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A Finnish Community Randomized Psychotherapy Effectiveness Study for Major Depression

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ClinicalTrials.gov Identifier: NCT02314767
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
HSaloheimo, Helsinki University Central Hospital

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Behavioral: Interpersonal Psychotherapy Behavioral: Psychoeducational Group Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Finnish Community Randomized Psychotherapy Effectiveness Study for Major Depression
Study Start Date : February 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Interpersonal Psychotherapy
Patients were treated with IPT method, which was an active comparator vs treatment as usual

Behavioral: Psychoeducational Group Therapy
Patients were treated with PeGt method which was an active comparatos vs treatment as usual

Active Comparator: 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.
Behavioral: Interpersonal Psychotherapy
Patients were treated with IPT method, which was an active comparator vs treatment as usual

Behavioral: Psychoeducational Group Therapy
Patients were treated with PeGt method which was an active comparatos vs treatment as usual

No Intervention: 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



Primary Outcome Measures :
  1. Change from baseline Hamilton Rating Scale for Depression at 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change from baseline Clinical Global Impression, severity and change at 12 months [ Time Frame: 12 months ]
  2. Change from baseline Social and Occupational Functioning Assessment Scale at 12 months [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314767


Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Study Director: Heikki O Katila, MD Ph.D. Helsinki University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: HSaloheimo, MD Psychiatrist, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02314767     History of Changes
Other Study ID Numbers: Lohja Depression Treatment
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders