DepressionNCT01453114
Cognitive-Behavioral Therapy (CBT) in Women Discontinuing Antidepressant for Pregnancy
A study testing Cognitive Behavioral Therapy in people with Depression and Postpartum Depression, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum Depression, Antenatal Depression
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jul 2012
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Cognitive-Behavioral Therapy 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.
Read the detailed 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.
- Conditions
- Depression, Postpartum Depression, Antenatal Depression
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Cognitive Behavioral Therapy, CBT, relapse, postpartum depression, depression recurrence, depression relapse
- Medical subject headings
- Depression, Depression, Postpartum, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT
CBT is administered for 12 sessions over the period of 16 weeks, followed by optional monthly sessions.
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | Experimental | Cognitive Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
MDE diagnosed using the mood module of the Mini-International Neuropsychiatric Interview (MINI)
Measured: Within a year of study entry
Secondary outcomes (1)
Depression severity
Depression severity is determined using the Montgomery-Asberg Depression Rating Scale (MADRS).
Measured: throughout the 52 weeks of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startNov 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee S. Cohen, MD, Massachusetts General Hospital
- Investigators
- Lee S Cohen, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453114
- Sponsor's protocol ID
- 2008P002161
- Status last verified
- Apr 2015
- First submitted
- 12 Oct 2011
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral Therapy in Women Discontinuing Antidepressant for Pregnancy
- ClinicalTrials.gov ID
- NCT01453114
- Acronym / sponsor ID
- 2008P002161
- Conditions
- Depression, Postpartum Depression, Antenatal Depression
- Keywords
- Cognitive Behavioral Therapy, CBT, relapse, postpartum depression, depression recurrence, depression relapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Experimental | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBTCBT is administered for 12 sessions over the period of 16 weeks, followed by optional monthly sessions. | Behavioural | Psychotherapy |
Primary outcome
Relapse
Time frame: Within a year of study entry
MDE diagnosed using the mood module of the Mini-International Neuropsychiatric Interview (MINI)
1 secondary outcome
Depression severity
Time frame: throughout the 52 weeks of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee S Cohen, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Depression and Postpartum Depression, run by Massachusetts General Hospital at 1 site 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 6 inclusion and 7 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Relapse (time frame: Within a year of study entry). 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 7 Apr 2015.