Condition category
Mental and Behavioural Disorders
Date applied
16/01/2007
Date assigned
16/01/2007
Last edited
22/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.stepd.nl

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

http://www.unimaas.nl/default.asp?taal=en

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

  1. 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.

Additional files

Editorial Notes