- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01901796
Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT) Full Trial
Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT): Intervening Early to Improve Maternal and Family Well-being.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
One of the main reasons that women do not receive treatment is that their mood and anxiety problems are not detected. Despite recommendations and high rates of acceptance by providers and women, only a minority of providers conduct psychosocial assessments as part of routine prenatal care. Computer-based 'screening' is an acceptable and feasible approach to assessment of sensitive issues including prenatal and postnatal intimate partner violence, mental health problems, and postpartum depression by patients and providers. It is well-suited for busy clinical settings and is advantageous in that it offers a consistent approach to assessment, is resource-sparing, can be tailored to meet the specific needs of patients, can be used with audio/video for low literacy, provides a real-time summary for patients/providers,achieves similar or higher rates of disclosure of violence and mental health problems, and is preferred by patients because they perceive it as more anonymous compared to interviews or questionnaires.
However, psychosocial assessment on its own is ineffective in preventing or treating mood disorders and unethical in the absence of treatment options. As such, many providers do not assess pregnant women for mood disorders because non-pharmacological treatments are frequently unavailable and pregnant women prefer them. Cognitive behavioural therapy (CBT) is a highly effective, non-pharmacological treatment for depression and anxiety and is recommended by perinatal national Australian guidelines as a potentially effective EARLY intervention for reducing the risk of maternal-child outcomes.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Alberta
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Stony Plain, Alberta, Canada, T7Z 2M7
- Westview Health Centre
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion criteria:
Pregnant women will be eligible for Phase 2 if they are:
- < 28 weeks gestation (to provide the opportunity to complete 6 modules and follow-up questionnaires prior to delivery)
- able to speak/read English; and (3) willing to complete email questionnaires
Exclusion Criteria:
- >28 weeks gestation
- unable to speak/read English
- unable to complete email questionnaires
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Screening and CBT
Screening and Cognitive Behavioral Therapy.
The intervention group will be screened and if they need criteria they will complete the 6, 30-minute online, interactive CBT modules over 6 weeks.
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Cognitive Behavioral Therapy- an effective, non-pharmacological treatment for depression and anxiety.
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Nessun intervento: Usual care
Usual prenatal care
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components.
Lasso di tempo: 6 weeks post randomization
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Feasibility/acceptability of the intervention will be assessed through individual face-to-face or telephone-based semi-structured qualitative interviews of both clinic staff and women in the intervention group.
The field does not allow for all questions to be provided.
Sample question for clinic staff is 'What aspects made it easy/challenging to use the tablet for prenatal assessment as part of routine prenatal care?' Sample questions for intervention group participants: 1)How did you feel about answering these kinds of questions on a tablet?; 2)Please describe any concerns you had about answering these questions on a tablet; 3)How would you prefer the results to be shared with you
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6 weeks post randomization
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Maternal depression, anxiety, stress
Lasso di tempo: on recruitment, 6 weeks post randomization and 3 months postpartum
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Depression, Anxiety, and Stress Scale (DASS-21) Self-reported by mother on emailed questionnaire
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on recruitment, 6 weeks post randomization and 3 months postpartum
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Maternal coping
Lasso di tempo: on recruitment, 6 weeks post-randomization and 3 months postpartum
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The Brief Cope Self-reported by mother on emailed questionnaire
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on recruitment, 6 weeks post-randomization and 3 months postpartum
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Relationship Adjustment
Lasso di tempo: on recruitment, 6 weeks post-randomization and 3 months postpartum
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Scale: Dyadic Adjustment Scale, DAS-7 Self-reported by mother on emailed questionnaire
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on recruitment, 6 weeks post-randomization and 3 months postpartum
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Parenting Stress
Lasso di tempo: 3 months postpartum
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Parenting Stress Scale Self-reported by mother
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3 months postpartum
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Parenting competence
Lasso di tempo: 3 months postpartum
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Parenting Sense of Competence Scale Self-reported by mother on emailed questionnaire
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3 months postpartum
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Maternal-infant attachment
Lasso di tempo: 3 months postpartum
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Maternal Attachment Inventory (MAI) Self-reported by mother on emailed questionnaire
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3 months postpartum
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Trait anxiety
Lasso di tempo: on recruitment, 6 weeks postrandomization, 3 months postpartum
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State Trait Anxiety Inventory (STAI) Self-reported by mother on emailed questionnaire
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on recruitment, 6 weeks postrandomization, 3 months postpartum
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Dawn A Kingston, Ph.D, University of Calgary
Pubblicazioni e link utili
Pubblicazioni generali
- Bright KS, Stuart S, Mcneil DA, Murray L, Kingston DE. Feasibility and Acceptability of Internet-Based Interpersonal Psychotherapy for Stress, Anxiety, and Depression in Prenatal Women: Thematic Analysis. JMIR Form Res. 2022 Jun 10;6(6):e23879. doi: 10.2196/23879.
- Bright KS, Mughal MK, Wajid A, Lane-Smith M, Murray L, Roy N, Van Zanten SV, Mcneil DA, Stuart S, Kingston D. Internet-based interpersonal psychotherapy for stress, anxiety, and depression in prenatal women: study protocol for a pilot randomized controlled trial. Trials. 2019 Dec 30;20(1):814. doi: 10.1186/s13063-019-3897-z.
- Kingston D, Austin MP, Hegadoren K, McDonald S, Lasiuk G, McDonald S, Heaman M, Biringer A, Sword W, Giallo R, Patel T, Lane-Smith M, van Zanten SV. Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT). Trials. 2014 Mar 6;15:72. doi: 10.1186/1745-6215-15-72.
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Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 00036912
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 .
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