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

University of Southern Denmark (SDU)

Status: Not yet enrolling

Conditions: Internet-based Intervention; Postpartum Depression

Treatments: Device: iCARE

Study type: Interventional

Funder types: Other

Identifiers

NCT06569875

12.250

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Internet-based cognitive behavioural therapy program

Experimental group

Description:

Participants will have access to an internet-based cognitive behavioral therapy program called iCARE for eight weeks.

Treatment:

Device: iCARE

Treatment as usual

No Intervention group

Description:

Participants in the control group will receive treatment as usual in their municipality.