Clinical trial NCT01482832: Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers
Official title: Preventing Postpartum Depression in Adolescent Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Keywords: Randomized trial
Postpartum depression
Adolescent pregnancy
Interpersonal psychotherapy
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Pacific Institute for Research and Evaluation
name: Brown University
First posted: 2011-12-01
Enrollment: 250
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Specific Aim of this study is to conduct a randomized controlled trial to evaluate whether Project REACH (an interpersonal psychotherapy-based intervention) compared with a didactic attention-control program reduces the risk of PPD in adolescent mothers.

Primary Hypothesis:

1. The intervention (Project REACH) will be significantly more efficacious than the control program in reducing the risk of PPD up to six months postpartum in adolescent mothers.

   Secondary Hypotheses:
2. The decreased rate of major depression in the Project REACH group compared to the control program group will be sustained through one year postpartum.
3. Adolescent mothers in Project REACH compared to the control program group will have higher levels of maternal-child bonding.

Detailed description: Each year, more than 400,000 births in the United States are to mothers less than 20 years old. Alarmingly, approximately 25-36% of teen mothers experience postpartum depression (PPD), a condition associated with significant social and health morbidity. PPD places teen mothers and their children at great risk during an already challenging time in their lives. Preventing PPD in this vulnerable population is essential to improving overall health.

Project REACH is a randomized controlled trial, to evaluate whether our novel preventive intervention compared to a didactic attention control reduces the risk of PPD in adolescent mothers. The intervention, REACH (Relax, Encourage, Appreciate, Communicate, Help), is based on Interpersonal Psychotherapy (IPT) and targets those factors that may play a significant role in the development of PPD in adolescent mothers (i.e., poor social support, role transitions and life stressors). The control condition includes didactic prenatal education sessions.

Project REACH builds on the foundation of our NIMH-funded treatment development project and pilot study (R34 MH077588). The pilot study demonstrated feasibility, acceptability and initial efficacy in a small sample. The current R01 proposal aims to evaluate the efficacy of the Project REACH intervention in reducing the risk of PPD.

Eligibility criteria: Inclusion Criteria:

* Less than 24 weeks pregnant
* Not currently being treated for depression
* Speaks and reads English fluently

Exclusion Criteria:

* Currently receiving mental health services from a health care provider
* Meets DSM-IV criteria for an affective disorder, substance use disorder, or psychosis

Primary outcomes:
measure: Diagnosis of depression
timeFrame: within 6 months postpartum
Secondary outcomes:
measure: Degree of depressive symptoms
timeFrame: pre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
Study officials:
affiliation: Women & Infants Hospital
name: Maureen G Phipps, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phipps MG, Ware CF, Stout RL, Raker CA, Zlotnick C. Reducing the Risk for Postpartum Depression in Adolescent Mothers: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):613-621. doi: 10.1097/AOG.0000000000004003.