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Postpartum Depression (PPD)Early Phase 1NCT07902141

A Web-based Intervention Program for Postpartum Depression

A Early Phase 1 study testing Web-based program for postpartum depression in people with Postpartum Depression (PPD) and Web-based Intervention, run by Babes-Bolyai University at 1 site in Romania.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study evaluates a Web-based intervention program to treat women with postpartum depression. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Web-based program for postpartum depression
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteRomania
Study dates
27 Oct 2026to Feb 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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

  • at least 18 years old
  • between 1 and 12 months postpartum
  • with postpartum depression symptoms (The Edinburgh Postnatal Depression Scale score above 9 or a Patient Health Questionnaire-9 score above 9)
  • access to a computer or smartphone with internet connection
  • Romanian speaking.

Who cannot join

  • psychotic elements
  • suicidal ideation
  • bipolar disorder
  • substance abuse
  • current psychological treatment for depression

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andreea Astefanei, PhD Candidate contact

+40740753003

andreeaastefanei@psychology.ro

Romania1 site, 1 recruiting

  • Babes-Bolyai University

    Cluj-Napoca, Cluj, 400347

    Andreea Astefanei, PhD Candidate, +40740753003, andreeaastefanei@psychology.ro

    Recruiting

Other trials in Romania

About this study

Official title: A Web-based Intervention Program for Postpartum Depression: A Feasibility and Usability Trial

This study evaluates a Web-based intervention program to treat women with postpartum depression.

Read the detailed description

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.

Being tested
Web-based program for postpartum depression
Keywords
Postpartum Depression, Mood Disorder, Web-Based Intervention, CBT Intervention
Medical subject headings
Depression, Postpartum, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-based program for postpartum depressionDevice

    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.

Study groups in NCT07902141
Study groupRoleWhat they receive
Web-based intervention program for postpartum depressionExperimentalParticipants will receive the online intervention program for postpartum depression.
Receives: Device: Web-based program for postpartum depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Program Usability

    The System Usability Scale - scores can range from 0 (indicating very low perceived usability) to 100 (indicating excellent perceived usability)

    Measured: post-test (immediately following the third group meeting and the completion of the five mandatory modules)

  2. 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

    Measured: 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

  3. 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

    Measured: 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

Secondary outcomes (5)

  1. Postpartum Depression

    The Edinburgh Postnatal Depression Scale - scores range from 0 to 30, with higher scores indicating a higher level of symptom severity

    Measured: 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)

  2. Postpartum Depression

    Patient Health Questionnaire (9-item version) - scores range from 0 to 27, with higher scores indicating a more severe level of symptoms

    Measured: 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)

  3. Anxiety

    Generalized Anxiety Disorder-7 - scores range from 0 to 21, with higher scores indicating a higher level of symptom severity

    Measured: 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)

  4. 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

    Measured: 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)

  5. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2026
  2. Study start27 Oct 2026
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07902141
Sponsor's protocol ID
012607
Status last verified
Oct 2026
First submitted
20 Mar 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Brooke, J. (1996). SUS: A quick and dirty usability scale. In P.W. Jordan, B. Thomas, B. A. Weerdmeester & I. L. McClelland (Eds.), Usability Evaluation in Industry (pp. 189-194). London: Taylor & Francis.

  • Sockol LE, Epperson CN, Barber JP. The relationship between maternal attitudes and symptoms of depression and anxiety among pregnant and postpartum first-time mothers. Arch Womens Ment Health. 2014 Jun;17(3):199-212. doi: 10.1007/s00737-014-0424-9. Epub 2014 Mar 20.

    PubMed 24643422

  • Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

    PubMed 10245370

  • Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.

    PubMed 22035996

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941

  • Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

    PubMed 3651732

  • Aștefanei, A., Miclea, M. Technology-Based Interventions for the Treatment of Peripartum Depression: An In-Depth Systematic Review. Int. J. Cogn. Behav. Ther. 18, 53-93 (2025). https://doi.org/10.1007/s41811-025-00245-4

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Web-based program for postpartum depression in people with Postpartum Depression (PPD) and Web-based Intervention, run by Babes-Bolyai University at 1 site in Romania.

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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andreea Astefanei, PhD Candidate (+40740753003, andreeaastefanei@psychology.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Program Usability (time frame: post-test (immediately following the third group meeting and the completion of the five mandatory modules)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07902141, which also lists 8 linked publications.

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 28 Oct 2026.

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