REFRAMEd - REFRactory depression: Mechanisms and Effectiveness of radically open-dialectical behaviour therapy

• Register: ISRCTN
• Last refreshed on: 26 August 2019
• Main ID: ISRCTN85784627
• Date of registration: 10/08/2011
• Prospective Registration: Yes
• Primary sponsor: University of Southampton (UK)
• Public title: REFRAMEd - REFRactory depression: Mechanisms and Effectiveness of radically open-dialectical behaviour therapy
• Scientific title: REFRAMEd - REFRactory depression: Mechanisms and Effectiveness of radically open-dialectical behaviour therapy: a randomised controlled trial
• Date of first enrolment: 01/01/2012
• Target sample size: 276
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN85784627
• Study type: Interventional
• Study design: Randomised interventional treatment trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Roelie Hempel

Key inclusion & exclusion criteria

Inclusion criteria:
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)
3. Have a HAMD score of at least 15
4. Have treatment resistant depression (TRD) as defined by two or more previous episodes of depression and in their current episode to have taken an adequate dose of ADM for more than 6 weeks without symptom relief
5. Male and female participants

Exclusion criteria:
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
3. Have a primary diagnosis of substance dependence or substance abuse disorder


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Depression
Mental and Behavioural Disorders
Recurrent depressive disorder, unspecified

Intervention(s)

Current interventions as of 17/06/2014:
Radically Open Dialectical Behaviour Therapy for over-controlled behaviours followed up at 12 months.

Previous interventions:
Dialectical Behaviour Therapy, for emotionally over-controlled behaviours followed up at 12 months

Primary Outcome(s)

Hamilton Rating Scale for Depression measured before treatment, after treatment, 6 months after treatment, and 12 months after treatment

Secondary Outcome(s)

1. Depression remission
2. Suicide ideation and behaviour
3. Health economics

Secondary ID(s)

10234

Source(s) of Monetary Support

Medical Research Council (UK), Ref: EME 09/150/12

Ethics review

Status:
Approval date:
Contact:

First MREC, 20/06/2011, ref: 11/SC/0146

Results

• Results available: Yes
• Date Completed: 01/09/2014