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

St Vincent's Hospital, Sydney

Status: Completed

Conditions: Depression

Treatments: Other: CBM; Other: iCBT

Study type: Interventional

Funder types: Other

Identifiers

NCT01787513

12/237

Details and patient eligibility

About

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.

Full 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).

Enrollment: 121 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups, including a placebo group

CBM Version A + iCBT

Experimental group

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.

Treatment:

Other: iCBT

Other: CBM

CBM Version B (Control) + iCBT

Placebo Comparator group

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.

Treatment:

Other: iCBT

Other: CBM