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Major Depressive DisorderPhase 1MBCTNCT02150681

Mindfulness-Based Cognitive Therapy for Perinatal Women With Mood Disorders

A Phase 1 study testing Mindfulness-based cognitive therapy in people with Major Depressive Disorder and Bipolar Disorder, run by University of California, Los Angeles at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Major Depressive Disorder, Bipolar Disorder
What is being tested?
Mindfulness-based cognitive therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
2 sitesUnited States
Study dates
Oct 2012to Oct 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Colorado

    Boulder, Colorado, 80309-0345

  • University of California, Los Angeles

    Los Angeles, California, 90024

Other trials in United States

About this study

Official title: MBCT for Perinatal Women With Mood Disorders

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.

Read the 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.

Being tested
Mindfulness-based cognitive therapy
Keywords
preconception, pregnancy, postpartum, women
Medical subject headings
Depressive Disorder, Major, Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-based cognitive therapyBehavioural

    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.

Study groups in NCT02150681
Study groupRoleWhat they receive
Mindfulness-based cognitive therapyExperimental8 class sessions of mindfulness therapy given in a group setting, with one 2-hr session per week for 8 weeks.
Receives: Behavioral: Mindfulness-based cognitive therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (3)
  1. 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

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

  2. Changes in Anxiety Symptoms

    Changes in State-Trait Anxiety Inventory, State Scale from baseline to post-treatment, 1 month, and 6 months

    Measured: Pretreatment to 6 months post-treatment

  3. Changes in mania symptoms

    Changes in Young Mania Rating Scale scores measured at 4 times: pretreatment, post-treatment, 1 month and 6 months

    Measured: Pretreatment to 6 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2014 (estimated)
  2. Study startOct 2012
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02150681
Sponsor's protocol ID
11-003212
Acronym
MBCT
Status last verified
May 2014
First submitted
27 May 2014
Last updated
30 May 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mindfulness-based cognitive therapy in people with Major Depressive Disorder and Bipolar Disorder, run by University of California, Los Angeles at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Self-Rated Depression from Pretreatment to Post-treatment to 1- and 6- months post-treatment (time frame: Pretreatment to Post-treatment (2 months), 1 month post-treatment, and 6 months post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2014.

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