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Attachment Security as Mediator and Moderator of Outcome in Major Depression

Primary Purpose

Major Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavior Therapy
Interpersonal Psychotherapy
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring attachment, depression, IPT, CBT, pharmacotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 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).

Exclusion Criteria:

  • 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

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

HAMD
BDI

Secondary Outcome Measures

Full Information

First Posted
April 13, 2007
Last Updated
December 2, 2011
Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Mental Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00461279
Brief Title
Attachment Security as Mediator and Moderator of Outcome in Major Depression
Official Title
Attachment Security as Mediator and Moderator of Outcome in Major Depression Following Interpersonal Therapy and Cognitive Behavior Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Mental Health Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
At the current rate of increase, Major Depression, it will be the 2nd most disabling condition in the world by 2020, behind heart disease. There are now a number of effective treatments for depression. However, a significant number of people either partially recover from their depression after a course of treatment, or do not recover at all. For example, between 30% and 50% of depressed individuals taking an antidepressant are partially or totally resistant to the treatment, and more than ½ of patients in psychotherapy never achieve full remission. The goal of treatment of major depression should always be full remission. Not achieving full remission from depression is problematic as lingering symptoms are a powerful predictor of relapse. One problem may be in the type of treatment that is offered to the individual. We know little about which clients benefit from which type of treatments and which clients do poorly. One individual may respond better to one type of treatment, while another individual may respond better to another type of treatment. The accurate identification of how an individual's characteristics interact with the type of treatment offered will help us match patients to the best-suited treatment for them, so we can optimize outcome. One characteristic that may be related to treatment outcome is adult attachment security. 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). Secure adults have a good sense of self-worth and are comfortable with intimacy. Preoccupied adults have an exaggerated desire for closeness and a heightened concern about rejection. Dismissing adults deny the value of close relationships and instead value self-reliance. Finally, fearful adults have a very negative sense of self and avoid intimacy because they fear rejection. Secure attachment has been linked to positive interpersonal relationships and psychological health and insecure attachment has been linked to overall psychological distress. In this study, I focus on attachment security and its relation to treatment outcome. 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. The power of this study lies in its considered integration of three important issues at the forefront of mental health today: MDD, attachment, and treatment. MDD is a leading cause of disability worldwide and theoretically and empirically related to attachment. Attachment theory is a primary paradigm in the developmental, social/personality, and clinical literatures, and forms the theoretical cornerstone for IPT. IPT and CBT, while successful to a degree, fail or partially fail in many cases. Successful outcome in IPT depends on successfully improving a patient's attachment representations; this is not the case in CBT where change in depression is associated with change in cognition. The fact that these treatments represent contrasting approaches in the context of attachment, affords us a unique opportunity to investigate the relationships between attachment and treatment outcome for two distinct treatments, and investigate whether an individual's attachment security interacts with the type of treatment offered to yield a better response for one type of treatment versus another. This research could have a major impact on tailoring treatment to patient characteristics to optimize treatment for major depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
attachment, depression, IPT, CBT, pharmacotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Title
2
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Intervention Description
Reframing and understanding cognitions of depression
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Intervention Description
Established psychotherapy for depression
Primary Outcome Measure Information:
Title
HAMD
Time Frame
baseline and completion
Title
BDI
Time Frame
baseline and completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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). Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina McBride, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.camh.net/research
Description
Information about research at the Centre for Addiction and Mental Health

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Attachment Security as Mediator and Moderator of Outcome in Major Depression

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