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Table 1 Items from the World Health Organization trial registration data set

From: Internet-based cognitive bias modification for obsessive compulsive disorder: study protocol for a randomized controlled trial

Secondary identifying numbers

ACTRN12613001130752

Source(s) of monetary or material support

 

Primary sponsor

St Vincent’s Hospital, Sydney

Secondary sponsor(s)

 

Contact for public queries

AW, GA

Contact for scientific queries

AW, GA

Public title

Cognitive Bias Modification (CBM) and Obsessive Compulsive Beliefs

Scientific title

Randomized controlled trial comparing Internet-based cognitive bias modification (active version) for obsessive compulsive disorder versus Internet based cognitive bias modification (control version) on negative interpretation bias.

Countries of recruitment

Australia

Health condition(s) or problem(s) studied

Obsessive Compulsive Disorder

Intervention(s)

Experimental: CBM Version A (Active treatment)

CBM Version A is an Internet-based intervention taking place over 1 week.

Placebo Comparator: CBM Version B (Control)

CBM Version B (Control) is an Internet-based intervention taking place over 1 week (identical to CBM Version A without the putative active components).

Key inclusion and exclusion criteria

Inclusion: 18 to 65 years of age; Meet Diagnostic and Statistical Manual of the American Psychiatric Association - 4th edition (DSM-IV) criteria for current or lifetime Obsessive Compulsive Disorder; Internet and printer access; Australian resident; fluent in written and spoken English

Exclusion: 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 (PHQ9 item 9 > 2)

Study type

Interventional

Date of first enrollment

24 October 2013

Target sample size

70

Recruitment status

Recruiting

Primary outcome(s)

Change in: Interpretations bias (the Ambiguous Scenarios Test for OCD; AST-OCD), the Word Sentence Association Test for OCD (WSAO), and the OC Bias measure.

Key secondary outcomes

Change in: The Obsessive Beliefs Questionnaire-TRIP (OBQ-TRIP), the Patient Health Questionnaire (PHQ-9); the Dimensional Obsessive-Compulsive Scale (DOCS). Change in diagnostic status will be indexed using the OCD M.I.N.I Module at baseline and follow up.