- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02314767
A Finnish Community Randomized Psychotherapy Effectiveness Study for Major Depression
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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
|
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.
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline Hamilton Rating Scale for Depression at 12 months
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline Clinical Global Impression, severity and change at 12 months
Time Frame: 12 months
|
12 months
|
Change from baseline Social and Occupational Functioning Assessment Scale at 12 months
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Investigators
- Study Director: Heikki O Katila, MD Ph.D., University of Helsinki
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lohja Depression Treatment
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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