DepressionNCT00183547
Depression Prevention Program for American Indian Adolescents During and After Pregnancy
A study testing "Living in Harmony" depression prevention program and Depression-prevention education and support in people with Depression and Pregnancy, run by Johns Hopkins University at 2 sites in United States.
Trial summary
This study will determine the effectiveness of the "Living in Harmony" depression prevention program in preventing depressive symptoms among pregnant American Indian adolescents during pregnancy and after giving birth. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Pregnancy
- What is being tested?
- "Living in Harmony" depression prevention program and Depression-prevention education and support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to Sep 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 15 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- At 28th week or earlier of pregnancy
- Center for Epidemiologic Studies-Depression Scale (CES-D) score of 16 or higher
- Identified (by others and by self) as an American Indian
- Currently live on an American Indian reservation
- Parent or guardian willing to give consent, if applicable
- Willing and able to comply with all study requirements
Who cannot join
- Diagnosis of major depressive disorder
- Current psychiatric disorder or condition requiring intervention or treatment
- Current participation in another mental or behavioral health study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Center for American Indian Health
Baltimore, Maryland, 21205
Johns Hopkins Center for American Indian Health
Whiteriver, Arizona, 85941
About this study
Official title: Depression Prevention in Pregnant American Indian Teens Using CBT
This study will determine the effectiveness of the "Living in Harmony" depression prevention program in preventing depressive symptoms among pregnant American Indian adolescents during pregnancy and after giving birth.
Read the detailed description
Pregnancy among reservation-based American Indian adolescents has become increasingly common. Numerous psychosocial and environmental factors have put this population at high risk for pregnancy-related depression. Depression during pregnancy and after giving birth is associated with reduced quality of life for both young mothers and their children. Many reservations lack mental health services; therefore, an inexpensive intervention is needed to prevent depressive symptoms among pregnant adolescents who live on reservations.
The duration of this study will vary for each participant, depending on the time of study entry. Participants will be randomly assigned to receive weekly sessions of either the "Living in Harmony" program, consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support; or general depression-prevention education and support. Participants' depressive symptoms will be assessed at study entry, at 4, 12, and 24 weeks after giving birth, and study completion. Interviews and self-report scales will be used to assess participants.
- Conditions
- Depression, Pregnancy
- Being tested
- "Living in Harmony" depression prevention program, Depression-prevention education and support
- Keywords
- Postpartum Depression, Postpartum Period, Indians, North American, Adolescent, Female, CBT
- Medical subject headings
- Depression, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Living in Harmony" depression prevention programBehavioural
Weekly therapy sessions consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support
Depression-prevention education and supportBehavioural
Weekly therapy sessions offering general depression-prevention education and support
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | "Living in Harmony" depression prevention program Receives: Behavioral: "Living in Harmony" depression prevention program |
| 2 | Active comparator | Depression-prevention education and support Receives: Behavioral: Depression-prevention education and support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum depression
Measured: up to 24 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionMar 2007
- Study completionSep 2007
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 Johns Hopkins UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Golda Ginsburg, PhD, Principal investigator, Johns Hopkins Center for American Indian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183547
- Sponsor's protocol ID
- R34MH071300
- Other IDs
- R34MH071300, DSIR 84-CTP
- Status last verified
- Dec 2008
- First submitted
- 13 Sep 2005
- Last updated
- 29 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression Prevention in Pregnant American Indian Teens Using CBT
- ClinicalTrials.gov ID
- NCT00183547
- Acronym / sponsor ID
- R34MH071300
- Conditions
- Depression, Pregnancy
- Keywords
- Postpartum Depression, Postpartum Period, Indians, North American, Adolescent, Female, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Sep 2007
- First posted
- 16 Sep 2005 (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 determine the effectiveness of the "Living in Harmony" depression prevention program in preventing depressive symptoms among pregnant American Indian adolescents during pregnancy and after giving birth.
Detailed description
Pregnancy among reservation-based American Indian adolescents has become increasingly common. Numerous psychosocial and environmental factors have put this population at high risk for pregnancy-related depression. Depression during pregnancy and after giving birth is associated with reduced quality of life for both young mothers and their children. Many reservations lack mental health services; therefore, an inexpensive intervention is needed to prevent depressive symptoms among pregnant adolescents who live on reservations.
The duration of this study will vary for each participant, depending on the time of study entry. Participants will be randomly assigned to receive weekly sessions of either the "Living in Harmony" program, consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support; or general depression-prevention education and support. Participants' depressive symptoms will be assessed at study entry, at 4, 12, and 24 weeks after giving birth, and study completion. Interviews and self-report scales will be used to assess participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: "Living in Harmony" depression prevention program"Living in Harmony" depression prevention program |
| 2 | Active comparator | Behavioral: Depression-prevention education and supportDepression-prevention education and support |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- At 28th week or earlier of pregnancy
- Center for Epidemiologic Studies-Depression Scale (CES-D) score of 16 or higher
- Identified (by others and by self) as an American Indian
- Currently live on an American Indian reservation
- Parent or guardian willing to give consent, if applicable
Key exclusion criteria (3 listed)
- Diagnosis of major depressive disorder
- Current psychiatric disorder or condition requiring intervention or treatment
- Current participation in another mental or behavioral health study
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 |
|---|---|---|
| "Living in Harmony" depression prevention programWeekly therapy sessions consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support | Behavioural | 1 |
| Depression-prevention education and supportWeekly therapy sessions offering general depression-prevention education and support | Behavioural | 2 |
Primary outcome
Postpartum depression
Time frame: up to 24 weeks postpartum
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 29 May 2013.
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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.
Golda Ginsburg, PhD principal investigator
Johns Hopkins Center for American Indian Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Living in Harmony" depression prevention program and Depression-prevention education and support in people with Depression and Pregnancy, run by Johns Hopkins University at 2 sites 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 3 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 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Postpartum depression (time frame: up to 24 weeks postpartum). 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 29 May 2013.