A Finnish Community Randomized Psychotherapy Effectiveness Study for Major Depression

NCT ID: NCT02314767

Last Updated: 2014-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2007-04-30

Brief 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.

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interpersonal Psychotherapy

Interpersonal Psychotherapy treatment for MDD patients was implemented with antidepressant pharmacotherapy by national Quidelines for the treatment of Patients with depression. Intervention:Interpersonal psychotherapy as ADD-on method. Outcome was compared with patients in treatment as usual group.

Group Type: ACTIVE_COMPARATOR

Interpersonal Psychotherapy

Intervention Type: BEHAVIORAL

Patients were treated with IPT method, which was an active comparator vs treatment as usual

Psychoeducational Group Therapy

Intervention Type: BEHAVIORAL

Patients were treated with PeGt method which was an active comparatos vs treatment as usual

Psychoeducational Group Therapy

Psychoeducational Group Therapy arm for MDD patients with antidepressant pharmacotherapy by national Quidelines for the treatment of Patients with depression. Intervention: Psychoeducational Group Treatment as ADD-on method.

Group Type: ACTIVE_COMPARATOR

Interpersonal Psychotherapy

Intervention Type: BEHAVIORAL

Patients were treated with IPT method, which was an active comparator vs treatment as usual

Psychoeducational Group Therapy

Intervention Type: BEHAVIORAL

Patients were treated with PeGt method which was an active comparatos vs treatment as usual

Treatment as Usual

Treatment as usual ( consisting of supportive psychodynamic-oriented treatment) with antidepressant pharmacotherapy by national Quidelines for the treatment of Patients with depression

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Interpersonal Psychotherapy

Patients were treated with IPT method, which was an active comparator vs treatment as usual

Intervention Type: BEHAVIORAL

Psychoeducational Group Therapy

Patients were treated with PeGt method which was an active comparatos vs treatment as usual

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

HSaloheimo

MD Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heikki O Katila, MD Ph.D.

Role: STUDY_DIRECTOR

University of Helsinki

References

Saloheimo HP, Markowitz J, Saloheimo TH, Laitinen JJ, Sundell J, Huttunen MO, A Aro T, Mikkonen TN, O Katila H. Psychotherapy effectiveness for major depression: a randomized trial in a Finnish community. BMC Psychiatry. 2016 May 6;16:131. doi: 10.1186/s12888-016-0838-1.

Reference Type: DERIVED

PMID: 27153942 (View on PubMed)

Other Identifiers

Lohja Depression Treatment

Identifier Type: -

Identifier Source: org_study_id