- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04386668
Let It Out (LIO) and COVID19: Testing an Online Emotional Disclosure-based Intervention During the COVID19 Pandemic (LIO-C)
Let It Out (LIO) and COVID19: a Randomised Controlled Trial of an Online Emotional Disclosure-based Intervention for Adults During the COVID19 Pandemic
A randomised controlled trial designed to test whether an online expressive writing intervention (LIO-C) can reduce distress for English-speaking adults during the global COVID19 pandemic.
Hypothesis: LIO-C will improve distress (as measured by K10) in adults at 1 week post-intervention compared to a neutral writing control during the COVID19 pandemic.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The world is currently experiencing unprecedented challenges caused by the global coronavirus (COVID19) pandemic. Many countries are enforcing measures to restrict movement of people to reduce the spread of the outbreak, including lock-downs, social distancing and self-isolation. These methods, although necessary to slow the spread of disease, will have negative effects on psychological well-being of large populations. Shortage of health care professionals and measures to restrict interpersonal contact means facilitated psychological interventions will not be feasible for many, at least during the height of the pandemic. There is therefore a need for self-directed psychological interventions that can be practically and quickly implemented online.
Emotional disclosure-based therapies, such as expressive writing (EW), hold potential as low-cost, easy to implement means of support, with minimal requirement for facilitation. In its original format, EW involved writing daily for 15-20 minutes for 3-4 days about a traumatic event. Since its development, it has been adapted in many ways, including writing about positive events and writing about stress from a compassionate stance. There is evidence that such interventions can provide significant psychological and physical benefits in healthy populations and reduce the effects of natural disasters on health and well-being. However, to our knowledge this form of psychological intervention has not been tested during a rapidly evolving crisis or pandemic.
The aim of this study is to test whether an online self-compassion and EW based intervention (LIO-C) can reduce the negative effects of the COVID19 pandemic on health and well-being. The intervention is based on an existing intervention, LIO, that we previously developed for use in advanced disease populations, in collaboration with clinical and health psychologists, and patient and public representatives. For this study, we have adapted the intervention for people living through the current COVID19 pandemic by altering the writing prompts, and translating the intervention to an online hub. As this is an unfacilitated intervention, the instructions involve writing from a compassionate stance to minimise any potential short term negative effects associated with writing about difficult experiences.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Kent
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London, Kent, Royaume-Uni, TN14 6DW
- University College London
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- English speaking adults over the age of 18
- Able to read and write clearly in English
Exclusion Criteria:
- None
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: LIO-C
Participants receive LIO-C writing intervention
|
Participants complete three online 20-minute writing sessions in response to prompts asking them to write about their experiences during the COVID19 pandemic from a self-compassionate perspective
Autres noms:
|
|
Comparateur placebo: Neutral writing control
Participants receive neutral writing control intervention
|
Participants complete three online 20-minute writing sessions in response to neutral writing prompts
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Kessler Psychological Distress Scale (K10)
Délai: 1 week post-intervention
|
10-item self-report distress scale
|
1 week post-intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Kessler Psychological Distress Scale (K10)
Délai: Immediately and 8 weeks post-intervention
|
10-item self-report distress scale
|
Immediately and 8 weeks post-intervention
|
|
Perceived Stress Scale (PSS-10)
Délai: Immediately, 1 week and 8 weeks post-intervention
|
Self-report stress scale
|
Immediately, 1 week and 8 weeks post-intervention
|
|
Pittsburgh Sleep Quality Index (PSQI)
Délai: Immediately, 1 week and 8 weeks post-intervention
|
Self-report sleep scale
|
Immediately, 1 week and 8 weeks post-intervention
|
|
Self-compassion scale (SCS)
Délai: Immediately, 1 week and 8 weeks post-intervention
|
Self-report self-compassion scale
|
Immediately, 1 week and 8 weeks post-intervention
|
|
UCLA Loneliness Scale (UCLA LS)
Délai: Immediately, 1 week and 8 weeks post-intervention
|
Self-report loneliness scale
|
Immediately, 1 week and 8 weeks post-intervention
|
|
Uptake of existing mental health services (MHS)
Délai: Immediately, 1 week and 8 weeks post-intervention
|
Self-report measure of MHS usage
|
Immediately, 1 week and 8 weeks post-intervention
|
|
Mood and meaning
Délai: Immediately after each writing session
|
3-item, 7-point, Likert scale measuring how personal and meaningful participants' felt their writing was and their mood
|
Immediately after each writing session
|
|
Acceptability
Délai: Immediately post-intervention
|
Via an online feedback form
|
Immediately post-intervention
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nuriye Kupeli, Marie Curie Palliative Care Research Department, UCL
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 15281/003
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Critères d'accès au partage IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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