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Completed

NCT Number: NCT01787513

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBM

Other

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

iCBT

Other

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

Primary outcomes

  1. Change in Patient Health Questionnaire-9 (PHQ-9)scores

    Time frame: 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).

  2. Change in Beck Depression Inventory - second edition (BDI-II)scores

    Time frame: 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).

  3. Change in Ambiguous Sentence Task (AST)scores

    Time frame: Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline).

  4. Change in diagnostic status (MINI5 depression module)

    Time frame: Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).

Secondary outcomes

  1. Change in Kessler-10 (K10)scores

    Time frame: 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).

  2. Change in WHO Disability Assessment Scale (WHO-DAS)scores

    Time frame: Administered at baseline (T1, post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).

  3. Change in State Trait Anxiety Inventory (STAI)scores

    Time frame: Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).

  4. Change in Repetitive Thinking Questionnaire (RTQ)scores

    Time frame: 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).

  5. Change in Clinical Perfectionism Scale (PCS)scores

    Time frame: Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).

Sponsors and collaborators

Lead sponsor

St Vincent's Hospital, Sydney

Other

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 8, 2013
Registry last updated
Aug 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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