Mindfulness-Based Cognitive Therapy for Perinatal Women With Mood Disorders

NCT02150681 | Completed Phase 1

• 1 other identifier: 11-003212
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Disorder; Bipolar Disorder

Keywords

preconception; pregnancy; postpartum; women

Outcome Measures

Primary Outcomes (1)

• 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

  Pretreatment to Post-treatment (2 months), 1 month post-treatment, and 6 months post-treatment

Secondary Outcomes (3)

• Change in Observer-Rated Depression from Pretreatment to Post-treatment to 1- and 6 months post-treatment

  Pretrreatment to Post-treatment; one-month post-treatment and 6-months post-treatment

• Changes in Anxiety Symptoms

  Pretreatment to 6 months post-treatment

• Changes in mania symptoms

  Pretreatment to 6 months post-treatment

Study Arms (1)

Mindfulness-based cognitive therapy

EXPERIMENTAL

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

Behavioral: Mindfulness-based cognitive therapy

Interventions

Mindfulness-based cognitive therapy BEHAVIORAL

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.

Mindfulness-based cognitive therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Colorado, Boulder: collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

University of Colorado

Boulder, Colorado, 80309-0345, United States

Location

Related Links

• This organization, which funded this research, provides considerable information on bipolar disorder and mindfulness treatments.

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• David J. Miklowitz, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 30, 2014

Record last verified: 2014-05

Locations

US (2)