Postpartum DepressionNCT06569875
Feasibility Study: Self-guided iCBT for Mothers With Postpartum Depression.
A study testing iCARE in people with Postpartum Depression and Internet-based Intervention, run by University of Southern Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression, Internet-based Intervention
- What is being tested?
- iCARE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Edinburgh Postnatal Depression Scale (EPDS) score 11-18
- ≥age 18
- Access to the internet
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- iCARE
- Keywords
- Cognitive behavioral therapy, Postpartum depression, Web-based intervention
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCAREDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Internet-based cognitive behavioural therapy program | Experimental | Participants will have access to an internet-based cognitive behavioral therapy program called iCARE for eight weeks. Receives: Device: iCARE |
| Treatment as usual | No intervention | Participants in the control group will receive treatment as usual in their municipality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
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.
Measured: Two-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, University of Copenhagen, University of Aarhus
- Responsible party
- Principal investigator, Trine Munk-Olsen, University of Southern Denmark
- Investigators
- Trine Munk-Olsen, prof., Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569875
- Sponsor's protocol ID
- 12.250
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: Self-guided Internet-based Cognitive Behavioral Therapy as a Stepped-care Treatment for Mothers With Postpartum Depression.
- ClinicalTrials.gov ID
- NCT06569875
- Acronym / sponsor ID
- 12.250
- Conditions
- Postpartum Depression, Internet-based Intervention
- Keywords
- Cognitive behavioral therapy, Postpartum depression, Web-based intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, University of Copenhagen, University of Aarhus
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based cognitive behavioural therapy program | Experimental | Device: iCAREParticipants will have access to an internet-based cognitive behavioral therapy program called iCARE for eight weeks. |
| Treatment as usual | No intervention | –Participants in the control group will receive treatment as usual in their municipality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Edinburgh Postnatal Depression Scale (EPDS) score 11-18
- ≥age 18
- Access to the internet
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCAREiCARE 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 | Device | Internet-based cognitive behavioural therapy program |
Primary outcome
The feasibility of the trial procedure will be assessed as a composite outcome consisting of:
Time frame: 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.
1 secondary outcome
The acceptability of the intervention will be assessed as a composite outcome consisting of:
Time frame: Two-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trine Munk-Olsen, prof. principal investigator
University of Southern Denmark
Questions about this trial
What is this clinical trial studying?
A study testing iCARE in people with Postpartum Depression and Internet-based Intervention, run by University of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anja F Elliott, MD (+45 24 85 50 31, anja.friis.elliott@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of the trial procedure will be assessed as a composite outcome consisting of: (time frame: Baseline, two-month follow-up, and the six-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.