DepressionNCT00292903
Evaluating the Effectiveness of Brief Interpersonal Psychotherapy for Pregnant Women With Depression
A study testing Brief interpersonal psychotherapy and Facilitated referral for treatment as usual in people with Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will compare the effectiveness of brief interpersonal psychotherapy versus standard treatment for pregnant women with depression. 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
- What is being tested?
- Brief interpersonal psychotherapy and Facilitated referral for treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Dec 2007
- 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
- Between 8 and 32 weeks of gestation at time of study entry
- A score above 12 on the Edinburgh Postnatal Depression Scale
- Speaks English
- Resides in the Pittsburgh, PA, area
- Access to a household telephone
Who cannot join
- Currently receiving treatment for depression (i.e., medication or psychotherapy)
- History of a prior manic episode
- Alcohol or drug abuse or dependence within 6 months of study entry
- Psychotic disorder or organic mental disorder
- Suicidal, homicidal, or requires hospitalization
- Severe sexual and/or physical aggression in relationship with partner or husband
- Significant medical illness such as epilepsy, autoimmune disorder, liver dysfunction, or unstable endocrine disease
- Severe cognitive deficits that would prevent treatment with psychotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Culturally Relevant Brief Interpersonal Psychotherapy (IPT-B) for Perinatal Depression
This study will compare the effectiveness of brief interpersonal psychotherapy versus standard treatment for pregnant women with depression.
Read the detailed description
Depression is a serious condition affecting millions of people each year. In fact, it is estimated that approximately one in every four women will be treated for a mood disorder, such as depression, at some point in her life. As effective treatment options continue to develop, many women diagnosed with depression are able to resume normal lives and may choose to become pregnant. Also, some women become depressed when pregnant. Interpersonal psychotherapy involves treating psychological difficulties by analyzing problems, talking about possible solutions, and learning more helpful ways of thinking and acting. Brief interpersonal psychotherapy (IPT-B) is a well-tested psychotherapy for depression that has been shortened and modified. The purpose of this study is to evaluate the effectiveness of IPT-B to reduce depressive symptoms in women during pregnancy and to prevent the continuation or recurrence of their depression postpartum.
Participants in this open-label study will be randomly assigned to receive either IPT-B or a facilitated referral for treatment as usual (F-TAU) at an outpatient clinic or community mental health center. Participants assigned to IPT-B will be scheduled to attend eight treatment sessions along with their prenatal clinic visits within a 16-week period. Each treatment session will begin with a brief 1-minute evaluation to assess participants' level of depression and will end with a brief evaluation of the session. Participants will attend follow-up sessions every 2 weeks until 3 months postpartum and then monthly until 6 months postpartum. These sessions will include evaluation of participants' level of depression, identification of any difficulties or problems that participants may be experiencing, and review of how to manage these problems using skills learned during treatment. Participants assigned to receive F-TAU will be provided with verbal and written information regarding their depressive symptoms. They will also receive a referral for treatment at a behavioral health clinic. Participants receiving F-TAU will be assessed via telephone at Weeks 6 and 12. All participants will be assessed via telephone at Months 2 and 6 postpartum to measure their level of depression.
- Conditions
- Depression
- Being tested
- Brief interpersonal psychotherapy, Facilitated referral for treatment as usual
- Keywords
- Perinatal Depression, Interpersonal Psychotherapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief interpersonal psychotherapyBehavioural
IPT-B sessions include evaluation of participants' level of depression, identification of any difficulties or problems that participants may be experiencing, and review of how to manage these problems using skills learned during treatment.
Facilitated referral for treatment as usualBehavioural
F-TAU includes providing verbal and written information regarding depressive symptoms and a referral for treatment at a behavioral health clinic.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Behavioral: Brief interpersonal psychotherapy |
| B | Active comparator | Not described Receives: Behavioral: Facilitated referral for treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Measured: Measured throughout treatment and at Months 2 and 6 postpartum
Treatment attendance
Measured: Measured at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startMar 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Nancy K. Grote, PhD, Principal investigator, University of Pittsburgh, School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292903
- Sponsor's protocol ID
- MH30915
- Other IDs
- 5R01MH084897-03, DSIR 83-ATSO
- Status last verified
- Sep 2012
- First submitted
- 15 Feb 2006
- Last updated
- 10 Sep 2012
- Results posted
- No
Publications
Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.
PubMed 37146219
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Relevant Brief Interpersonal Psychotherapy (IPT-B) for Perinatal Depression
- ClinicalTrials.gov ID
- NCT00292903
- Acronym / sponsor ID
- MH30915
- Conditions
- Depression
- Keywords
- Perinatal Depression, Interpersonal Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 16 Feb 2006 (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.
This study will compare the effectiveness of brief interpersonal psychotherapy versus standard treatment for pregnant women with depression.
Detailed description
Depression is a serious condition affecting millions of people each year. In fact, it is estimated that approximately one in every four women will be treated for a mood disorder, such as depression, at some point in her life. As effective treatment options continue to develop, many women diagnosed with depression are able to resume normal lives and may choose to become pregnant. Also, some women become depressed when pregnant. Interpersonal psychotherapy involves treating psychological difficulties by analyzing problems, talking about possible solutions, and learning more helpful ways of thinking and acting. Brief interpersonal psychotherapy (IPT-B) is a well-tested psychotherapy for depression that has been shortened and modified. The purpose of this study is to evaluate the effectiveness of IPT-B to reduce depressive symptoms in women during pregnancy and to prevent the continuation or recurrence of their depression postpartum.
Participants in this open-label study will be randomly assigned to receive either IPT-B or a facilitated referral for treatment as usual (F-TAU) at an outpatient clinic or community mental health center. Participants assigned to IPT-B will be scheduled to attend eight treatment sessions along with their prenatal clinic visits within a 16-week period. Each treatment session will begin with a brief 1-minute evaluation to assess participants' level of depression and will end with a brief evaluation of the session. Participants will attend follow-up sessions every 2 weeks until 3 months postpartum and then monthly until 6 months postpartum. These sessions will include evaluation of participants' level of depression, identification of any difficulties or problems that participants may be experiencing, and review of how to manage these problems using skills learned during treatment. Participants assigned to receive F-TAU will be provided with verbal and written information regarding their depressive symptoms. They will also receive a referral for treatment at a behavioral health clinic. Participants receiving F-TAU will be assessed via telephone at Weeks 6 and 12. All participants will be assessed via telephone at Months 2 and 6 postpartum to measure their level of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Brief interpersonal psychotherapy |
| B | Active comparator | Behavioral: Facilitated referral for treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between 8 and 32 weeks of gestation at time of study entry
- A score above 12 on the Edinburgh Postnatal Depression Scale
- Speaks English
- Resides in the Pittsburgh, PA, area
- Access to a household telephone
Key exclusion criteria (8 listed)
- Currently receiving treatment for depression (i.e., medication or psychotherapy)
- History of a prior manic episode
- Alcohol or drug abuse or dependence within 6 months of study entry
- Psychotic disorder or organic mental disorder
- Suicidal, homicidal, or requires hospitalization
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 |
|---|---|---|
| Brief interpersonal psychotherapyIPT-B sessions include evaluation of participants' level of depression, identification of any difficulties or problems that participants may be experiencing, and review of how to manage these problems using skills learned during treatment. | Behavioural | A |
| Facilitated referral for treatment as usualF-TAU includes providing verbal and written information regarding depressive symptoms and a referral for treatment at a behavioral health clinic. | Behavioural | B |
Primary outcome
Depressive symptoms
Time frame: Measured throughout treatment and at Months 2 and 6 postpartum
Treatment attendance
Time frame: Measured at Week 12
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 10 Sep 2012.
- Derived from this study: PubMed 37146219Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.
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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.
Nancy K. Grote, PhD principal investigator
University of Pittsburgh, School of Social Work
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief interpersonal psychotherapy and Facilitated referral for treatment as usual in people with Depression, run by University of Pittsburgh 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 5 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 10 Sep 2012. 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?
Depressive symptoms (time frame: Measured throughout treatment and at Months 2 and 6 postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00292903, which also lists 1 linked publication.
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 10 Sep 2012.