Clinical trial NCT06569875: Feasibility Study: Self-guided iCBT for Mothers With Postpartum Depression.
Official title: Feasibility Study: Self-guided Internet-based Cognitive Behavioral Therapy as a Stepped-care Treatment for Mothers With Postpartum Depression.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postpartum Depression
Internet-based Intervention
Keywords: Cognitive behavioral therapy
Postpartum depression
Web-based intervention
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: University of Copenhagen
name: University of Aarhus
First posted: 2024-08-26
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The feasibility of the trial procedure will be assessed as a composite outcome consisting of:
timeFrame: Baseline, two-month follow-up, and the six-month follow-up
Secondary outcomes:
measure: The acceptability of the intervention will be assessed as a composite outcome consisting of:
timeFrame: Two-month follow-up
Other outcomes:
measure: Severity of depressive symptoms
timeFrame: Baseline, two-month follow-up, and the six-month follow-up
measure: Adverse effects of the intervention
timeFrame: Two-month follow-up
measure: The frequency of occurrence of automatic negative thoughts
timeFrame: Two-month follow-up
measure: Individuals' typical levels of difficulties in emotion regulation
timeFrame: Two-month follow-up
measure: Level of stress associated with raising children
timeFrame: Two-month follow-up
measure: The social-emotional development of children
timeFrame: Two-month follow-up
measure: Disability/functioning
timeFrame: Baseline, two-month follow-up, and the six-month follow-up
measure: levels of anxiety
timeFrame: Baseline, two-month follow-up, and the six-month follow-up
Locations:
Study officials:
affiliation: University of Southern Denmark
name: Trine Munk-Olsen, prof.
role: PRINCIPAL_INVESTIGATOR
References: