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Terapia comportamentale cognitiva fornita da Internet per la depressione e l'ansia nei genitori perinatali

2 novembre 2026 aggiornato da: University of Regina

Ottimizzazione della terapia comportamentale cognitiva detenuta da Internet guidata da terapeuta per i genitori nuovi e in attesa

This study evaluates the effectiveness of the Wellbeing Course for New and Expecting Parents (WCNEP), an internet-delivered cognitive behavioral therapy (ICBT) intervention, in reducing symptoms of anxiety and depression in perinatal parents, within a routine care online therapy clinic (the Online Therapy Unit). The study aims to assess treatment uptake, perceptions, feasibility, and effectiveness of the WCNEP in routine care among birthing and non-birthing parents. Over the duration of 8 weeks, participants will review course materials online and respond to questionnaires aimed at assessing changes in various outcomes over time.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Depression and anxiety in the perinatal stage are associated with adverse outcomes such as pregnancy and birth complications, developmental impacts on the baby, relationship issues and poor wellbeing with the partner. Despite these challenges, barriers such as stigma and shame, poor understanding and awareness of symptoms, and lack of treatment availability prevent access to treatment.

Internet-delivered cognitive behaviour therapy (ICBT) is an effective and accessible treatment. The Online Therapy Unit (OTU) routinely delivers ICBT programs for various concerns to Saskatchewan residents. ICBT programs offered by OTU have shown great success, particularly in addressing symptoms of depression and anxiety. Furthermore, previous trials conducted by OTU - Maternal Depression Online and Wellbeing Course for New Moms - have demonstrated the effectiveness of the programs in addressing postnatal depression and anxiety among birthing parents.

Despite the effectiveness of these programs, they were limited in scope; Maternal Depression Online was primarily designed to address depression, and both programs were offered exclusively to postnatal birthing parents. Accordingly, the Wellbeing Course for New and Expecting Parents (WCNEP) has been developed as an 8-week transdiagnostic ICBT program for perinatal birthing and non-birthing parents experiencing depression and/or anxiety. To develop the WCNEP, the Wellbeing Course for New Moms was adapted for parents across the perinatal stage by revising the program content and incorporating additional patient stories of perinatal birthing and non-birthing parents.

Although recruitment and service provision will include both birthing and non-birthing perinatal parents, the Course will be evaluated in two phases. In phase 1, the investigators will evaluate the Course for perinatal birthing parents. In phase 2, the investigators will evaluate the course for non-birthing parents. Prospective clients may learn about the WCNEP from advertisements to the public, healthcare providers, and community organizations. Interested clients will be directed to the study website to complete a screening protocol. Clients will subsequently book and complete a telephone screening with an OTU therapist. Following the telephone screening, eligible clients will be enrolled in the WCNEP. Participants will have access to five lessons that they will complete in consecutive order with 1 to 2 weeks between lessons. They will be asked to complete questionnaires at various time points, and provided with homework activities to complete after each lesson. Participants will also have access to therapist support for a minimum of 8 weeks, which can be extended up to 12 weeks in the event that the birth of a child or some unexpected event occurs during the duration of the Course. After completing treatment, a subset of participants will take part in a semi-structured interview for feedback on overall course content and specific course components (i.e., patient stories).

The overall goals of the study are to evaluate the effectiveness of the intervention on various outcomes in perinatal parents over time, and the uptake of and engagement with different components (e.g., patient stories) of the treatment.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4S 0A2
        • Reclutamento
        • Online Therapy Unit
        • Contatto:
        • Investigatore principale:
          • Heather Hadjistavropoulos, PhD
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Become the guardian of an infant in the last 24 month by birth or adoption/fostering or are expecting the birth of an infant as a birthing parent or partner;
  • Self-reported difficulty with depression and/or anxiety;
  • Are aged 18 years or older; or 16 if participant meets criteria to be treated as a mature minor based on Saskatchewan legislation;
  • Willingness to learn information and skills to self-manage mental health difficulties, consent to course and associated research.

Exclusion Criteria:

  • Current severe medical or psychiatric condition that requires immediate treatment (e.g. current mania or psychosis, actively suicidal or unable to keep themselves safe, medical condition requiring immediate surgery or other invasive treatment);
  • Living outside of Saskatchewan;
  • Unable to read and understand English. (All content is provided in English and staff is English speaking; it is cost prohibitive at this time to provide the complete service in languages other than English).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Wellbeing Course for New and Expecting Parents

Participants in the current study will be perinatal parents experiencing symptoms of depression and/or anxiety. All participants will have access to 5 ICBT lessons released gradually over 8 weeks. The 5 ICBT lessons target challenges and symptoms of anxiety and depression in perinatal parents and focus on: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure; and 5) relapse prevention. Materials are text-based with visual images, and are presented as slideshows, stories, homework reflections, and additional resources.

The Wellbeing Course for New and Expecting Parents (WCNEP) is an adaptation of the Wellbeing Course (developed and evaluated at Macquaire University, Australia) and the Wellbeing Course for New Moms (a Canadian adaptation of the Wellbeing Course for new moms). The WCNEP is a transdiagnostic ICBT intervention designed for perinatal parents experiencing depression and/or anxiety, and will be offered by the Online Therapy Unit, a unit providing routine care ICBT services in Canada. The WCNEP will be evaluated in phases; phase 1 will evaluate the course for birthing parents only and phase 2 will evaluate the course for birthing and non-birthing parents. Therapist support will be offered for 8 weeks, with the possibility to extend the support to 12 weeks. Therapists will spend ~15 minutes/week communicating with each client, via secure messages. Phone calls will only be made if there is a significant clinical issue requiring attention that the therapist feel cannot be addressed in messages.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Edinburgh Postnatal Depression Scale (EPDS)
Lasso di tempo: Baseline (Screening), weeks 1-8, and 20 weeks from enrollment

Tracking the change in depression symptoms. 10 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed with total scores ranging from 0 to 30. Higher scores are associated with higher depression severity.

Baseline (Screening), weeks 1-8, and 20 weeks from enrollment
Generalized Anxiety Disorder 7-item (GAD-7)
Lasso di tempo: Baseline (Screening), weeks 1-8, and 20 weeks from enrollment

Tracking the change in anxiety symptoms. 7 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.

Baseline (Screening), weeks 1-8, and 20 weeks from enrollment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Shortened Postpartum Bonding Questionnaire (S-PBQ)
Lasso di tempo: Baseline (Screening), week 8 and 20 weeks from enrollment

Tracking the change in postnatal birthing parents' bonding with their baby. 10 items are measured on a 5-point Likert scale, ranging from 1-5. Scores are summed into a total score ranging from 10 to 50, with higher scores indicating greater self-reported difficulties in bonding with baby. Administered to postnatal parents only.

Baseline (Screening), week 8 and 20 weeks from enrollment
UCLA 3-Item Loneliness Scale
Lasso di tempo: Baseline (Screening), week 8 and 20 weeks from enrollment

Measures loneliness. 3 items are measured on a 3-point Likert scale ranging from 1-3. Scores are summed into a total score ranging from 3 to 9, with higher scores indicating higher levels of perceived loneliness.

Baseline (Screening), week 8 and 20 weeks from enrollment
Multidimensional Scale of Perceived Social Support (MSPSS)
Lasso di tempo: Baseline (Screening), Week 8, 20 weeks from enrollment

A 12-item measure with three subscales measuring perceived social support from friends, family and significant other. Each subscale contains 4-items. Items on each subscale are measured on a 7-point Likert scale, ranging from 1-7. Subscale scores range from 4 to 28 each, with higher scores indicating greater perceived social support in each category. Global scores range from 12 to 84, with higher scores indicating greater perceived social support overall.

Baseline (Screening), Week 8, 20 weeks from enrollment
Treatment and Story Reflection Questionnaire
Lasso di tempo: Weeks 2 to 8

Measures clients' week-to-week experience in the Wellbeing Course for New and Expecting Parents, and feedback on patient stories. This 10-item measure has been developed by the research team, and contains three subscales. Three items measured on a 7-point Likert scale ranging from 1-7 will be summed into a total score between 3 to 21 to reflect engagement with the treatment, with higher scores indicating greater engagement. Four items (three measured on an 8-point Likert scale ranging from 0-7, and one measured on a 6-point Likert scale ranging from 0-5) will be summed into a total score between 0 to 26 to reflect engagement with patient stories over the past week. Higher scores indicate greater engagement with patient stories. The remaining three items do not have a sum scores, and are used to inquire about which lesson and resources clients worked on, and client success and challenges over the previous week.

Weeks 2 to 8
Treatment Satisfaction Questionnaire
Lasso di tempo: Week 8

A 15-item questionnaire used to assess satisfaction with treatment and negative effects experienced by clients during treatment. The questionnaire utilizes a combination of Likert-scale (5-point (0-4)and 6-point (0-5) ), open-ended, and dichotomous yes/no response options to gauge participants' perception of the course. The questionnaire has been developed by the research team and does not have scoring at this time.

Week 8
Additional Resources Questionnaire
Lasso di tempo: Week 8

A 4-item measure of clients' opinions of and satisfaction with the 11 additional resources offered alongside the Wellbeing Course for New and Expecting Parents. The questionnaire utilizes a combination of dichotomous yes/no (1-item), checklist (2-items), and open-ended (1-item) response option to understand which additional resources participants reviewed and their perception of the resources. The questionnaire was developed by the research team and no score is calculated or created.

Week 8
Credibility/Expectancy Questionnaire (CEQ)
Lasso di tempo: Baseline (Screening) and week 4

Measures treatment credibility and expectancy using 6 items, with two subscales. Each subscale contains 3-items. The first three items of the scale (credibility subscale) are measured on a 1-9 point Likert scale, with scores ranging from 3 to 27 on this subscale. The three items of the expectancy subscale are measured on a 9-point Likert scale ranging from 1 to 9. These items are summed to produce a subscale score ranging from 1 to 27. Higher scores in each sub-scale indicate greater treatment credibility or treatment expectancy respectively.

Baseline (Screening) and week 4
Semi-Structured Interview
Lasso di tempo: After week 8

A semi-structured interview to gather feedback on the treatment and specific treatment components (i.e., patient stories). The number of participants to be interviewed will be determined based on the saturation of themes yielded within preliminary qualitative analyses. The semi-structured interview questions were developed by the research team.

After week 8

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Investigatori

  • Investigatore principale: Heather Hadjistavropoulos, PhD, University of Regina

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 febbraio 2025

Completamento primario (Stimato)

30 giugno 2027

Completamento dello studio (Stimato)

30 giugno 2027

Date di iscrizione allo studio

Primo inviato

11 marzo 2025

Primo inviato che soddisfa i criteri di controllo qualità

11 marzo 2025

Primo Inserito (Effettivo)

18 marzo 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 985

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .