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Mindfulness-Based Cognitive Therapy for Perinatal Women With Mood Disorders (MBCT)

Primary Purpose

Major Depressive Disorder, Bipolar Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based cognitive therapy
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring preconception, pregnancy, postpartum, women

Eligibility Criteria

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

Inclusion Criteria:

Eligible women for this study

  • will be planning pregnancy within the forthcoming year, are pregnant, or within one year postpartum

    • will meet criteria for at least one prior Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Revised major depressive, hypomanic, or manic episode,
    • has met lifetime Diagnostic and Statistical Manual criteria for bipolar I, II, or not otherwise specified disorder or major depressive disorder;
    • are available for group intervention scheduled meetings,
    • speak and read English,
    • age 18 or older.

Exclusion Criteria:

  • schizophrenia, schizoaffective disorder, or current psychosis;

    • organic mental disorder or pervasive developmental delay
    • current eating disorder;
    • current substance abuse or dependence;
    • imminent suicide or homicide risk;
    • history of violent behaviors toward others;
    • current thoughts of harm to an unborn or recently born child; or
    • currently experiencing a mood episode that meets full Diagnostic and Statistical Manual criteria.

Sites / Locations

  • University of California, Los Angeles
  • University of Colorado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness-based cognitive therapy

Arm Description

8 class sessions of mindfulness therapy given in a group setting, with one 2-hr session per week for 8 weeks.

Outcomes

Primary Outcome Measures

Change in Self-Rated Depression from Pretreatment to Post-treatment to 1- and 6- months post-treatment
The primary outcome is self-rated Beck Depression Inventory, II scores at the pretreatment baseline and again at Post-treatment (8 weeks), and then at 1- month and 6-months post-treatment

Secondary Outcome Measures

Change in Observer-Rated Depression from Pretreatment to Post-treatment to 1- and 6 months post-treatment
Depression will be measured using the Hamilton Rating Scale for Depression at pretreatment, post-treatment, 1 month, and 6 months after the end of mindfulness-based cognitive therapy sessions
Changes in Anxiety Symptoms
Changes in State-Trait Anxiety Inventory, State Scale from baseline to post-treatment, 1 month, and 6 months
Changes in mania symptoms
Changes in Young Mania Rating Scale scores measured at 4 times: pretreatment, post-treatment, 1 month and 6 months

Full Information

First Posted
May 27, 2014
Last Updated
May 29, 2014
Sponsor
University of California, Los Angeles
Collaborators
University of Colorado, Boulder
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1. Study Identification

Unique Protocol Identification Number
NCT02150681
Brief Title
Mindfulness-Based Cognitive Therapy for Perinatal Women With Mood Disorders
Acronym
MBCT
Official Title
MBCT for Perinatal Women With Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
University of Colorado, Boulder

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will investigate the effectiveness of mindfulness-based cognitive therapy (MBCT) for mood stabilization in perinatal women (preconception, pregnant, and postpartum) with a history of mood disorders. MBCT is a short-term group psychotherapy that has shown effectiveness in preventing depressive relapse. MBCT teaches mindfulness practices and cognitive-behavioral techniques.
Detailed Description
Approximately 10-15% of women experience depression following the birth of a child. Depression during pregnancy is also common. Women with a history of depression or bipolar disorder are at increased risk of depressive relapse or exacerbation of mood symptoms during the perinatal period. Perinatal depression is associated with a host of negative consequences that can affect the mothers, infants, and families. Women with perinatal depression may have trouble with parenting, marital quality, and employment. Children of mothers with perinatal depression may suffer intellectually or emotionally. These children are also more likely to develop a mood disorder or other psychiatric disorders throughout their lifetimes compared to children whose mothers have not been depressed. Prevention efforts during the preconception, pregnancy, and postpartum periods are of considerable public health benefit. However, perinatal women are often reluctant to start or continue psychotropic medications due to concerns about their influence on the developing fetus or nursing infant. Therefore, psychosocial treatments that modify key vulnerability factors, without medication side effects, are likely to be of strong interest to women who might otherwise remain untreated. This study will investigate the effectiveness of mindfulness-based cognitive therapy (MBCT) for mood stabilization in perinatal women (preconception, pregnant, and postpartum) with a history of mood disorders. MBCT is a short-term group psychotherapy that has shown effectiveness in preventing depressive relapse. MBCT teaches mindfulness practices and cognitive-behavioral techniques. Mindfulness is the practice of cultivating a non-judgmental awareness of internal experiences (thoughts, feelings, and body sensations) and external experiences. Cognitive-behavioral techniques focus on identifying maladaptive thoughts and behaviors before they spiral into a depressive episode. MBCT teaches observational skills and helpful techniques for responding to distorted or dysfunctional thoughts and behaviors, thereby preventing an impending depressive relapse. The investigators plan to (1) recruit 20 perinatal women at each of two sites with a history of major depressive disorder or bipolar disorder (currently in remission or partial remission), (2) ascertain their diagnoses and eligibility, (3) collect baseline data (e.g., demographic information, mood and anxiety symptoms), and (4) conduct open-trial MBCT groups with 10-12 women in each group. The investigators examine the feasibility of identifying, enrolling, and retaining perinatal women at high risk for mood episodes in an 8-week MBCT group psychotherapy. Treatment effectiveness, acceptability, and satisfaction will be assessed at the end of treatment, at 1 month post-treatment, and 6 months post-treatment. This study will contribute to the field's understanding of non-pharmacological prevention options for perinatal and postnatal women at risk for mood episode relapse. MBCT could fill an urgently needed gap in services for preconception, pregnant, and postpartum women who are at increased risk for relapse, and who wish to learn efficacious prevention skills. Given the long-term adverse consequences of untreated perinatal mood episodes for women and their children; low rates of treatment seeking; and concerns associated with pharmacological treatments, the development of a viable psychosocial intervention may have significant benefits for women, children, and society at large.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Bipolar Disorder
Keywords
preconception, pregnancy, postpartum, women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based cognitive therapy
Arm Type
Experimental
Arm Description
8 class sessions of mindfulness therapy given in a group setting, with one 2-hr session per week for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based cognitive therapy
Intervention Description
This is an 8-week treatment for women with mood disorders. The focus of sessions 1 through 4 is to establish a foundation of mindfulness practice and bringing nonjudgmental awareness to the present moment, beginning with concrete targets of attention and moves to more emotionally challenging and abstract targets (e.g., depression-specific thoughts). Participants are guided to become aware of the automatic patterns of their minds and in such moments to return attention to thoughts, feelings and body sensations. Participants engage experientially with the ways in which thoughts and emotions become engaged with rumination. In sessions 5 through 8, participants learn to extend their basic mindfulness skills to become aware of relapse risk signs and develop prevention plans.
Primary Outcome Measure Information:
Title
Change in Self-Rated Depression from Pretreatment to Post-treatment to 1- and 6- months post-treatment
Description
The primary outcome is self-rated Beck Depression Inventory, II scores at the pretreatment baseline and again at Post-treatment (8 weeks), and then at 1- month and 6-months post-treatment
Time Frame
Pretreatment to Post-treatment (2 months), 1 month post-treatment, and 6 months post-treatment
Secondary Outcome Measure Information:
Title
Change in Observer-Rated Depression from Pretreatment to Post-treatment to 1- and 6 months post-treatment
Description
Depression will be measured using the Hamilton Rating Scale for Depression at pretreatment, post-treatment, 1 month, and 6 months after the end of mindfulness-based cognitive therapy sessions
Time Frame
Pretrreatment to Post-treatment; one-month post-treatment and 6-months post-treatment
Title
Changes in Anxiety Symptoms
Description
Changes in State-Trait Anxiety Inventory, State Scale from baseline to post-treatment, 1 month, and 6 months
Time Frame
Pretreatment to 6 months post-treatment
Title
Changes in mania symptoms
Description
Changes in Young Mania Rating Scale scores measured at 4 times: pretreatment, post-treatment, 1 month and 6 months
Time Frame
Pretreatment to 6 months post-treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible women for this study will be planning pregnancy within the forthcoming year, are pregnant, or within one year postpartum will meet criteria for at least one prior Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Revised major depressive, hypomanic, or manic episode, has met lifetime Diagnostic and Statistical Manual criteria for bipolar I, II, or not otherwise specified disorder or major depressive disorder; are available for group intervention scheduled meetings, speak and read English, age 18 or older. Exclusion Criteria: schizophrenia, schizoaffective disorder, or current psychosis; organic mental disorder or pervasive developmental delay current eating disorder; current substance abuse or dependence; imminent suicide or homicide risk; history of violent behaviors toward others; current thoughts of harm to an unborn or recently born child; or currently experiencing a mood episode that meets full Diagnostic and Statistical Manual criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Miklowitz, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of Colorado
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309-0345
Country
United States

12. IPD Sharing Statement

Links:
URL
http://albertsfoundation.org
Description
This organization, which funded this research, provides considerable information on bipolar disorder and mindfulness treatments.

Learn more about this trial

Mindfulness-Based Cognitive Therapy for Perinatal Women With Mood Disorders

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