NCT02314767

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2004

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

3.2 years

First QC Date

December 4, 2014

Last Update Submit

December 9, 2014

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Hamilton Rating Scale for Depression at 12 months

    12 months

Secondary Outcomes (2)

  • Change from baseline Clinical Global Impression, severity and change at 12 months

    12 months

  • Change from baseline Social and Occupational Functioning Assessment Scale at 12 months

    12 months

Study Arms (3)

Interpersonal Psychotherapy

ACTIVE COMPARATOR

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 PsychotherapyBehavioral: Psychoeducational Group Therapy

Psychoeducational Group Therapy

ACTIVE COMPARATOR

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 PsychotherapyBehavioral: Psychoeducational Group Therapy

Treatment as Usual

NO INTERVENTION

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

Interventions

Interpersonal PsychotherapyBEHAVIORAL

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

Interpersonal PsychotherapyPsychoeducational Group Therapy
Psychoeducational Group TherapyBEHAVIORAL

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

Interpersonal PsychotherapyPsychoeducational Group Therapy

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Major Depressive Disorder - diagnosed
  • Comorbid anxiety disorders

You may not qualify if:

  • Psychosis
  • Suicidal patients
  • Serious acute somatic illness
  • Inability to read and write
  • alcohol dependence or use of illicit drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27153942DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Heikki O Katila, MD Ph.D.

    University of Helsinki

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Psychiatrist

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 11, 2014

Study Start

February 1, 2004

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

December 11, 2014

Record last verified: 2014-12