Feasibility and Preliminary Effectiveness of a Bidirectional Peer - Mentor Text Messaging Intervention to Promote Perinatal Mental Health: A Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Change from baseline in depressive symptoms over time as measured by the PHQ-9
研究概览
简要总结
This study tested whether a peer mentor text message program (called the Nurture program) could help support mental health during pregnancy and after birth. In the study, 127 pregnant people in Washington state were randomly placed to in one of two groups: Nurture group - could text with a trained peer mentor and Control group got automated informational text messages. Researchers looked at how much participants used the program and whether it affected symptoms of depression, anxiety and stress related to parenting. Most people in the Nurture group actively used the program. Nearly all responded to their mentor and there was an average of 32 back and forth text conversations. Mentors usually started more conversations than participants did. People using Nurture had lower anxiety six weeks after giving birth compared to the control group. However there were no statistically significant differences between the two groups for depression or parenting stress. The findings suggest that having two way text conversations with peer mentors is well received and may help reduce anxiety soon after birth. More research with larger groups is needed to understand the full benefits and how to make the program widely available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and other birthing individuals receiving prenatal care within Washington.
排除标准
- •Severe mental illness such as bipolar disorder and schizophrenia and severe substance use disorder based on self report.
- •Severe depression symptomology operationalized as PHQ-9 score 20 or higher.
- •Severe suicidality (a response of "Nearly every day" to question 9, "Over the last 2 weeks, how often have you been bothered by any of the following problems?: Thoughts that you would be better off dead or of hurting yourself in some way." on the PHQ-9 questionnaire.
研究组 & 干预措施
Intervention
If assigned to Nurture (intervention arm), the participant was matched with a mentor from Nurture based on participants responses in their intake form which asked if there was anything in particular that they wanted support with and if there were characteristics that were important to them to share with their mentor. The mentor sent weekly messages based on a library of prompts. Prompts provided resources on child development, connections to local support agencies, and suggestions for parent-child bonding and parental wellness activities.
干预措施: Peer mentor texting (Behavioral)
Control
Participants receive automated interventional texts
干预措施: Control (Behavioral)
结局指标
主要结局
Change from baseline in depressive symptoms over time as measured by the PHQ-9
时间窗: Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.
Depressive symptoms in pregnancy and postpartum measured using the Patient Health Questionnaire -9 (PHQ-9). Score range 0 to 27, with higher scores meaning worse depression.
Change from baseline in anxiety symptoms over time, as measured by GAD-7.
时间窗: Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.
Anxiety during pregnancy and postpartum, measured using the Generalized Anxiety disorder Scale (GAD-7). Score range from 0 to 27 with higher scores meaning worse anxiety
Change from baseline to 9 months in Parenting Stress as measured by the Parenting Stress Scale
时间窗: 6 weeks and 9 months postpartum.
Parenting Stress measured using the Parenting Stress Scale. An 18 - item self report scale - items represent positive (e.g. emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. Overall possible scores on the scale range from 18 - 90. The higher the score , the higher the measured level of Parental stress
Feasibility of enrolment as measured by number of participants enrolled
时间窗: Baseline
Ability to enroll into the study
Intervention engagement as measured by number of messages exchanged
时间窗: Baseline, 9 months postpartum
Engagement measured by number of messages exchanged
次要结局
- Change from baseline in General Wellbeing over time as measured by the General Wellbeing Schedule(Baseline, 6 weeks, 3 months, 6 months and 9 months postpartum.)
- Change in Maternal self efficacy from baseline over time as measures by the Self Efficacy in a Nurturing Role questionnaire.(Baseline, 6 weeks and 9 months postpartum.)
- Change in wellbeing from baseline to 9 months as measured by the Flourishing scale(Baseline and 9 months postpartum.)
- Social support(Baseline, 3 months and 9 months postpartum.)
研究者
Amritha Subray Bhat
Associate Professor
University of Washington