A Finnish Community Randomized Psychotherapy Effectiveness Study for Major Depression
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Lohja Depression Treatment Study is a randomized treatment trial which compares three
      approaches for treatment of depression:1) Interpersonal Psychotherapy (IPT), 2)
      Psychoeducational Group Treatment ( PeGT) and 3) Treatment as Usual (TAU). This Trial aims to
      test and adapt known short term treatment models for Finnish patients and circumstances.
    

Detailed description: 
      Patients having signs of depression referred to Lohja area secondary level psychiatric
      clinics were assessed to the trial. After verification the diagnosis of Major Depressive
      Disorder (MDD) they were informed of the study. Consented patients were randomized to three
      study arms.

      Baseline clinical demographics was collected. Psychotherapeutic treatment was implemented by
      specially trained therapists and the study data was collected by trained psychiatrists who
      were blinded to the therapy model patients has received.Primary outcome measure was 17-item
      Hamilton Depression Rating Scale (HAMD) and secondary outcome measures were Clinical Global
      Impression scale (CGI), Social and Occupational Functioning Assessment Scale ( SOFAS), Social
      Adaptation Scale ( Finnish translation JES) and Quality of Life assessment ( a Finnish
      validated questionnaire 15-D).The total of sick leave days and number of possible disability
      pensions in a year were assessed as well.

      Assessments were implemented at the beginning, at 1,5 month, at 3 months ( which was the end
      of active treatment of short-term psychotherapies), at 6 months and at 12 months.

      The primary assessment was planned to carry out using tests of group comparison. Sample size
      of 32 and 32 achieve 91% power to detect a clinically meaningful difference with a
      significance level (alpha) of 0.01 using two-sided two-sample t-test. Baseline differences in
      demographic variables and the depression measurement across the three treatment groups were
      tested using chi-square tests and analysis of variance.Likelihood-based inference using
      linear mixed models were employed to analyze treatment effects, focusing on the time x
      treatment interaction. Separate analyses assessed IPT-TAU and PeGT-TAU comparisons. All
      statistical analyses were performed using R. The aim of this study was to get a total of
      140-160 patients, about 50 patients on one group.The final number of patients showed to be
      134.

      The statistical calculation was intent-to-treat model with consideration to missing data,
      because in this kind of natural setting notable attrition was assumed. The training of the
      therapists and researchers and quality control during assessments was considered and
      personnel was supervised throughout the study.
    

Intervention name(s): Interpersonal Psychotherapy; Psychoeducational Group Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients were treated with IPT method, which was an active comparator vs treatment as usual; Patients were treated with PeGt method which was an active comparatos vs treatment as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment