Sponsor Role lead

Responsible Party

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Alishia Williams

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gavin Andrews, AO, MD

Role: PRINCIPAL_INVESTIGATOR

St. Vincent's Hospital, The University of New South Wales

Alishia Williams, PhD; MPsychol(Clinical)

Role: PRINCIPAL_INVESTIGATOR

St. Vincent's Hospital, The University of New South Wales

Locations

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St. Vincent's Hospital

Darlinghurst, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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ACTRN12611001221943

Identifier Type: REGISTRY

Identifier Source: secondary_id

11/055

Identifier Type: -

Identifier Source: org_study_id