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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Kent
-
London、Kent、イギリス、TN14 6DW
- University College London
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- English speaking adults over the age of 18
- Able to read and write clearly in English
Exclusion Criteria:
- None
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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
他の名前:
|
プラセボコンパレーター:Neutral writing control
Participants receive neutral writing control intervention
|
Participants complete three online 20-minute writing sessions in response to neutral writing prompts
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Kessler Psychological Distress Scale (K10)
時間枠:1 week post-intervention
|
10-item self-report distress scale
|
1 week post-intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Kessler Psychological Distress Scale (K10)
時間枠:Immediately and 8 weeks post-intervention
|
10-item self-report distress scale
|
Immediately and 8 weeks post-intervention
|
Perceived Stress Scale (PSS-10)
時間枠: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)
時間枠:Immediately, 1 week and 8 weeks post-intervention
|
Self-report sleep scale
|
Immediately, 1 week and 8 weeks post-intervention
|
Self-compassion scale (SCS)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠:Immediately post-intervention
|
Via an online feedback form
|
Immediately post-intervention
|
協力者と研究者
捜査官
- 主任研究者:Nuriye Kupeli、Marie Curie Palliative Care Research Department, UCL
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 15281/003
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有アクセス基準
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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