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

NCT ID: NCT01787513

Last Updated: 2014-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-08-31

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).

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CBM

Intervention Type: OTHER

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

iCBT

Intervention Type: OTHER

iCBT is a validated online CBT treatment program for depression delivered in 6 lessons over 10 weeks.

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.

Group Type: PLACEBO_COMPARATOR

CBM

Intervention Type: OTHER

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

iCBT

Intervention Type: OTHER

iCBT is a validated online CBT treatment program for depression delivered in 6 lessons over 10 weeks.

Interventions

CBM

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

Intervention Type: OTHER

iCBT

iCBT is a validated online CBT treatment program for depression delivered in 6 lessons over 10 weeks.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St Vincent's Hospital, Sydney

OTHER

Sponsor Role: lead

Responsible Party

Alishia Williams

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gavin Andrews, MD

Role: PRINCIPAL_INVESTIGATOR

UNSW; ST. Vincent's Hospital

Alishia Williams, PhD

Role: PRINCIPAL_INVESTIGATOR

UNSW; ST Vincent's Hospital

Locations

St. Vincent's Hospital

Darlinghurst, New South Wales, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 24171941 (View on PubMed)

Other Identifiers

12/237

Identifier Type: -

Identifier Source: org_study_id