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

Depression Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787513
• Other study ID #: 12/237
• Status: Completed
• Phase: N/A
• First received: February 4, 2013
• Last updated: August 10, 2014
• Start date: February 2013
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: St Vincent's Hospital, Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: St. Vincent's Hospital HREC
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• CBM
CBM is an Internet-based intervention comprised of delivery of auditory scenarios taking place over 1 week.
• iCBT
iCBT is a validated online CBT treatment program for depression delivered in 6 lessons over 10 weeks.

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital	Darlinghurst	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
St Vincent's Hospital, Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Health Questionnaire-9 (PHQ-9)scores		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).	No
Primary	Change in Beck Depression Inventory - second edition (BDI-II)scores		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).	No
Primary	Change in Ambiguous Sentence Task (AST)scores		Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline).	No
Primary	Change in diagnostic status (MINI5 depression module)		Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).	No
Secondary	Change in Kessler-10 (K10)scores		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).	No
Secondary	Change in WHO Disability Assessment Scale (WHO-DAS)scores		Administered at baseline (T1, post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).	No
Secondary	Change in State Trait Anxiety Inventory (STAI)scores		Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).	No
Secondary	Change in Repetitive Thinking Questionnaire (RTQ)scores		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).	No
Secondary	Change in Clinical Perfectionism Scale (PCS)scores		Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).	No