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

NCT01787513 | Completed DMC

• 1 other identifier: 12/237
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (4)

• 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).

• 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).

• Change in Ambiguous Sentence Task (AST)scores

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

• 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).

Secondary Outcomes (5)

• 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).

• 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).

• 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).

• 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).

• 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).

Study Arms (2)

CBM Version A + iCBT

EXPERIMENTAL

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.

Other: CBM; Other: iCBT

CBM Version B (Control) + iCBT

PLACEBO COMPARATOR

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.

Other: CBM; Other: iCBT

Interventions

CBM OTHER

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

CBM Version A + iCBT; CBM Version B (Control) + iCBT

iCBT OTHER

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

CBM Version A + iCBT; CBM Version B (Control) + iCBT

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 and 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)
• Change in medication or psychological treatment during last 1 month or intended change during study duration
• Use of Benzodiazepines
• Severe depression (PHQ9\> 23)
• Suicidal

Sponsors & Collaborators

• St Vincent's Hospital, Sydney: lead

Study Sites (1)

St. Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Related Publications (1)

• 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.

  PMID: 24171941 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Gavin Andrews, MD

  UNSW; ST. Vincent's Hospital

  PRINCIPAL INVESTIGATOR

• Alishia Williams, PhD

  UNSW; ST Vincent's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 8, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 12, 2014

Record last verified: 2014-08

Locations

AU (1)