Feasibility Study: Self-guided iCBT for Mothers With Postpartum Depression.
- Conditions
- Postpartum DepressionInternet-based Intervention
- Interventions
- Device: iCARE
- Registration Number
- NCT06569875
- Lead Sponsor
- University of Southern Denmark
- Brief Summary
The purpose of this study is to conduct a pilot study to test study procedure and a newly developed self-guided internet-based cognitive behavioural therapy program for mothers with postpartum depression.
Our hypotheses is :
1. The feasibility study will indicate adherence to the program and its produceres.
2. The treatment will be acceptable to participants, and the internet-based cognitive behavioural therapy program and internet format will be user-friendly, resulting in low dropout rates.
- 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 behavioural therapy program and on minimizing drop out.
The iCBT program, known as iCARE, is designed to address mild to moderate postpartum depression.
The study will be conducted as a mixed-method process evaluation. Twenty mothers will be randomized into either the control group, receiving treatment as usual, or the intervention group, receiving treatment as usual plus the iCBT program iCARE, with ten mothers in each group. The intervention will last for two months.
After the intervention period, we will measure the feasibility, participants' satisfaction with the intervention, and acceptability of the intervention. The effectiveness of the intervention will be assessed by measuring the reduction in depressive symptoms and we will report any adverse effects ofthe intervention. Other measurements will examine the program's impact on various maternal mental health outcomes, such as negative automatic thoughts, emotional regulation, parenting stress, children's socio-emotional development, anxiety, and everyday functioning. These outcomes may serve as potential mediators, helping to elucidate the underlying mechanisms that contribute to the reduction in depressive symptoms.
After two months, semi-structured interviews will be conducted with mothers from the intervention group to assess their subjective perspectives on barriers and facilitators to participating in iCARE. Interviews will also be conducted with mothers in the control group to understand the treatment they received, if any, and to gather their thoughts on the available offers. The development of the interview guide for the semi-structured interviews in both groups is currently in progress. Clarke and Braun's thematic analysis will be applied to the interview data.
The feasibility study will also serve as a preliminary evaluation of the intervention's impact. The results from the pilot study will inform the subsequent RCT and guide any necessary revisions to the treatment program and procedures.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 20
- Edinburgh Postnatal Depression Scale (EPDS) score 11-18
- ≥age 18
- Access to the internet
- Thoughts of self harm ≥2 on EPDS item 10
- Do not understand Danish language,
- Substance abuse or dependence
- Alcohol abuse, defined by a weekly consumption of alcohol exceeding 10 units,
- Physical condition requiring frequent hospitalization like dialysis, chemotherapy, or blood transfusion,
- A diagnosis of schizophrenia, or other psychotic disorders.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Internet-based cognitive behavioural therapy program iCARE Participants will have access to an internet-based cognitive behavioral therapy program called iCARE for eight weeks.
- Primary Outcome Measures
Name Time Method The feasibility of the trial procedure will be assessed as a composite outcome consisting of: Baseline, two-month follow-up, and the six-month follow-up * 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.
- Secondary Outcome Measures
Name Time Method The acceptability of the intervention will be assessed as a composite outcome consisting of: Two-month follow-up The acceptability of the intervention will be assessed as a composite outcome consisting of:
* The Client Satisfaction Questionnaire (CSQ-8) will measure participants' satisfaction with the intervention. The questionnaire consists of eight items measured on a four-point scale, with total scores ranging from 8 to 32, with a higher number indicating greater satisfaction.
* The System Usability Scale (SUS) will measure participants' perceptions of the software's usability. The questionnaire consists of ten items measured on a five-point scale, with total scores ranging from 0 to 100, with a higher number indicating a better outcome.
* Experiences using the intervention: Post-intervention, participants in the intervention group will assess their experiences using the intervention and any issues related to it. A research team member will conduct semi-structured interviews with the participants.