Feasibility Study: Self-guided iCBT for Mothers With Postpartum Depression.

Официальное название

Feasibility Study: Self-guided Internet-based Cognitive Behavioral Therapy as a Stepped-care Treatment for Mothers With Postpartum Depression.

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство iCARE
  iCARE is an internet-based cognitive behavioral therapy program designed for women experiencing symptoms of postpartum depression, including anxiety, irritability, and sadness. The program offers digital therapy through an online platform tailored to mothers with mild to moderate postpartum depression. The program consists of 7 modules, each with its own theme, incorporating cognitive behavioral therapy, a well-established therapeutic approach for depression. The content includes text, images, a

Первичные конечные точки

• The feasibility of the trial procedure will be assessed as a composite outcome consisting of: [Срок оценки: Baseline, two-month follow-up, and the six-month follow-up]

Вторичные конечные точки (1)

• The acceptability of the intervention will be assessed as a composite outcome consisting of: [Срок оценки: Two-month follow-up]

Критерии участия

Критерии включения

• Edinburgh Postnatal Depression Scale (EPDS) score 11-18
• ≥age 18
• Access to the internet

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06569875 · 12.250

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗