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Depression, PostpartumPhase 1NCT00602732

Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse

A Phase 1 study testing The Reach Out for a Safe Environment (ROSE) program and Enhanced care as usual (ECU) in people with Depression, Postpartum and Depression, run by Butler Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the effectiveness of an interpersonally oriented treatment program called Reach Out for a Safe Environment in preventing depression and post-traumatic stress disorder in low-income pregnant women who have experienced recent partner abuse. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Depression, Postpartum, Depression
What is being tested?
The Reach Out for a Safe Environment (ROSE) program and Enhanced care as usual (ECU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Sep 2005to Dec 2013
Phase
Phase 1
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 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Able to speak and read English sufficiently to complete the study procedures
  • Willing and able to receive public assistance
  • Identified as having experienced physical assault based on responses to CTS2 within 1 year prior to study entry
  • 35 weeks or less gestation

Who cannot join

  • Meets current criteria for major depressive disorder or post-traumatic stress disorder

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Memorial Hospital

    Providence, Rhode Island, 02905

Other trials in United States

About this study

Official title: Intervention for Low-income Pregnant Women With Partner Abuse

This study will evaluate the effectiveness of an interpersonally oriented treatment program called Reach Out for a Safe Environment in preventing depression and post-traumatic stress disorder in low-income pregnant women who have experienced recent partner abuse.

Read the detailed description

Each year, approximately 324,000 pregnant women experience partner abuse (PA). With the emotional highs and lows that accompany new motherhood, pregnancy is often a challenging process for many women. Experiencing PA, while already going through a vulnerable time during pregnancy, may have harmful effects on the well-being of the woman and her infant. Women affected by PA are at an increased risk for certain physical and psychological problems, including depression and post-traumatic stress disorder (PTSD). Furthermore, the emotional distress from PA may impair a woman's ability to seek out the necessary support to ensure the safety of herself and her children. There have been few research efforts to develop an effective treatment to reduce the psychological impact of PA on pregnant women and even fewer efforts that target low-income women, who make up a large portion of affected women. The Reach Out for a Safe Environment (ROSE) program is an interpersonally oriented treatment developed to address factors that may contribute to postpartum mental health difficulties associated with PA. This study will evaluate the effectiveness of the ROSE program in preventing depression and PTSD in low-income pregnant women who have experienced recent PA.

Participation in this single-blind study will last approximately 29 weeks. All potential participants will answer an initial questionnaire concerning their history of physical, sexual, or emotional abuse in the past year. Selected participants will then undergo an interview about symptoms of depression, reactions to trauma, emotional difficulties, and alcohol and drug use. Participants invited to continue in the study will then be randomly assigned to the ROSE program or enhanced care as usual (ECU). Participants assigned to the ROSE program will attend four weekly 90-minute group sessions prior to delivery and one individual 50-minute booster session within 4 weeks of delivery. During these sessions, participants will learn ways to manage stress and negative feelings and how to access helpful resources. Participants will also complete two questionnaires about emotional difficulties per week for the duration of the program. Participants assigned to ECU will receive the usual medical care provided for pregnant women and will receive educational material on depression.

All participants will complete questionnaires and interviews about their emotional difficulties, relationships with others, and use of services for these difficulties prior to treatment assignment, 4 weeks after treatment assignment, 4 weeks after delivery, and 3 months after delivery. Participants in the ROSE program will additionally complete a questionnaire about their perceptions of the program after the fourth treatment session and after the booster session.

Being tested
The Reach Out for a Safe Environment (ROSE) program, Enhanced care as usual (ECU)
Keywords
Partner Abuse, Preventive Intervention, Postpartum Depression, Postpartum PTSD
Medical subject headings
Depression, Postpartum, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Reach Out for a Safe Environment (ROSE) programBehavioural

    Also called Reach Out Stay Strong: Essentials for New Mothers

    Participants in the ROSE program will receive a course on managing stress and negative feelings and will learn how to access resources for help. The ROSE program involves four 90-minute group sessions over a 4-week period prior to delivery. Participants will also attend one 50-minute booster session within 4 weeks prior to delivery of their babies.

  • Enhanced care as usual (ECU)Behavioural

    Participants in ECU will receive the usual medical care provided for pregnant women at their prenatal clinic. Participants will also receive educational material and a list of treatment resources for depression.

Study groups in NCT00602732
Study groupRoleWhat they receive
1ExperimentalParticipants assigned to the ROSE program
Receives: Behavioral: The Reach Out for a Safe Environment (ROSE) program
2Active comparatorParticipants assigned to enhanced care as usual
Receives: Behavioral: Enhanced care as usual (ECU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Longitudinal Interval Follow-up Examination (LIFE)

    Measured: Measured at Year 1

Secondary outcomes (5)
  1. Revised Conflict Tactic Scale (CTS2)

    Measured: Measured at Year 1

  2. Edinburgh Postnatal Depression Scale

    Measured: Measured at Year 1

  3. The Davidson Trauma Scale

    Measured: Measured at Year 1

  4. The Arizona Social Support Interview Schedule

    Measured: Measured at Year 1

  5. Parenting Stress Index

    Measured: Measured at Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2008 (estimated)
  2. Study startSep 2005
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00602732
Sponsor's protocol ID
R34MH075013
Other IDs
R34MH075013, DSIR 83-ATP
Status last verified
Mar 2014
First submitted
22 Jan 2008
Last updated
28 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing The Reach Out for a Safe Environment (ROSE) program and Enhanced care as usual (ECU) in people with Depression, Postpartum and Depression, run by Butler 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 4 inclusion and 1 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 28 Mar 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Longitudinal Interval Follow-up Examination (LIFE) (time frame: Measured at Year 1). 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 28 Mar 2014.

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