NCT00763594

Brief Summary

The study investigates the relative efficacy of Interpersonal Psychotherapy and Brief Relational Therapy for Major Depressive Disorder. The primary hypothesis is that there will be no mean difference in efficacy between treatments, but that Brief Relational Therapy will be more efficacious for more self-critical patients and Interpersonal Psychotherapy will be more efficacious for less self-critical patients.

Trial Health

57
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Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_2 major-depressive-disorder

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_2 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

7.7 years

First QC Date

September 30, 2008

Last Update Submit

August 31, 2021

Conditions

Keywords

Major DepressionInterpersonal PsychotherapyBrief Relational TherapyOutcome research

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale, 17 item version

    The primary outcome is depression severity immediately after termination, controlling for depression severity immediately before treatment. Depression severity is measured using the 17 item version of the Hamilton Depression Rating Scale.

    Change from before treatment to after termination (16 weeks)

Secondary Outcomes (5)

  • Patient Health Questionnaire - 9

    Change from before treatment to after termination (16 weeks)

  • Inventory of Interpersonal Problems

    Change from before treatment to after termination (16 weeks)

  • Quality of Life Inventory

    Change from before treatment to after termination (16 weeks)

  • Depressive Experiences Questionnaire

    Change from before treatment to after termination (16 weeks)

  • Outcome Questionnaire - 45

    Change from before treatment to after termination (16 weeks)

Study Arms (2)

IPT

ACTIVE COMPARATOR

Interpersonal Psychotherapy for Major Depressive Disorder

Behavioral: Brief Relational TherapyBehavioral: Interpersonal Psychotherapy

BRT

EXPERIMENTAL

Brief Relational Therapy adapted for treatment of Major Depressive Disorder

Behavioral: Brief Relational Therapy

Interventions

16 weeks of psychodynamically informed and therapy alliance focussed psychotherapy adapted for treating Major Depressive Disorder.

Also known as: Relational psychotherapy, Psychodynamic therapy, PDT
BRTIPT

16 weeks of Interpersonal Psychotherapy for Major Depressive Disorder

IPT

Eligibility Criteria

Age17 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Major Depressive Disorder (DSM-IV)
  • Hamilton Depression Rating Scale (17-item version) score 20 or greater

You may not qualify if:

  • Any psychotic disorder
  • Substance abuse
  • Organic brain disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University

Linköping, SE-581 83, Sweden

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

1-phenyl-3,3-dimethyltriazeneInterpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Fredrik Falkenström, MA

    Sörmland County Council, Linköping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 1, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2016

Study Completion

December 1, 2017

Last Updated

September 8, 2021

Record last verified: 2021-08

Locations