OBJECTIVES: * To assess the relative effectiveness of two established forms of short-term psychotherapy (psychodynamic and cognitive-behavioural) for depression that have not yet been compared. * To assess whether venlafaxine (Efexor) addition improves the effectiveness of psychotherapeutic treatment in patients with early treatment resistance and in patients with severe major depression. * To assess whether clinical predictors can be identified that distinguish patients that may benefit from either of these treatments in particular. Characteristics include demographic variables, depression characteristics, co-morbid anxiety symptoms, somatic symptoms, and personality.
METHODS: Adult outpatients aged 18-65 years referred to Mentrum Mental Health Institute with a DSM IV-defined depressive disorder (unipolar depression, dysthymia,a or double depression). Exclusion criteria: psychotic symptoms, bipolar disorder, or suicidal behaviour. Patients with mild-to-moderately severe depression (Hamilton Depression Rating Scale [HDRS] 12-24) will receive either short psychodynamic supportive psychotherapy (SPSP) or cognitive behavioural therapy (CBT), two established (but never before compared) treatment approaches. Venlafaxine is added in case of early treatment non-response (less then 25% improvement after ten sessions). Severely depressed patients (HDRS >24) will be offered combined therapy from the start; venlafaxine plus one of the two psychotherapy conditions. Venlafaxine is prescribed according to protocol, with the dose depending on clinician s judgement and a depression severity index. In both conditions (SPSP and CBT), 16 sessions of 45 minutes each will be given during a period of approximately six months. Measurements will take place at intake, after ten sessions (10-14 weeks treatment), after 16 sessions (6-7 months), and at 12 months after start of treatment. Measurements include the 17-item HDRS, CIDI, Beck Anxiety Index, Inventory of Depressive Symptoms, a self-report questionnaire for the diagnosis of personality disorders (Vragenlijst Kenmerken Persoonlijkheid; derived from the International Personality Disorder Examination), Luborsky index, Outcome Questionnaire (OQ-45), TIC-P, EuroQol, Visual Analogue Scale and subscale somatic complaints of Symptom Checklist-90 (for measurement of pain), and instruments on cognitions and attitudes toward (psycho)therapy. Aspecific factors, mainly working-alliance, will be measured by means of an interview and a self-report questionnaire (Helping Alliance Questionnaire).
The study is divided into four phases, during which the above-mentioned instruments will be administered. From the start, a distinction is made between mild and moderate depression. Beginning at phase 2, response (>25% HDRS reduction) is taken into account in addition to this distinction. Phase 1: Intake measurements and patient inclusion (informed consent). * Mild-to-moderate depression: random allocation to either SPSP or CBT. * Severe depression (HDRS >24): SPSP/CBT plus venlafaxine. Phase 1 terminates at ten sessions in about 10-14 weeks. Phase 2: Measurement after ten sessions. * Mild-to-moderate depression: o if >25% HDRS reduction, treatment is continued as in phase 1. o if <25% HDRS reduction, venlafaxine is added. * Severe depression: o if > 25% HDRS reduction: continuation of combined treatment as in phase 1. o if not responding (<25% HDRS reduction): medication switch. Phases 1 and 2 together comprise approximately 6 months. In phase 1, ten weekly sessions will be administered; in phase 2, six remaining sessions will be given on a biweekly basis. Phase 3 covers the measurement taken at treatment termination (approximately 6 months). Phase 4 covers the measurement taken at 12 months. No control condition is used with placebo prescription. |
