Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01453114
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Completed
Phase N/A
Start date November 2008
Completion date July 2012

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A