An Early Phase 1 interventional study of Web-based program for postpartum depression in Postpartum Depression (PPD) and Web-based Intervention, sponsored by Babes-Bolyai University. Recruiting at 1 site in Romania. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Babes-Bolyai University · Early Phase 1, Interventional, and Other
This study evaluates a Web-based intervention program to treat women with postpartum depression.
Although psychological interventions are effective in decreasing depressive symptoms during the postpartum period, of the women affected, only 13% seek professional help. Common barriers are lack of time, stigma, child care needs, reduced mobility following childbirth, and lack of access to treatment in some regions. Web-based therapy programs have the potential to be effective in reducing postpartum depression (PPD) and to increase the access to treatment. The limited number of studies testing web-based programs for postpartum depression and the small sample sizes used reveal a field in early development.
The aim of the present trial is to investigate the feasibility, usability and user engagement of an internet-based treatment program for postpartum depression with therapist guidance. The program was developed de novo by the authors, and it is currently the only psychological treatment of its kind available in Romania. It consists of 5 weekly online multimedia modules (+5 optional ones), 3 bi-weekly 45 minutes group meetings and support provided by a psychotherapist.
Women with PPD symptoms will access the intervention program in order to provide feedback regarding its content and structure. Assessments will occur at baseline, post-treatment, and 1-month follow-up and will include questionnaires and a semi-structured interview. Preliminary information will be collected about changes in depression, anxiety, unrealistic standards for the maternal role, and psychological flexibility.
By assessing the level of usability and user engagement, we ensure that the program's design and content allow for the implementation of the intervention in a way that is accessible, user-friendly, and engaging for the target population. Furthermore, by evaluating the feasibility of the approach, we ensure that a future controlled clinical trial can be initiated from an ethical, practical, and logistical standpoint. Consequently, this study serves as an essential preparatory phase, enabling the testing of the program's efficacy in a subsequent study.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 30 is below the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Babes-Bolyai University is the lead sponsor of 51 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Participants will receive the online intervention program for postpartum depression.
Device: Web-based program for postpartum depression
The program includes 10 modules (5 mandatory and 5 optional) and 3 bi-weekly 45 min group meeting with a psychotherapist. The modules cover topics specific to postpartum depression (e.g. perfectionistic beliefs about motherhood, asking for social support) or the context of raising a baby (e.g., making time for self care). Each group consists of 3 and 6 participants. The communication and meetings are facilitated via a WhatsApp group. The meetings are scheduled after the first module, module 2 \& 3 and module 4 \& 5. In the group meeting the therapist answers questions regarding the content of the modules, discusses concrete examples and introduces upcoming content. After the 5 mandatory weekly modules are completed, participants may request can request an optional individual 45-minutes session with her designated therapist. This meeting has the goal of offering extra support for challenges that may have not been covered in the modules or to offer more suggestions for applying techniques.
Program Usability
The System Usability Scale - scores can range from 0 (indicating very low perceived usability) to 100 (indicating excellent perceived usability)
Time frame: post-test (immediately following the third group meeting and the completion of the five mandatory modules)
Program Usability
A semi-structured interview - the responses will be transcribed and analyzed to derive conclusions regarding the program's perceived usability and to identify specific suggestions for further improvements
Time frame: post-test (immediately following the third group meeting and the completion of the five mandatory modules), during a scheduled session dedicated to administering the semi-structured interview
Participant Engagement
A semi-structured interview - the responses will be transcribed and analyzed to derive conclusions regarding the program's perceived engagement and to identify specific suggestions for further improvements
Time frame: post-test (immediately following the third group meeting and the completion of the five mandatory modules), during a scheduled session dedicated to administering the semi-structured interview
Postpartum Depression
The Edinburgh Postnatal Depression Scale - scores range from 0 to 30, with higher scores indicating a higher level of symptom severity
Time frame: baseline, post-test (immediately following the third group meeting and the completion of the five mandatory modules), and one-month follow-up (one month after program completion)
Postpartum Depression
Patient Health Questionnaire (9-item version) - scores range from 0 to 27, with higher scores indicating a more severe level of symptoms
Time frame: baseline, post-test (immediately following the third group meeting and the completion of the five mandatory modules), and one-month follow-up (one month after program completion)
Anxiety
Generalized Anxiety Disorder-7 - scores range from 0 to 21, with higher scores indicating a higher level of symptom severity
Time frame: baseline, post-test (immediately following the third group meeting and the completion of the five mandatory modules), and one-month follow-up (one month after program completion)
Rigid attitudes toward motherhood
The Attitudes Toward Motherhood Scale - scores range from 0 to 60, with higher score indicating more dysfunctional or rigid beliefs regarding motherhood
Time frame: baseline, post-test (immediately following the third group meeting and the completion of the five mandatory modules), and one-month follow-up (one month after program completion)
Psychological flexibility
The 7-item Acceptance and Action Questionnaire-II - scores range from 7 to 49, with higher scores indicating greater psychological inflexibility, experiential avoidance, and more potential psychological distress. Lower total scores mean more psychological flexibility.
Time frame: baseline, post-test (immediately following the third group meeting and the completion of the five mandatory modules), and one-month follow-up (one month after program completion)
Satisfaction with the program
The Client Satisfaction Questionnaire - scores range from 8 to 32, with higher scores indicating greater satisfaction
Time frame: post-test (immediately following the third group meeting and the completion of the five mandatory modules)
Completion rate
Percentage of participants who completed at least 5 modules
Time frame: post-test (immediately following the third group meeting and the completion of the five mandatory modules)
Plan to share: Yes — All collected data via questionnaires will be shared in an anonymized manner. The audio recordings from the interviews and the transcripts will not be provided.
Supporting information: Study protocol, Informed consent form
Time frame: After the manuscript will be published.
Started Oct 2026 (actual). Primary completion is estimated for Feb 2027, 4 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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