Depression, PostpartumNCT00051246
Group Therapy for Postpartum Depression
A study testing Mother-Infant Group Psychotherapy and Interpersonal Psychotherapy in people with Depression, Postpartum, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will compare standard individual treatment to group therapy for the treatment of postpartum depression. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- Mother-Infant Group Psychotherapy and Interpersonal Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Jul 2008
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depression with an infant under 7 months of age
Who cannot join
- Bipolar disorder
- Schizophrenia
- Organic brain syndrome
- Antisocial personality disorder
- Current psychosis or mania
- Lifetime history of mental retardation
Show all 9Show fewer
- Current alcohol or substance abuse
- Cognitive disability
- Infants born more than 6 weeks premature or with major medical conditions or developmental disabilities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Dept. of Psychiatry
Madison, Wisconsin, 53719
About this study
Official title: Relational Group Intervention for Postpartum Depression
This study will compare standard individual treatment to group therapy for the treatment of postpartum depression.
Read the detailed description
Ten to twenty percent of new mothers experience major depression in the postpartum period or postpartum depression (PPD). This condition poses a risk for disturbances in the mother-infant relationship as well as for developmental delays and subsequent psychopathology in their children. Thus, and investigation of the efficacy of a relational approach that focuses on improving the mother's sense of competence in the parenting role, and reducing depressive symptoms and social isolation through group therapy is warranted.
Patients are randomly assigned to either relational group treatment or to standard individual treatment. Assessments of maternal and infant functioning, mother-infant and father-infant relations, parenting stress, and marital conflict and conducted pre- and post-treatment, at 12 months post-treatment, and when infants are 12 and 24 months of age.
- Conditions
- Depression, Postpartum
- Being tested
- Mother-Infant Group Psychotherapy, Interpersonal Psychotherapy
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother-Infant Group PsychotherapyBehavioural
Mother-infant group psychotherapy consists of weekly 2.5-hour psychotherapy sessions comprised of mother's group therapy, infant developmental therapy, and mother-infant dyadic psychotherapy. Group treatment will last 15 weeks.
Interpersonal PsychotherapyBehavioural
Individual psychotherapy treatment focuses on role transition, interpersonal relationships, and loss. Individual treatment period will last 15 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 M-ITG | Active comparator | Mother-infant group psychotherapy Receives: Behavioral: Mother-Infant Group Psychotherapy |
| 2 - IPT | Active comparator | Individual interpersonal psychotherapy Receives: Behavioral: Interpersonal Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of depression as measured by the Hamilton Rating Scale for Depression (HRSD)
Measured: Measured at post-treatment and Month 12 follow-up
Secondary outcomes (1)
Improvement in parent-infant interactions as measured by the Early Relational Assessment (ERA)
Measured: Measured at post-treatment, Month 12 follow-up, and 12 and 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2003 (estimated)
- Study startJan 2002
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Roseanne Clark, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051246
- Sponsor's protocol ID
- R01MH062054
- Other IDs
- R01MH062054
- Status last verified
- Jan 2014
- First submitted
- 7 Jan 2003
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relational Group Intervention for Postpartum Depression
- ClinicalTrials.gov ID
- NCT00051246
- Acronym / sponsor ID
- R01MH062054
- Conditions
- Depression, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2002
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 8 Jan 2003 (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 standard individual treatment to group therapy for the treatment of postpartum depression.
Detailed description
Ten to twenty percent of new mothers experience major depression in the postpartum period or postpartum depression (PPD). This condition poses a risk for disturbances in the mother-infant relationship as well as for developmental delays and subsequent psychopathology in their children. Thus, and investigation of the efficacy of a relational approach that focuses on improving the mother's sense of competence in the parenting role, and reducing depressive symptoms and social isolation through group therapy is warranted.
Patients are randomly assigned to either relational group treatment or to standard individual treatment. Assessments of maternal and infant functioning, mother-infant and father-infant relations, parenting stress, and marital conflict and conducted pre- and post-treatment, at 12 months post-treatment, and when infants are 12 and 24 months of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 M-ITG | Active comparator | Behavioral: Mother-Infant Group PsychotherapyMother-infant group psychotherapy |
| 2 - IPT | Active comparator | Behavioral: Interpersonal PsychotherapyIndividual interpersonal psychotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major depression with an infant under 7 months of age
Key exclusion criteria (9 listed)
- Bipolar disorder
- Schizophrenia
- Organic brain syndrome
- Antisocial personality disorder
- Current psychosis or mania
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 |
|---|---|---|
| Mother-Infant Group PsychotherapyMother-infant group psychotherapy consists of weekly 2.5-hour psychotherapy sessions comprised of mother's group therapy, infant developmental therapy, and mother-infant dyadic psychotherapy. Group treatment will last 15 weeks. | Behavioural | 1 M-ITG |
| Interpersonal PsychotherapyIndividual psychotherapy treatment focuses on role transition, interpersonal relationships, and loss. Individual treatment period will last 15 weeks. | Behavioural | 2 - IPT |
Primary outcome
Reduction of depression as measured by the Hamilton Rating Scale for Depression (HRSD)
Time frame: Measured at post-treatment and Month 12 follow-up
1 secondary outcome
Improvement in parent-infant interactions as measured by the Early Relational Assessment (ERA)
Time frame: Measured at post-treatment, Month 12 follow-up, and 12 and 24 months of age
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 24 Jan 2014.
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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.
Roseanne Clark, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother-Infant Group Psychotherapy and Interpersonal Psychotherapy in people with Depression, Postpartum, run by University of Wisconsin, Madison 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 1 inclusion and 9 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 24 Jan 2014. 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?
Reduction of depression as measured by the Hamilton Rating Scale for Depression (HRSD) (time frame: Measured at post-treatment and Month 12 follow-up). 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 24 Jan 2014.