跳至主要内容
临床试验/NCT04280250
NCT04280250Unknown不适用

Can Implementation Intentions Help People Who Are Supported by Secondary and Tertiary Care Mental Health Services to be Less Sedentary and More Physically Active: A Feasibility and Acceptability Study.

University of Manchester0 个研究点目标入组 32 人开始时间: 2020年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
32
主要终点
Acceptability of Intervention Measure (AIM). (Weiner et al, 2017)

研究概览

简要总结

Implementation intentions support people to turn intentions into action, and "Volitional Help-Sheets" are a tool which helps people to form implementation intentions. The study will recruit participants from secondary and tertiary mental health services. The participants will be randomised to one of two groups. Participants in Group 1, the control group, will receive the Volitional Help-Sheet (psychoeducational self-help sheet) but not form implementation intentions. Participants in Group 2, the experimental condition, will use the Volitional Help-Sheet to form implementation intentions. Participants will then complete an acceptability and feasibility measure. At follow up, participants will repeat baseline measures. The feasibility and acceptability of using a Volitional Help-Sheet to form implementation intentions to help people using secondary and tertiary care mental health services to reduce sedentary behaviour will be evaluated.

详细描述

Introduction: Sedentary behaviour is risk factor for developing many health conditions. People with mental health difficulties can be more sedentary and live 10 years fewer than other populations. Implementation intentions support people to turn intentions into action, and Volitional Help-Sheets are a tool which helps people to form implementation intentions, by identifying critical situations and linking these to potential solutions. The feasibility and acceptability of using a Volitional Help-Sheet to help people using secondary and tertiary care mental health services to reduce sedentary behaviour will be evaluated. If Volitional Help-Sheets are feasible and acceptable to use in this population, this will justify further research in this area, as improving physical and psychological health could increase life expectancy.

Design: The study includes two timepoints: baseline and follow up (four weeks post baseline). Participant characteristics/demographics collected at baseline. At both baseline and follow up, all participants will be asked to complete measures of sedentary behaviour, physical activity, well-being, motivation and mental health. Participants will be randomised to one of two groups. Participants in Group 1, the control group, will receive the Volitional Help-Sheet as a psychoeducational self-help sheet, but not form implementation intentions. Participants in Group 2, the experimental condition, will use the Volitional Help-Sheet to form implementation intentions. Participants will then complete an acceptability and feasibility measure. At follow up, participants will repeat baseline measures.

Sample size: Participants will be current service users, recruited from NHS based secondary and tertiary care mental health services. The recruitment of a minimum of 24 participants and a maximum of 32 participants would be considered a feasible two-armed study.

Recruitment: Adults: 18years+, motivated to decrease sedentary behaviour (demonstrated by choosing to make contact with the researcher to indicate an interest in participation in the study), has capacity to consent to study, currently receiving support from any secondary or tertiary care mental health service and English language ability sufficient to be able to meet the requirements of the study.

Procedure: Recruitment posters will be displayed in clinical areas as part of recruitment. Care teams can advise interested participants on how to contact the researcher and support this if required. Participant information sheets will be disseminated to interested parties. Where a service user has informed the researcher of their interest in participating in the study, they will be offered a detailed participant information sheet and consent to contact forms outlining the study, the expected benefits and commitment required, and informed consent forms. Interested participants will be assessed for capacity to consent and eligibility and will begin the randomisation procedure upon booking the baseline assessment appointment. All members of the research team have experience of obtaining informed consent in research and clinical roles.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18+ years old
  • Motivated to decrease sedentary behaviour (demonstrated by choosing to make contact with the researcher to indicate an interest in participation in the study
  • Has capacity to consent to study
  • Currently receiving support from any secondary or tertiary care mental health service
  • English language ability sufficient to be able to meet the requirements of the study
  • Participants will not be recruited on the basis of an assumption that they are sedentary, and participants must demonstrate a desire to increase their sedentary behaviour as indicated by choosing to make contact with the researcher to indicate an interest in participation in the study.

排除标准

  • Cannot give informed consent
  • English language not sufficient to be able to meet the requirements of the study
  • Does not meet other criteria for inclusion

结局指标

主要结局

Acceptability of Intervention Measure (AIM). (Weiner et al, 2017)

时间窗: Change from Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)

Self reported acceptability measure

Intervention Appropriateness Measure (IAM). (Weiner et al, 2017)

时间窗: Change from Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)

Self reported appropriateness measure

Feasibility of Intervention Measure (FIM). (Weiner et al, 2017)

时间窗: Change from Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)

Self reported feasibility measure

次要结局

  • International Physical Activity Questionnaire short form (Booth, 2000)(Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline))
  • Sedentary Behaviour Questionnaire (Gardener et al, 2011)(Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline))
  • CORE-OM (Evans et al, 2000)(Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline))
  • COM-B measures (Keyworth, Epton, Goldthorpe, Calam, and Armitage, 2019)(Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline))
  • Office for National Statistics' Measure of Subjective Wellbeing (Dolan, Layard, and Metcalfe, 2011).(Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie Roebuck

Trainee Clinical Psychologist

University of Manchester

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