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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

Tracking Information
First Submitted Date  ICMJE December 4, 2014
First Posted Date  ICMJE December 11, 2014
Last Update Posted Date December 11, 2014
Study Start Date  ICMJE February 2004
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
Change from baseline Hamilton Rating Scale for Depression at 12 months [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
  • Change from baseline Clinical Global Impression, severity and change at 12 months [ Time Frame: 12 months ]
  • Change from baseline Social and Occupational Functioning Assessment Scale at 12 months [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Finnish Community Randomized Psychotherapy Effectiveness Study for Major Depression
Official Title  ICMJE A Finnish Community Randomized Psychotherapy Effectiveness Study for Major Depression
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Interpersonal Psychotherapy
    • Behavioral: Psychoeducational Group Therapy
  • 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.
    Interventions:
    • Behavioral: Interpersonal Psychotherapy
    • Behavioral: Psychoeducational Group Therapy
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2014)
134
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02314767
Other Study ID Numbers  ICMJE Lohja Depression Treatment
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party HSaloheimo, Helsinki University Central Hospital
Study Sponsor  ICMJE Helsinki University Central Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Heikki O Katila, MD Ph.D. University of Helsinki
PRS Account Helsinki University Central Hospital
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP