Cognitive-Behavioral Therapy (CBT) in Women Discontinuing Antidepressant for Pregnancy

NCT01453114 | Completed

• 1 other identifier: 2008P002161
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of this study is to adapt a cognitive behavioral prevention of recurrence treatment (CBT-PR) for women with a history of recurrent major depressive disorder who decide to discontinue their maintenance anti-depressant (AD) treatment for pregnancy.

Conditions

Depression; Postpartum Depression; Antenatal Depression

Keywords

Cognitive Behavioral Therapy; CBT; relapse; postpartum depression; depression recurrence; depression relapse

Outcome Measures

Primary Outcomes (1)

• Relapse

  MDE diagnosed using the mood module of the Mini-International Neuropsychiatric Interview (MINI)

  Within a year of study entry

Secondary Outcomes (1)

• Depression severity

  throughout the 52 weeks of the study

Study Arms (1)

Psychotherapy

EXPERIMENTAL

Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

CBT is administered for 12 sessions over the period of 16 weeks, followed by optional monthly sessions.

Also known as: CBT

Psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will include women 18 years and older who are either planning pregnancy or already pregnant and meet the following criteria:
• Currently meet criteria for stable remission from depression (defined as a baseline score of ≤ 9 on the Hamilton Rating Scale for Depression (HRSD) and documented clinical remission for a minimum of six months prior to randomization)
• Current or recent treatment with an antidepressant (stable dosage for at least the last four weeks)
• Have a history of a major depressive episode
• Decide to discontinue antidepressant medication for pregnancy
• Currently receive ongoing psychiatric care provided by a physician outside the MGH Center for Women's Mental Health, and written, informed consent.

You may not qualify if:

• Significant risk for self-harm or harm to others
• Psychotic symptoms
• Meeting criteria for a primary SCID-I/P diagnosis of schizophrenia, bipolar disorder, an active eating disorder, dementia, delirium, or other cognitive disorder
• Presence of an active substance and/or alcohol abuse disorder within six months prior to screening visit
• Current use of mood stabilizers, antipsychotics or antiepileptics
• Have received cognitive-behavioral or interpersonal therapy within the last year
• Diagnosed with a medical disorder that has a known association with depressive symptoms (e. g. thyroid disorder).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression; Depression, Postpartum; Recurrence

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lee S Cohen, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Perinatal and Reproductive Psychiatry Clinical Research Program

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 17, 2011
• Study Start: November 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

US (1)