NCT00461279

Brief Summary

In this study, the focus is on an individual's attachment security and its relation to treatment outcome in Major Depression.Adult attachment reflects how one seeks psychological and physical proximity to others for security and protection in times of stress. Researchers typically define four types of attachment security: one secure and three insecure (preoccupied, dismissing, and fearful). Adults with Major Depressive Disorder (MDD) will be randomly assigned to either Interpersonal Psychotherapy (IPT) or to Cognitive Behavior Therapy (CBT). The expectation is that adults with avoidant attachment styles will respond better to CBT, and adults with preoccupied attachment styles will respond better to IPT. Also, in comparison to CBT, outcome in IPT is hypothesized to be more closely related to change in attachment.

Trial Health

87
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 Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

3.5 years

First QC Date

April 13, 2007

Last Update Submit

December 2, 2011

Conditions

Keywords

attachmentdepressionIPTCBTpharmacotherapy

Outcome Measures

Primary Outcomes (2)

  • HAMD

    baseline and completion

  • BDI

    baseline and completion

Study Arms (2)

1

OTHER
Behavioral: Cognitive Behavior Therapy

2

OTHER
Behavioral: Interpersonal Psychotherapy

Interventions

Reframing and understanding cognitions of depression

1

Established psychotherapy for depression

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • or older
  • meet the criteria for DSM-IV diagnosis of MDD based on the Structured Interview for DSM-IV, Axis I disorders (SCID-I; First et al., 1995)
  • score \> 16 on the 17-item HRSD (Hamilton, 1960).

You may not qualify if:

  • Bipolar Disorder
  • Schizoaffective Disorder
  • Schizophrenia
  • Substance Abuse
  • Borderline or Antisocial Personality Disorder
  • Organic Brain Syndrome
  • ECT within the past 6 months
  • concurrent active medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Cognitive Behavioral TherapyInterpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Carolina McBride, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Carolina McBride, C.Psych

Study Record Dates

First Submitted

April 13, 2007

First Posted

April 17, 2007

Study Start

August 1, 2006

Primary Completion

February 1, 2010

Study Completion

March 1, 2010

Last Updated

December 6, 2011

Record last verified: 2011-12

Locations