A Randomised Controlled Cross-over Feasibility Trial of a Self-guided Smartphone App to Support Psychological Adjustment in Long-term Physical Conditions Compared to Usual Charity Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- Recruitment
研究概览
简要总结
This study is a two-arm, randomised controlled cross-over feasibility study with a nested, optional qualitative study. The intervention consists of a self-guided smartphone app (Orbi) based on cognitive behavioural therapy (CBT) principles, which is designed to support psychological adjustment in long-term physical conditions. Orbi is an app adaption of an existing, evidence-based web-based intervention COMPASS. The control condition consists of usual charity support (UCS) for the relevant long-term physical health conditions (LTCs). All charity support includes a helpline which can be accessed via telephone or email.
The goal of this trial is to evaluate the feasibility of Orbi and the main questions it aims to answer are:
- Is Orbi a feasible and acceptable intervention for individuals experiencing psychological distress related to LTCs?
- Which aspects of the Orbi app and the trial enhance or diminish participants' experiences?
Participants will:
- Be randomised and each participant has an equal (50 %) chance of being assigned either to the Orbi+UCS group or to UCS group alone for 12 weeks. After 12 weeks, they will be crossed over to the alternate condition for another 12 weeks
- Complete questionnaires to assess psychological distress and intervention engagement at baseline, 6 weeks, and 12 weeks.
- A subset of participants will be invited to take part in a nested, optional semi-structured interviews to explore their experiences using Orbi and participating in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18-years
- •Verbal and written proficiency in English
- •United Kingdom resident (General Practitioner registered)
- •Basic computer literacy
- •Email address to register with Orbi
- •Have a long-term physical health condition
- •Are experiencing distress related to their long-term physical condition
排除标准
- •Evidence of substance dependency, cognitive impairment, severe mental health conditions identified by adhering to usual care Improving Access to Psychological Therapies (IAPT) screening practices that are employed at assessment and triage
- •Those with evidence of severe depression and/ or anxiety scoring over 6 on the Patient Health Questionnaire-4 (PHQ-4) eligibility questionnaire or scoring 1 or above on the eligibility Patient Health Questionnaire-9 (PHQ-9) suicide risk question
- •Receiving active psychological treatment from psychologist/counsellor/therapist or online psychological intervention
研究组 & 干预措施
Usual Charity Support (UCS)
Participants randomised to this condition access Usual Charity Support (UCS) for their long-term physical condition(s). Resources provided by the charities include supportive listening, online support groups, information resources and local community support groups.
Orbi + Usual Charity Support (UCS)
Participants randomised to this condition receive access to a self-guided smartphone app (Orbi) based on cognitive behavioural therapy principles in addition to Usual Charity Support (Orbi + UCS) to support Psychological Adjustment in long-term physical conditions.
干预措施: Orbi (Device)
结局指标
主要结局
Recruitment
时间窗: At baseline
Frequencies and percentages of the number of potential participants recruited to the study
Retention
时间窗: At baseline, 6 weeks (mid-study) and 12 weeks (end of study)
Frequencies and percentages of the number of participants retained in the study
Reach
时间窗: At baseline
Frequencies and percentages of recruited participants who are from under-represented ethnic groups for research conducted in the United Kingdom (e.g. ethnic groups other than white British)
Acceptability
时间窗: 6 weeks (mid-study) and 12 weeks (end of study)
Quantitative: Frequencies and percentages or means and standard deviations of the Theoretical Framework of Acceptability (TFA) questionnaire Qualitative: Framework Thematic Analysis
次要结局
- App usability(6 weeks (mid-study) and 12 weeks (end of study))
- Primary adherence and engagement: App usage data(6 weeks (mid-study) and 12 weeks (end of study))
- Compare post intervention scores on Illness Related Distress (IRD) scale adjusting for baseline differences between groups(At baseline, 6 weeks (mid-study) and 12 weeks (end of study))
- Compare post intervention scores on Work and Social Adjustment Scale (WSAS) adjusting for baseline differences between groups(At baseline, 6 weeks (mid-study) and 12 weeks (end of study))
- Compare post intervention scores on Patient Enablement Instrument (PEI) adjusting for baseline differences between groups(6 weeks (mid-study) and 12 weeks (end of study))
- Compare post intervention scores on Patient Global Impression of Improvement (PGI-I) adjusting for baseline differences between groups(6 weeks (mid-study) and 12 weeks (end of study))
- App usability(6 weeks (mid-study) and 12 weeks (end of study))
- Compare post intervention scores on Patient Enablement Instrument (PEI) adjusting for baseline differences between groups(6 weeks (mid-study) and 12 weeks (end of study))
- Compare post intervention scores on Patient Global Impression of Severity (PGI-S) adjusting for baseline differences between groups(At baseline, 6 weeks (mid-study) and 12 weeks (end of study))
- Compare post intervention scores on Patient Global Impression of Improvement (PGI-I) adjusting for baseline differences between groups(6 weeks (mid-study) and 12 weeks (end of study))
- Comparison between intervention and control groups on Health Service Utilisation(At baseline, 6 weeks (mid-study) and 12 weeks (end of study))
- Comparison between intervention and control in access of charity services(6 weeks (mid-study) and 12 weeks (end of study))
- Compare post intervention scores on EuroQol 5-Dimension 3-Level Questionnaire (EQ-5D-3L) adjusting for baseline differences between groups(At baseline, 6 weeks (mid-study) and 12 weeks (end of study))
- Primary adherence and engagement: App usage data(6 weeks (mid-study) and 12 weeks (end of study))
- Compare post intervention scores on Illness Related Distress (IRD) scale adjusting for baseline differences between groups(At baseline, 6 weeks (mid-study) and 12 weeks (end of study))
- Compare post intervention scores on Work and Social Adjustment Scale (WSAS) adjusting for baseline differences between groups(At baseline, 6 weeks (mid-study) and 12 weeks (end of study))
- Compare post intervention scores on Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS-15) adjusting for baseline differences between groups(At baseline, 6 weeks (mid-study) and 12 weeks (end of study))
- Compare post intervention scores on Patient Health Questionnaire Scale - (PHQ-8) adjusting for baseline differences between groups(At baseline, 6 weeks (mid-study) and 12 weeks (end of study))
- Compare post intervention scores on Generalised Anxiety Disorder Scale (GAD-7) adjusting for baseline differences between groups(At baseline, 6 weeks (mid-study) and 12 weeks (end of study))