Clinical trial NCT01787513: Cognitive Bias Modification (CBM) Via Imagery and Internet Cognitive Behavioural Therapy (iCBT) for Depression
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: St Vincent's Hospital, Sydney
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)scores
timeFrame: 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).
measure: Change in Beck Depression Inventory - second edition (BDI-II)scores
timeFrame: 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).
measure: Change in Ambiguous Sentence Task (AST)scores
timeFrame: Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline).
measure: Change in diagnostic status (MINI5 depression module)
timeFrame: Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Secondary outcomes:
measure: Change in Kessler-10 (K10)scores
timeFrame: 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).
measure: Change in WHO Disability Assessment Scale (WHO-DAS)scores
timeFrame: Administered at baseline (T1, post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
measure: Change in State Trait Anxiety Inventory (STAI)scores
timeFrame: Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
measure: Change in Repetitive Thinking Questionnaire (RTQ)scores
timeFrame: 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).
measure: Change in Clinical Perfectionism Scale (PCS)scores
timeFrame: Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
Study officials:
affiliation: UNSW; ST. Vincent's Hospital
name: Gavin Andrews, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNSW; ST Vincent's Hospital
name: Alishia Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.