Feasibility Study: Self-guided Internet-based Cognitive Behavioral Therapy as a Stepped-care Treatment for Mothers With Postpartum Depression.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- The feasibility of the trial procedure will be assessed as a composite outcome consisting of:
研究概览
简要总结
The purpose of this study is to conduct a feasibility study to test the study procedure and a newly developed self-guided internet-based cognitive behavioral therapy program for mothers with postpartum depression.
详细描述
The aim of the feasibility study is twofold: 1) to test the feasibility of the study, and 2) to test the acceptability of the internet-based cognitive behavioral therapy program and to minimize dropout.
The study will be conducted as a mixed-method process evaluation. Twenty mothers will be included in the study. After being informed about the study and its potential, all patients who give written informed consent will be randomized in a 1:1 ratio into either the control group, receiving treatment as usual, or the intervention group, receiving treatment as usual plus the iCBT program iCARE. The intervention period will last for two months.
After the intervention period, investigators will use a survey distributed from REDCap to measure its feasibility, participants' satisfaction with it, and acceptability.
After the two-month intervention period, semi-structured interviews will be conducted with participants from both the intervention and control groups to gather qualitative insights. This feasibility study will also provide a preliminary evaluation of the intervention's impact. The findings from this pilot study will inform the design of the subsequent randomized controlled trial (RCT) and guide any necessary modifications to the treatment program and associated procedures.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Edinburgh Postnatal Depression Scale (EPDS) score 11-18
- •Access to the internet
排除标准
- •Thoughts of self-harm≥2 on EPDS item 10
- •Do not understand Danish language,
- •Substance abuse or dependence
- •Alcohol abuse, defined as a weekly consumption of alcohol exceeding ten units,
- •Physical condition requiring frequent hospitalization like dialysis, chemotherapy, or blood transfusion,
- •A diagnosis of schizophrenia or other psychotic disorders.
研究组 & 干预措施
Internet-based cognitive behavioural therapy program
Participants will have access to an internet-based cognitive behavioral therapy program called iCARE for eight weeks.
干预措施: iCARE (Device)
Treatment as usual
Participants in the control group will receive treatment as usual in their municipality.
结局指标
主要结局
The feasibility of the trial procedure will be assessed as a composite outcome consisting of:
时间窗: Baseline, two-month follow-up, and the six-month follow-up
* Data collection feasibility: measured as assessment completion * Recruitment: measured as the total number of eligible participants, the number who completed the screening questionnaire, and the number of participants completing enrollment per month * Experiences with the trial procedures: Post-intervention, all enrolled participants will participate in a semi-structured interview to evaluate their experiences with the trial procedures. A member of the research team will conduct the interviews.
次要结局
- The acceptability of the intervention will be assessed as a composite outcome consisting of:(Two-month follow-up)
研究者
Trine Munk-Olsen
Professor
University of Southern Denmark