REFRAMEd - REFRactory depression: Mechanisms and Effectiveness of radically open-dialectical behaviour therapy: a randomised controlled trial

niversity of Southampton (UK)0 sites250 target enrollmentAugust 10, 2011

Overview

Registry

who.int

Start Date

August 10, 2011

End Date

September 1, 2014

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Southampton (UK)

•Current inclusion criteria as of 15/08/2012:
•1\. Aged 18 years or over
•2\. Have a current diagnosis of major depressive disorder (MDD; as defined by SCID\-I)
•3\. Have refractory depression (RD), operationalized as having had two or more previous episodes of depression or meeting the criteria for chronic depression
•4\. Currently taking antidepressant medication
•5\. Have received this medication for 6 weeks or more at BNF recommended doses
•6\. Have a Hamilton Depression Rating score of at least 15
•Previous inclusion criteria until 15/08/2012:
•1\. Aged 18 years or over
•2\. Have a current diagnosis of major depressive disorder (MDD)

•Current exclusion criteria as of 15/08/2012:
•1\. IQ less than 70 or insufficient English to complete treatment and assessment
•2\. Meet DSM\-IV criteria for dramatic\-erratic PD (borderline, histrionic, antisocial or narcissistic PD), bipolar depression, or psychosis
•3\. Have a primary diagnosis of substance dependence or substance abuse disorder
•4\. Currently receiving standard DBT
•5\. On a waiting list for standard DBT
•6\. Have received standard DBT within the last 6 months (please note that patients who have completed a course of DBT more than 6 months ago are eligible if they meet all other criteria)
•Previous exclusion criteria until 15/08/2012:
•1\. Have an IQ \< 70 or insufficient English to complete treatment and assessment
•2\. Meet DSM\-IV criteria for emotionally undercontrolled PD (borderline, histrionic, antisocial, narcissistic PD), bipolar depression or psychosis