Cognitive-behavioural therapy smartphone app for low mood and worry management in female armed forces veterans in Great Britain: protocol for a feasibility randomised controlled trial

针对英国女性退伍军人的低落情绪和焦虑管理,开发了一款认知行为疗法智能手机应用程序:一项可行性随机对照试验方案

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Abstract

INTRODUCTION: Emotional difficulties, such as low mood and worry, are more prevalent among female forces veterans compared to their male peers. However, female veterans are more reluctant to access mental health services available for armed force veterans. To enhance help seeking, the Iona female forces veterans (IonaFFV) research app has been developed and adapted for low mood and worry management among female veterans. This feasibility randomised controlled trial primarily seeks to explore the methodological uncertainties of conducting a definitive randomised controlled trial using IonaFFV. Secondary aims seek to explore acceptability and engagement with IonaFFV. Additionally, progression criteria will be assessed to determine feasibility of moving to a definitive trial. METHODS AND ANALYSIS: Participants were recruited online and asked to complete two screening assessments to assess eligibility. Eligible participants were randomised using block randomisation to use either the IonaFFV or Iona sham app for 6 weeks. Recruitment and randomisation are complete, and data collection is currently ongoing. At the end of the 6-week intervention period, participants will complete the Patient Health Questionnaire-9, the Generalised Anxiety Disorder-7 and Work and Social Adjustment Scale outcome measures. At 4 weeks postintervention (10 weeks postrandomisation), participants will complete the same outcome measures in addition to the mHealth App Usability Questionnaire (MAUQ) to assess acceptability of both IonaFFV and Iona sham. At the end of the study, the participants who were in the Iona sham group will be given an option to use the IonaFFV app for 6 weeks. Proportions will be reported for feasibility and demographic data with descriptive analysis conducted for the outcome measures. Median values with IQRs will be conducted for each subscale of MAUQ. ETHICS AND DISSEMINATION: This study received ethical approval from the University of Exeter Psychology Ethics Committee with consent obtained from all participants. Study findings will be published in peer-reviewed journals, presented at conferences, with a final report presented to the funders of the project. TRIAL REGISTRATION NUMBER: ISRCTN50744553.

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