Abstract
BackgroundTreatment 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.MethodsWe 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.ResultsWe 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%).ConclusionsThe 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.
Highlights
Treatment guidelines for major depressive disorder (MDD) are based on results from randomized clinical trials, among others in psychotherapy efficacy trials
Of the remaining 27 psychotherapy efficacy trials (PETs), seven were excluded for the following reasons: in one PET the psychotherapeutic intervention appeared to include a prominent role for the spouse of the patients [21]; in another, the use of in- and exclusion criteria was mentioned but not made explicit [22] ; five PETs were excluded as they used the same datasets as other studies already part of our review [23] [24] [25] [26] [27]
Comparison with previous research on effects of exclusion criteria on symptom outcome We found that the exclusion of patients who are ‘not meeting the baseline severity threshold of HAM-D ≤14’ is associated with a smaller proportion of patients who reach remission, while in our previous research in the same sample we found a positive association between exclusion of patients with a baseline severity of HAM-D≤17 and probability of remission [7]
Summary
Treatment guidelines for major depressive disorder (MDD) are based on results from randomized clinical trials, among others in psychotherapy efficacy trials Patients in these trials differ from routine practice patients since trials use stringent criteria for patient selection. In trials of antidepressant treatment of major depression (MDD), a fairly consistent set of exclusion criteria is used [2] Based on this set of criteria, we and others found that only 12-34% of the patients who received treatment for MDD in routine outpatient psychiatric care settings and fee-for-service private practice were eligible for participation in an antidepressant efficacy trial (AET) [1,3] [7]. The AET exclusion criteria had a limited influence on treatment outcome
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