- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07577947
Health And Response: Digital Markers for Outcomes in Perinatal Depression Treatment Study (HARMONY)
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Eliza Congdon, PhD
- Numero di telefono: (310)-339-9053
- Email: harmonystudy@mednet.ucla.edu
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 90095
- University of California, Los Angeles
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Investigatore principale:
- Nelson Freimer, MD
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Contatto:
- Eliza Congdon
- Numero di telefono: (310)-339-9053
- Email: harmonystudy@mednet.ucla.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- At least 18 years of age
- Able to read and communicate in English
- Between 28 weeks pregnant and 12 weeks postpartum
- Moderate-to-severe depression, as defined by Edinburgh Postnatal Depression Scale (EPDS) score ≥11
- Not currently seeing a provider for mental health care
- Own functioning iOS smartphone (iPhone 11 or newer, iOS 18 or newer) with access to reliable data plan and Wifi)
- Able to read and understand a written informed consent form
- Willingness to participate in treatment through the study and follow all study procedures, including providing HIPAA Authorization for research, installing a study app on personal iPhone, and wearing the provided Apple Watch for at least 20 hours every day in the first four weeks of the study (including while sleeping)
Exclusion Criteria:
- Currently receiving treatment by a therapist or a psychiatrist
- Unstable suicidality (e.g., 2 or more suicide attempts or self-injurious behaviors resulting in hospitalization in the last 6 months)
- Current substance use disorder that interferes with treatment: specifically, patients meeting diagnostic criteria for Substance Use Disorder (SUD) will be eligible for inclusion only if they are able to attend sessions while not under the influence of that substance, with the exception of individuals abusing opiates or freebase cocaine, who will be excluded
- Principal diagnosis of psychosis unrelated to depression (unipolar or bipolar)
- Neurological conditions
- Severe uncontrolled medical conditions (e.g., anorexia nervosa, cardiac conditions requiring continuous monitoring)
- Cognitive impairment (e.g., developmental disability, dementia)
- Previously participated in the UCLA Depression Grand Challenge "New Moms Mood Tracking & Wellbeing Study" (IRB #20-001924)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Tier 2 - PND Digital Therapy with Coaching
Participants with a recent EPDS score in the moderate range (11-18) and no current suicidality will be given access to a perinatal depression online cognitive-behavioral therapy course (the ParentMood program).
Some of the lesson content is presented as illustrated videos.
Following each lesson, participants can download a document that summarizes the key information in each lesson, and which includes practical homework exercises that reinforce the content of the lesson.
Participants are encouraged to practice their lesson homework for at least one week before starting the next lesson.
Lessons will be completed sequentially.
Participants have the option of accessing the content through a web-browser.
Participants may receive up to 9 coaching sessions with their assigned Coach, in addition to an initial Orientation session, which will occur through secure video conference.
The initial Orientation session is required, but the additional coaching sessions thereafter are optional.
|
Participants with a recent EPDS score in the moderate range (11-18) and no current suicidality will be given access to a perinatal depression online cognitive-behavioral therapy course (the ParentMood program).
Some of the lesson content is presented as illustrated videos.
Following each lesson, participants can download a document that summarizes the key information in each lesson, and which includes practical homework exercises that reinforce the content of the lesson.
Participants are encouraged to practice their lesson homework for at least one week before starting the next lesson.
Lessons will be completed sequentially.
Participants have the option of accessing the content through a web-browser.
Participants may receive up to 9 coaching sessions with their assigned Coach, in addition to an initial Orientation session, which will occur through secure video conference.
The initial Orientation session is required, but the additional coaching sessions thereafter are optional.
|
|
Comparatore attivo: Tier 3 - Clinical Care
Participants with a recent EPDS score in the severe range (19-30) and/or significant suicidality with intent or means will be given access to a clinical care, which entails weekly psychotherapy sessions. The number and schedule of psychotherapy sessions in the study is determined by the clinical care team. Treatment appointments will occur through secure video conference. If the clinical team believes that consultation with a psychiatrist is warranted, a referral will be made to a UCLA Health clinic (e.g., the MOMS Clinic) for a consultation session and possible pharmacotherapy. |
Participants with a recent EPDS score in the severe range (19-30) and/or significant suicidality with intent or means will be given access to a clinical care, which entails weekly psychotherapy sessions.
The number and schedule of psychotherapy sessions in the study is determined by the clinical care team.
Treatment appointments will occur through secure video conference.
If the clinical team believes that consultation with a psychiatrist is warranted, a referral will be made to a UCLA Health clinic (e.g., the MOMS Clinic) for a consultation session and possible pharmacotherapy.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Edinburgh Postnatal Depression Scale (EPDS) total score
Lasso di tempo: From enrollment through the twelve weeks of the study.
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Self-reported depression symptom severity scores
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From enrollment through the twelve weeks of the study.
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Percent change in EPDS scores
Lasso di tempo: From enrollment through the twelve weeks of the study.
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Percent change in self-reported depression symptom severity scores (as measured with EPDS)
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From enrollment through the twelve weeks of the study.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Treatment retention, as defined by number of coaching or therapy sessions attended by participants
Lasso di tempo: From week 2 through week 13 of the study
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Measure of treatment retention, as defined by number of coaching or therapy sessions attended.
A participant is considered to have been retained in treatment if they completed number of sessions advised by their therapist, or to have not been categorized as dropping from treatment early.
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From week 2 through week 13 of the study
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Treatment retention, as defined by whether the participant completed treatment or not
Lasso di tempo: From week 2 through week 13 of the study
|
Measure of treatment retention, as defined by whether the participant completed treatment or not
|
From week 2 through week 13 of the study
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Michelle G Craske, PhD, University of California, Los Angeles
- Investigatore principale: Nelson Freimer, MD, University of California, Los Angeles
Studiare le date dei record
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
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
- 25-2121
Informazioni su farmaci e dispositivi, documenti di studio
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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 .
Prove cliniche su Perinatal depression online cognitive-behavioral therapy course
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