- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04287296
A 12-week Feasibility Trial of a Mental Health Breakfast Show Wakey
Providing Mental Health Support Through an Educational and Entertaining Breakfast Show in the United Kingdom - a 12-week Feasibility Trial of Wakey
Panoramica dello studio
Descrizione dettagliata
Mental health conditions are a considerable burden for patients and health services and have been shown to have social patterning in severity and incidence. Children and adults living in the lowest 20% income bracket are two to three times more likely to develop a mental health condition than those people living in the top 20% bracket. Unemployment, working in jobs with low pay and insecure work have been found to be detrimental to mental health. Mental health services are struggling to cope with demands on services, and unequal access to support is further exacerbating health inequalities.
Digital interventions have been proposed as a solution to address the high demand for mental health support in the context of the crisis in healthcare services. These interventions provide the potential to reduce health disparities, by providing personalised low-cost infinitely reusable resource that can increase access to health interventions. However, these interventions may increase inequity, where access and usability for disadvantaged groups remain barriers. To ensure health inequalities are not further exacerbated, there is a need to develop digital interventions that are appealing and accessible those from lower socioeconomic groups. These are social groups that currently look to entertainment to regulate difficult emotions and for education.
An initial pilot of the 9-minute show was trialled in the United Kingdom with a lower socio-economic group and was well received. The app was advertised through the companies that partner with Lost In TV Audience Services, who has a database of 450,000 people. In the initial pilot 43,000 people opened the email about the app. The live morning breakfast show that ran for two weeks was used by 450 participants. The findings were that 50% watched all 10 shows, 65% said that would download the app "today", 70% said it was easier to get out of bed, 53% saw an increase in life satisfaction, and 67% reported an increase in self-efficacy.
The primary objectives of the feasibility study are:
- To assess how many people download the app in the target population
- To assess participant's engagement with the app over the 12-week trial period
The secondary objectives are:
- To explore efficacy data on Office for National Statistics well-being outcomes, sleep and self-efficacy outcomes and to see if there are any changes throughout the trial
- To explore, quantitatively and qualitatively, participants' experiences of using Wakey!
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Sheffield, Regno Unito
- Method X Studios
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- App users who are at least 18 years old.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: App users
The app users who are at least 18 years old.
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Everyone who has downloaded the app will receive a 9-minute morning show as an alternative to an alarm clock every Mon-Fri for 12 weeks.
The show is presented by a cast of presenters who appeal to the target demographic.
The intervention content is theory and evidence led, drawing on approaches from cognitive and third-wave psychotherapies, positive psychology interventions (such as those based on resilience training and growth mindset), and lifestyle mental health interventions.
Additional content will be provided on the app to support the theory and techniques that are covered in the show.
Fun content will also be posted in an ad-hoc manner that complement the shows or relate to cultural dates and aim to increase engagement.
Wakey! will avoid any polarising topics such as politics, religion and folk science.
There are several features beside the show itself: a moderated live chat between 6-9AM, feedback for users (e.g.
how many days they have seen the show, current energy levels).
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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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Overall engagement
Lasso di tempo: 12 weeks; collected daily (not on weekends) throughout the trial
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Number of episodes (livestream/archived) watched over the 12-week period.
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12 weeks; collected daily (not on weekends) throughout the trial
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in personal well-being
Lasso di tempo: 12 weeks; baseline, then weekly follow-ups until the end of the trial
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UK's national personal well-being measures (used in the Annual Population Survey) about life satisfaction, feeling the things done in life are worthwhile, happiness and anxiety.
The participants are asked to rate the four domains on a scale of 0 ("not at all") to 10 ("completely").
Higher scores indicate higher perception of wellbeing (except for anxiety, where higher scores indicate higher level of anxiety).
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12 weeks; baseline, then weekly follow-ups until the end of the trial
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Change in the ease of getting up in the morning
Lasso di tempo: 12 weeks; baseline, then weekly follow-ups until the end of the trial; as a daily question from Mon-Fri during the trial
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The participants are asked to rate how easy it was to get up this morning on a scale of 0 ("not at all") to 10 ("completely").
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12 weeks; baseline, then weekly follow-ups until the end of the trial; as a daily question from Mon-Fri during the trial
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Change in self-efficacy
Lasso di tempo: 12 weeks; baseline, then weekly follow-ups until the end of the trial
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The participants are asked to assess to what extent they agree with the statement "I can successfully overcome life's daily challenges".
The answers include: strongly agree (1), agree (2), neither agree or disagree (3), disagree (4), strongly disagree (5).
Higher scores indicate lower self-efficacy.
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12 weeks; baseline, then weekly follow-ups until the end of the trial
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Entertainment value of the episode
Lasso di tempo: 12 weeks; daily question from Mon-Fri during the trial
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The participants are asked to rate how entertaining did they find the current episode on a scale of 0 ("not at all") to 10 ("completely").
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12 weeks; daily question from Mon-Fri during the trial
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Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
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
Altri numeri di identificazione dello studio
- Wakey
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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 Benessere mentale
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King's College LondonSouth London and Maudsley NHS Foundation TrustIscrizione su invitoDetenzione in base al Mental Health ActRegno Unito
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Yonsei UniversityCompletatoInfermieri che lavorano presso il Community Mental Health Welfare CenterCorea, Repubblica di