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

NCT ID: NCT06569875

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-10-30

Brief Summary

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.

Detailed 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.

Conditions

Postpartum Depression; Internet-based Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-based cognitive behavioural therapy program

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

Group Type: EXPERIMENTAL

iCARE

Intervention Type: DEVICE

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, audio files, and short films, supplemented with small tasks to provide knowledge and tools to understand and manage one's situation. The treatment course is self-directed, allowing participants to engage with the content at their own pace and at times that are most convenient for them

Treatment as usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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, audio files, and short films, supplemented with small tasks to provide knowledge and tools to understand and manage one's situation. The treatment course is self-directed, allowing participants to engage with the content at their own pace and at times that are most convenient for them

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Region of Southern Denmark

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Trine Munk-Olsen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trine Munk-Olsen, prof.

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Central Contacts

Anja F Elliott, MD

Role: CONTACT

anja.friis.elliott@rsyd.dk

+45 24 85 50 31

Other Identifiers

12.250

Identifier Type: -

Identifier Source: org_study_id