Clinical trial NCT02150681: Mindfulness-Based Cognitive Therapy for Perinatal Women With Mood Disorders
Official title: MBCT for Perinatal Women With Mood Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Bipolar Disorder
Keywords: preconception
pregnancy
postpartum
women
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Colorado, Boulder
First posted: 2014-05-30
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Self-Rated Depression from Pretreatment to Post-treatment to 1- and 6- months post-treatment
timeFrame: Pretreatment to Post-treatment (2 months), 1 month post-treatment, and 6 months post-treatment
Secondary outcomes:
measure: Change in Observer-Rated Depression from Pretreatment to Post-treatment to 1- and 6 months post-treatment
timeFrame: Pretrreatment to Post-treatment; one-month post-treatment and 6-months post-treatment
measure: Changes in Anxiety Symptoms
timeFrame: Pretreatment to 6 months post-treatment
measure: Changes in mania symptoms
timeFrame: Pretreatment to 6 months post-treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Boulder
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of California, Los Angeles
name: David J. Miklowitz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: