Effects of pharmacotherapy and psychotherapy in depressed primary-care patients: a randomized, controlled trial including a patients' choice arm

Abstract

Mild depressive syndromes are highly prevalent among primary-care patients. Evidence-based treatment recommendations need to be derived directly from this diagnostically heterogeneous group. The primary aim was to assess the efficacy of sertraline and cognitive-behavioural group therapy for treatment of depressed primary-care patients, the secondary aim was to evaluate if receiving treatment according to free choice is associated with a better outcome than randomization to a particular treatment. We conducted a randomized, placebo-controlled, single-centre, 10-wk trial with five arms: sertraline (flexible dosages up to 200 mg/d) (n = 83); placebo (n = 83); manual-guided cognitive-behavioural group therapy (one individual session and nine group sessions per 90 min) (n = 61); guided self-help group (control condition, n = 59); and treatment with sertraline or cognitive-behavioural group therapy according to patients' choice (n = 82). From 1099 consecutively screened adult patients, 368 formed the intent-to-treat population with milder forms of depression. Primary outcome was a global efficacy measure combining z-converted Hamilton Depression Rating Scale and clinician-rated Inventory for Depressive Symptomatology scores. Sertraline was superior to placebo (p = 0.03). Outcome for guided self-help groups was worse compared to cognitive-behavioural group therapy (p = 0.002) and compared to all other treatment arms including pill placebo (secondary analyses). Outcome in the patients' choice arm was similar to that in the sertraline and cognitive-behavioural group therapy. Overall, sertraline is efficacious in primary-care patients with milder forms of depression. The superiority of cognitive-behavioural group therapy over guided self-help groups might partly be explained by 'nocebo' effects of the latter.

The Effects of Blinding on the Outcomes of Psychotherapy and Pharmacotherapy for Adult Depression: a Meta-Analysis

“…1. Thirty-five studies met inclusion criteria [2][3][4]5,6,8,[15][16][17][18]20,21,24,27,31,33,34,[40][41][42][43]45,46,[50][51][52][53][56][57][58][60][61][62]65,66]. Fig.…”

“…and three on other target groups (women with post-partum depression, multiple sclerosis patients, and stroke patients). Most studies (27) were aimed at patients with a major depressive disorder, four were aimed at unipolar mood disorders in general, and four were exclusively aimed at patients with dysthymia. Of the 41 psychotherapies that were examined, 19 were cognitive behavior therapy, eight interpersonal psychotherapy, five problem-solving therapy, four non-directive counseling, three psychodynamic therapy and two others.…”

Comparison of psychotherapies for adult depression to pill placebo control groups: a meta-analysis

“…a In all studies patients were randomized to one of three conditions: (1) psychotherapy, (2) medication or (3) placebo condition (only in the study from Hegerl et al 2010 were patients randomized to one of five conditions: CBT, medication, placebo, patient preference arm, guided self-help control).…”

The drugs don’t work? antidepressants and the current and future pharmacological management of depression

“…However, this is not to say they do not have a role, and evidence has emerged indicating sertraline is superior to placebo, and on a par with cognitive behavioural therapy (CBT) in this subgroup of patients, particularly for more chronic mild-moderate depressive disorders [Hegerl et al 2010;Cipriani et al 2011;Stewart et al 2011;Undurraga and Baldessarini, 2012] and depression scales may underestimate medication efficacy in this cohort [Isacsson and Adler, 2012]. Thus, it is not the case that antidepressants should not be prescribed to such patients, rather the risk:benefit ratio and availability of other treatments must be carefully considered beforehand.…”