Contact information
Type
Scientific
Primary contact
Dr Heleen van Teeseling
ORCID ID
Contact details
University Maastricht (UM)
Department of Medical
Clinical and Experimental Psychology
P.O. Box 616
Maastricht
6200 MD
Netherlands
h.vanteeseling@dmkep.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
STEP-D
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?
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Depression
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Depressive relapse/recurrence in the course of 24 months.
Secondary outcome measures
1. Severity of depression (BDI)
2. Psychological problems
3. Health care consumption
4. Explicit and implicit mechanism of change measures
Overall trial start date
01/08/2006
Overall trial end date
01/08/2011
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
180
Participant exclusion criteria
1. Chronic depression
2. Concurrent treatment for depression
3. Severe co-morbidity
4. Medical conditions that explain depressive symptoms
Recruitment start date
01/08/2006
Recruitment end date
01/08/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Maastricht (UM)
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
University Maastricht (UM) (The Netherlands)
Sponsor details
Department of Medical Clinical and Experimental Psychology (DMKEP)
P.O. Box 616
Maastricht
6200 MD
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University Maastricht (UM) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21672217
Publication citations
-
Protocol
Lemmens LH, Arntz A, Peeters FP, Hollon SD, Roefs A, Huibers MJ, Effectiveness, relapse prevention and mechanisms of change of cognitive therapy vs. interpersonal therapy for depression: Study protocol for a randomised controlled trial., Trials, 2011, 12, 150, doi: 10.1186/1745-6215-12-150.