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Psychotherapy for residual depression following initial treatment: effectiveness, relapse prevention and mechanisms of change
ISRCTN ISRCTN67561918
DOI 10.1186/ISRCTN67561918
ClinicalTrials.gov identifier
EudraCT number
Public title Psychotherapy for residual depression following initial treatment: effectiveness, relapse prevention and mechanisms of change
Scientific title
Acronym STEP-D
Serial number at source N/A
Study hypothesis Are Cognitive Behavioural Therapy (CBT) and InterPersonal Therapy (IPT) following initial treatment effective interventions that prevent relapse of recurrence of depression in the long-term? What are the mechanisms of change in CBT and IPT?
Lay summary Not provided at time of registration
Ethics approval Approval received from the local ethics committee (Medisch Ethische Commissie azM/UM) on the 5th December 2006 (ref: MEC 06-3-063).
Study design Randomised, controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Depression
Participants - inclusion criteria 1. One or more episodes of Major Depressive Disorder (MDD) in past two years
2. Initial treatment for depressive symptoms
3. Residual symptoms of depression (Beck Depression Inventory [BDI] more than or equal to ten)
Participants - exclusion criteria 1. Chronic depression
2. Concurrent treatment for depression
3. Severe co-morbidity
4. Medical conditions that explain depressive symptoms
Anticipated start date 01/08/2006
Anticipated end date 01/08/2011
Status of trial Completed
Patient information material
Target number of participants 180
Interventions 1. Cognitive Behaviour Therapy (CBT), N=75
2. InterPersonal Therapy (IPT), N=75
3. Eight-week waiting list, N=30

CBT= max. 20 sessions
IPT= max. 20 sessions

All interventions are delivered by qualified therapists under supervision at the Academic Riagg Maastricht.
Primary outcome measure(s) Depressive relapse/recurrence in the course of 24 months.
Secondary outcome measure(s) 1. Severity of depression (BDI)
2. Psychological problems
3. Health care consumption
4. Explicit and implicit mechanism of change measures
Sources of funding University Maastricht (UM) (The Netherlands)
Trial website http://www.stepd.nl
Publications 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21672217
Contact name Dr  Heleen  van Teeseling
  Address University Maastricht (UM)
Department of Medical, Clinical and Experimental Psychology
P.O. Box 616
  City/town Maastricht
  Zip/Postcode 6200 MD
  Country Netherlands
  Email h.vanteeseling@dmkep.unimaas.nl
Sponsor University Maastricht (UM) (The Netherlands)
  Address Department of Medical Clinical and Experimental Psychology (DMKEP)
P.O. Box 616
  City/town Maastricht
  Zip/Postcode 6200 MD
  Country Netherlands
  Sponsor website: http://www.unimaas.nl/default.asp?taal=en
Date applied 16/01/2007
Last edited 22/11/2011
Date ISRCTN assigned 16/01/2007
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