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Cited by 37Psychotherapy Techniques and ApplicationsAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesTreatment of Major Depression

The generalizability of psychotherapy efficacy trials in major depressive disorder: an analysis of the influence of patient selection in efficacy trials on symptom outcome in daily practice

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van der Lem, Rosalind, de Wever, Wouter WH, van der Wee, Nic JA, van Veen, Tineke, Cuijpers, Pim, Zitman, Frans G·2012·BMC Psychiatry
DOI 10.1186/1471-244x-12-192PMC PMC3572434
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Abstract

BACKGROUND: Treatment guidelines for major depressive disorder (MDD) are based on results from randomized clinical trials, among others in psychotherapy efficacy trials. However, patients in these trials differ from routine practice patients since trials use stringent criteria for patient selection. It is unknown whether the exclusion criteria used in psychotherapy efficacy trials (PETs) influence symptom outcome in clinical practice. We first explored which exclusion criteria are used in PETs. Second, we investigated the influence of commonly used exclusion criteria on symptom outcome in routine clinical practice. METHODS: We performed an extensive literature search in PubMed, PsycInfo and additional databases for PETs for MDD. From these, we identified commonly used exclusion criteria. We investigated the influence of exclusion criteria on symptom outcome by multivariate regression models in a sample of patients suffering from MDD according to the MINIplus from a routine clinical practice setting (n=598). Data on routine clinical practice patients were gathered through Routine Outcome Monitoring. RESULTS: We selected 20 PETs and identified the following commonly used exclusion criteria: 'a baseline severity threshold of HAM-D≤14', 'current or past abuse or dependence of alcohol and/or drugs' and 'previous use of medication or ECT'. In our routine clinical practice sample of patients suffering from MDD (n=598), presence of 'current or past abuse of or dependence on alcohol and/or drugs' had no significant influence on outcome.'Meeting a baseline severity threshold of HAM-D≤14' and 'previous use of medication or ECT' were associated with better outcome, but the explained variance of the models was very small (R2=2-11%). CONCLUSIONS: The most consistently used exclusion criteria are not a major threat to the generalizability of results found in PETs. However, PETs do somewhat improve their results by exclusion of patients with minor depression and patients who used antidepressants prior to psychotherapy.

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  1. Lem R Wee N Veen T Zitman FG The generalizability of antidepressant efficacy trials to routine psychiatric out-patient practice Psychol Med 2010 21078225

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Authors
van der Lem, R., de Wever, W. W., van der Wee, N. J., van Veen, T., Cuijpers, P., & Zitman, F. G.
Affiliations
  • Vrije Universiteit Amsterdam (NL)
  • Leiden University Medical Center (NL)
ORCID
Venue
BMC Psychiatry
Publisher
Springer Science and Business Media LLC
Published
2012-11-08
Volume
12
Issue
1
Pages
192-192
ISSN
1471-244X (ISSN-L)
DOI
10.1186/1471-244x-12-192
PMC
PMC3572434
OpenAlex
W2047659593
Cited by
37
References
60
Citations by year
2026: 4 · 2025: 3 · 2024: 4 · 2022: 5 · 2021: 1 · 2020: 1 · 2019: 3 · 2018: 5 · 2017: 1 · 2016: 3 · 2015: 3 · 2014: 3 · 2012: 1
FWCI
2.55
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Psychiatry (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
  • Leiden Repository (Leiden University) (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Funders
ZonMw
Topics
  • Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
Keywords
major depressive disorder, exclusion criteria, generalizability, baseline depression severity, alcohol and drug abuse, antidepressant use, electroconvulsive therapy, routine clinical practice, symptom outcomes
MeSH terms
Adolescent, Adult, Aged, Community Mental Health Services, Depressive Disorder, Major, Major Depressive Disorder, Female, Humans, Male, Middle Aged, Netherlands, Psychotherapy, Randomized Controlled Trials as Topic, Treatment Outcome, Patient Selection

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