Cognitive-Behavioral Therapy (CBT) in Women Discontinuing Antidepressant for Pregnancy
Cognitive-Behavioral Therapy (CBT) in Women Discontinuing Antidepressant for Pregnancy
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.
The current study is a small year-long pilot to collect data for a planned larger, randomized
 control trial in the future. The current protocol focuses on modifying a Cognitive-Behavioral
 Therapy (CBT) recurrence prevention protocol for the study population, finalizing a therapist
 training manual, finalizing therapist adherence and competence scales, and fine tuning
 research procedures for recruitment and retention of subjects. This phase will involve
 enrolling 20 subjects in order to have at least 12 subjects receive CBT treatment for 12
 weeks with assessments conducted bimonthly. The subjects will have the option of having
 additional monthly "booster" CBT sessions. Independent Assessments by HRC-approved study
 staff and interviews with study psychiatrists will occur at 16 weeks, 24 weeks, 36 weeks, and
 1 year after study initiation. Participants will be offered the opportunity to speak with a
 study psychiatrist at every visit.

 The primary outcome measure is rate of recurrence and/or re-initiation of antidepressant
 treatment up to 12 months post-randomization. The study end point of procedures is 12 weeks
 after baseline; the study end point for follow-up assessments is one year after treatment.

 At the point of enrollment, subjects will have reviewed risks and benefits of perinatal
 depression treatment in a consultation with a non-study psychiatrist in the MGH Center for
 Women's Mental Health (CWMH) program and in collaboration with the subject's primary
 psychiatrist, and decided to discontinue AD treatment.

 The potential subject will then undergo a preliminary phone screening with a CWMH research
 coordinator where basic eligibility criteria are reviewed. If the potential subject is
 interested, she will be scheduled for a baseline study visit conducted by the PIs or another
 study clinician. After an explanation of study procedures, written, informed consent will be
 obtained. This will occur prior to execution of any study assessments or procedures.

 After consent is obtained, the clinician will conduct a structured clinical interview using
 the MINI and HRC-approved study staff will complete study assessments. If the potential
 subject continues to be interested in participating in the study and remains eligible, she
 will meet with a study psychiatrist who will instruct her on how to begin the taper of her
 antidepressant, if she has not already started to taper. The subject will then meet with the
 clinician who will administer the CBT treatment for the first session

 After the 12 weeks have passed, subjects will be asked to complete assessments at 16 weeks,
 24 weeks, 36 weeks, and 1 year after beginning the study, and will be able to choose to
 continue monthly booster sessions of CBT-PR. Subjects will also be offered the opportunity to
 meet with study psychiatrists every booster session. Visits with the study psychiatrist will
 be arranged at the discretion of the study psychologist and/or upon participant request. An
 optional qualitative interview will be conducted by study staff after completion of the acute
 treatment phase in order to obtain feedback on the intervention.

 Participants who experience a relapse of depressive symptoms during study participation will
 have the option of remaining in the study and continuing to receive CBT treatment regardless
 of decisions regarding antidepressant treatment. Additionally, the investigators will ask
 patients who experience a relapse to complete a questionnaire regarding the course of relapse
 and their treatment decisions at one year after study enrollment. This questionnaire can be
 completed over the phone or at home and returned by mail.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  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).