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

Feasibility Study: Self-guided Internet-based Cognitive Behavioral Therapy as a Stepped-care Treatment for Mothers With Postpartum Depression.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postpartum Depression; Internet-based Intervention
• Intervention / Treatment: Device: iCARE

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anja F Elliott, MD; Phone Number: +45 24 85 50 31; Email: anja.friis.elliott@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based cognitive behavioural therapy program; Participants will have access to an internet-based cognitive behavioral therapy program called iCARE for eight weeks.	Device: 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
No Intervention: Treatment as usual; Participants in the control group will receive treatment as usual in their municipality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The acceptability of the intervention will be assessed as a composite outcome consisting of:	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.	Two-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of depressive symptoms	Edinburg Postnatal Depression Scale (EPDS). It is a ten-item questionnaire, with scores ranging from 0 to 30. Higher scores indicate a worse outcome.	Baseline, two-month follow-up, and the six-month follow-up
Adverse effects of the intervention	Negative Effects Questionnaire (NEQ). The questionnaire includes general information about the possibility of experiencing negative effects and is comprised of three separate parts: 1) "Did you experience this?" (yes/no) 2) "If yes-here is how negatively it affected me" (not at all, slightly, moderately, very, and extremely), and 3) "Probably caused by" (the treatment I received/other circumstances). The questionnaire contains 32 items, and how negatively the negative effect was is measured on a four-point Likert scale, ranging from 0-4 ("0" being minimum and "4" being maximum). Higher scores indicate a worse outcome.	Two-month follow-up
The frequency of occurrence of automatic negative thoughts	The Automatic Thoughts Questionnaire (ATQ). The questionnaire consists of 30 items with a 5-point Likert scale. Scores range from 30 to 150, with higher scores indicating a worse outcome.	Two-month follow-up
Individuals' typical levels of difficulties in emotion regulation	The Difficulties in Emotion Regulation Scale - 16-item version (DERS-16). The questionnaire consists of 16 items that assess emotion regulation difficulties. The total score ranges from 16 to 80, with higher scores indicating more difficulties with emotion regulation.	Two-month follow-up
Level of stress associated with raising children	Danish Parental Stress Scale (DPSS). This is an 18-item measure of parental stress rated on a five-point scale (Strongly disagree, Disagree, Undecided, Agree, Strongly agree). The total score range is from 18 to 90, and a low score indicates less stress.	Two-month follow-up
The social-emotional development of children	The Ages and Stages Questionnaire Social-Emotional Six Month (ASQ-SE-2): The questionnaire comprises 23 scored items with higher scores indicating a worse outcome.	Two-month follow-up
Disability/functioning	World Health Organization disability assessment schedule 2.0 12 items: The questionnaire consists of 12 items, measured by a 5-point scale, with scores ranging from 12 to 60. Higher scores indicate a worse outcome.	Baseline, two-month follow-up, and the six-month follow-up
levels of anxiety	Generalized Anxiety Disorder Assessment (GAD-7): This questionnaire screens levels of anxiety and consists of 7 items scored on a 0-3 scale from 0 to 21. Higher scores indicate a worse outcome.	Baseline, two-month follow-up, and the six-month follow-up

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: University of Copenhagen; University of Aarhus; Region of Southern Denmark
• Investigators: Principal Investigator: Trine Munk-Olsen, prof., University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Web-based intervention; Cognitive behavioral therapy; Postpartum depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 12.250 (Other Identifier: University of Southern Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No