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

NCT01488058 | Completed DMC

• 2 other identifiers: 11/055ACTRN12611001221943
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

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

  Administered at baseline, post-intervention (1 week), and post treatment (iCBT; 11 weeks)

Secondary Outcomes (8)

• Change on the Scrambled Sentences Task (SST)- electronic version.

  Administered at baseline, post-intervention (1 week).

• Change on Prospective Imagery Test (PIT).

  Administered at baseline, post-intervention (1 week).

• Change on the Kessler-10 (K10).

  Administered at baseline, before each iCBT lesson, and post-treatment (week 11).

• Change on WHO Disability Assessment Scale (WHO-DAS).

  Administered baseline and post-treatment (iCBT; 11 weeks).

• Change on the Repetitive Thinking Questionnaire (RTQ).

  Administered at baseline, post intervention (week 1), and post-treatment (iCBT; 11 weeks).

Study Arms (2)

Group 2

OTHER

Waitlist control

Other: Waitlist Control

Group 1

EXPERIMENTAL

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

Other: OxIGen + iCBT

Interventions

OxIGen + iCBT 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.

Group 1

Waitlist Control OTHER

Waitlist will receive iCBT at week 11

Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alishia Williams: lead
• The University of New South Wales: collaborator

Study Sites (1)

St. Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Gavin Andrews, AO, MD

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

  PRINCIPAL INVESTIGATOR

• Alishia Williams, PhD; MPsychol(Clinical)

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 8, 2011
• Study Start: December 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 20, 2012

Record last verified: 2012-09

Locations

AU (1)