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

NCT06569875 | Not Yet Recruiting

• 1 other identifier: 12.250
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postpartum Depression; Internet-based Intervention

Keywords

Cognitive behavioral therapy; Postpartum depression; Web-based intervention

Outcome Measures

Primary Outcomes (1)

• The feasibility of the trial procedure will be assessed as a composite outcome consisting of:

  * 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.

  Baseline, two-month follow-up, and the six-month follow-up

Secondary Outcomes (1)

• The acceptability of the intervention will be assessed as a composite outcome consisting of:

  Two-month follow-up

Other Outcomes (8)

• Severity of depressive symptoms

  Baseline, two-month follow-up, and the six-month follow-up

• Adverse effects of the intervention

  Two-month follow-up

• The frequency of occurrence of automatic negative thoughts

  Two-month follow-up

Study Arms (2)

Internet-based cognitive behavioural therapy program

EXPERIMENTAL

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

Device: iCARE

Treatment as usual

NO INTERVENTION

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

Interventions

iCARE 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

Internet-based cognitive behavioural therapy program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern Denmark: lead
• Region of Southern Denmark: collaborator
• University of Copenhagen: collaborator
• University of Aarhus: collaborator

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Trine Munk-Olsen, prof.

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anja F Elliott, MD

CONTACT

+45 24 85 50 31; anja.friis.elliott@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: September 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: October 30, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share