Psychotherapy for residual depression following initial treatment: effectiveness, relapse prevention and mechanisms of change

ISRCTN ISRCTN67561918
DOI https://doi.org/10.1186/ISRCTN67561918
Protocol serial number N/A
Sponsor University Maastricht (UM) (The Netherlands)
Funder University Maastricht (UM) (The Netherlands)
Submission date
16/01/2007
Registration date
16/01/2007
Last edited
22/11/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Heleen van Teeseling
Scientific

University Maastricht (UM)
Department of Medical, Clinical and Experimental Psychology
P.O. Box 616
Maastricht
6200 MD
Netherlands

Email h.vanteeseling@dmkep.unimaas.nl

Study information

Primary study designInterventional
Study designRandomised, controlled, parallel group trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymSTEP-D
Study objectivesAre 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(s)Approval received from the local ethics committee (Medisch Ethische Commissie azM/UM) on the 5th December 2006 (ref: MEC 06-3-063).
Health condition(s) or problem(s) studiedDepression
Intervention1. 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 typeOther
Primary outcome measure(s)

Depressive relapse/recurrence in the course of 24 months.

Key secondary outcome measure(s)

1. Severity of depression (BDI)
2. Psychological problems
3. Health care consumption
4. Explicit and implicit mechanism of change measures

Completion date01/08/2011

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration180
Key inclusion criteria1. 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)
Key exclusion criteria1. Chronic depression
2. Concurrent treatment for depression
3. Severe co-morbidity
4. Medical conditions that explain depressive symptoms
Date of first enrolment01/08/2006
Date of final enrolment01/08/2011

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Maastricht (UM)
Maastricht
6200 MD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 14/06/2011 Yes No
Study website Study website 11/11/2025 11/11/2025 No Yes