Do treatments work for depression in real world? Jl of affective disorder (online first sept 2012)

08.10.12

Treatment guidelines  are based on RCTs. However, do efficacy ( effect under trial conditions) always translate  to effectiveness (effect under real word conditions)? In real life patients participate in treatment selection. Patients seeking treatment in real life could be different from those recruited in trials. Issues of generalisability often limit the use of  information from RCTs.Consequently, there have been calls for research to address effectiveness rather than efficacy . Many studies have shown that “treatment as usual” retains most of the benefits in lab conditions. (Barkham et al., 2008; Cuffel et al., 2003; Minami et al., 2008; Shadish et al., 2000; Stiles et al., 2008; van der Lem et al., 2011).

This study examined the effectiveness of IPT and CT (each alone and combined with antidepressant medication) in patients with a well-classified of MDD episode actively seeking treatment in an outpatient treatment facility in Netherlands.Patients were given the choice of their preferred treatment,i.e. participants were not randomised.The only inclusion criterion was a primary diagnosis of non- delusional major depressive disorder (MDD) determined with the Structured Clinical Interview for DSM-IV Axis I. The only exclusion criteria at entry were primary diagnoses other than MDD (e.g., bipolar disorder, psychotic disorder, or substance abuse) and high acute suicide risk. patients were followed for a 26-week period.

Experienced therapists delivered CBT or IPT.Sessions were held for 50 min weekly with the possibility of maintenance sessions following the acute phase treatment.  Participants in the medication plus CBT or medication plus IPT arm generally received an SSRI. In case of SSRI non-response in the current episode, participants were prescribed another SSRI, venlafaxine or a tricyclic agent augmented with lithium in case of subsequent non-response.

Measures were administered prior to treatment and at 8, 16, and 26 weeks. The main outcome variable was the Beck Depression Inventory.Response was defined a priori as a decrease of at least 10 points from baseline BDI-score, whereas remission was defined as an absolute BDI-score of 10 points or less.There were 174 participants.

Findings: Clinical improvement after the first 8 weeks of treatment was modest, yielding remission in 20% of participants. However, BDI scores decreased steadily thereafter, with an overall remission rate at 26 weeks in the sample of 35% .The researchers observed no difference in overall effectiveness among treatments either as monotherapies or in combination. BDI-scores in patients receiving CT alone, although ending around the same mean, decreased faster than these scores in patients receiving CT combined with antidepressant medication.

Limitations:  Modest sample size may have obscured significant differences in effectiveness between treatments. 35% of eligible patients referred to the mood disorders treatment program chose not to participate in the study which may limit generalization. Substantial number of participants were lost to follow-up.    Participants were not randomized. Treatment choice depended on participants’ preferences, which may have been influenced by many sources.

It has to be noted that more than a third of participants  suffered from chronic MDD.

This study shows that treatments for depression ( pharmacotherapy as well as psychological interventions delivered by very experienced therapists, 13 plus sessions) are effective in real world. However the remission was achieved only in one third by 26 weeks. This reveal the challenges of treating depression.

The clinical effectiveness of evidence-based interventions for depression: A pragmatic trial in routine practice.

Peeters F, Huibers M, Roelofs J, van Breukelen G, Hollon SD, Markowitz JC, van Os J, Arntz A J Affect Disord. 2012 Sep 14. pii: S0165-0327(12)00591-5. doi: 10.1016/j.jad.2012.08.022

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