A Phase 1 interventional study of Mindfulness-based cognitive therapy in Major Depressive Disorder and Bipolar Disorder, sponsored by University of California, Los Angeles. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-30.
Sponsored by University of California, Los Angeles · Phase 1, Interventional, and Treatment
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.
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 39 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
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Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
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Eligible women for this study
will be planning pregnancy within the forthcoming year, are pregnant, or within one year postpartum
Exclusion Criteria:
schizophrenia, schizoaffective disorder, or current psychosis;
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
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.
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
Time frame: Pretreatment to Post-treatment (2 months), 1 month post-treatment, and 6 months post-treatment
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
Time frame: Pretrreatment to Post-treatment; one-month post-treatment and 6-months post-treatment
Changes in Anxiety Symptoms
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
Changes in mania symptoms
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
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles