A Finnish Community Randomized Psychotherapy Effectiveness Study for Major Depression

Depressive Disorder, Major Clinical Trial

Official title:

A Finnish Community Randomized Psychotherapy Effectiveness Study for Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314767
• Other study ID #: Lohja Depression Treatment
• Status: Completed
• Phase: N/A
• First received: December 4, 2014
• Last updated: December 9, 2014
• Start date: February 2004
• Est. completion date: April 2007

Study information

• Verified date: December 2014
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland HUS Lohja Director of Hospital Area
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Major Depressive Disorder - diagnosed

• Comorbid anxiety disorders

Exclusion Criteria:

• Psychosis

• Suicidal patients

• Serious acute somatic illness

• Inability to read and write

• alcohol dependence or use of illicit drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Behavioral:
• Interpersonal Psychotherapy
Patients were treated with IPT method, which was an active comparator vs treatment as usual
• Psychoeducational Group Therapy
Patients were treated with PeGt method which was an active comparatos vs treatment as usual

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Hamilton Rating Scale for Depression at 12 months		12 months	No
Secondary	Change from baseline Clinical Global Impression, severity and change at 12 months		12 months	No
Secondary	Change from baseline Social and Occupational Functioning Assessment Scale at 12 months		12 months	No