The CORAL Study of a Decision Aid Tool Regarding Disclosure of Mental Health Status to an Employer: Proof of Concept Randomised Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- decisional conflict scale
研究概览
简要总结
A decision aid tool (DAT) to assist mental health service users in reaching disclosure decisions in the context of employment was developed in a previous study (IRAS REC ref: 07/Q0706/21). The initial feasibility and acceptability was assessed in a group of 15 mental health service users with mean decisional conflict scores reduced from 51.98 to 35.52 after completion. 60% of participants reported that the DAT was quick to complete, 40% that it was easy, 60% that it was relevant and 80% that they would definitely or probably use it in making disclosure decisions. This current study (CORAL: Proof of concept RCT) aims to determine whether a full randomised controlled trial of the DAT is justifiable and feasible, and to optimise its design. This will consider: 1) effects of the intervention; 2) baseline predictors of disclosure; and 3) exploration of the relationship between use of the DAT and the rate of disclosure.
Eighty people who are on the caseload of a vocational specialist working with people with mental illness will be included in this study. All participants will be receiving treatment from an Improving Access to Psychological Therapies (IAPT) service or a Community Mental Health Team (CMHT). An equal number from each group will be allocated to receive either the DAT intervention or treatment as usual. Individuals from both groups will complete baseline assessment and 3month followup assessments. Those allocated to the intervention will also complete an assessment immediately following the intervention. Qualitative interviews will also be conducted at 3 months with a maximum of 15 people from the intervention group and 6 people from the control group.
详细描述
The principal aims are to determine whether a full randomised controlled trial of the CORAL decision aid tool is justifiable and feasible and to optimise its design. Specific objectives are as follows:
- To examine the effect of the DAT on decisional conflict regarding disclosure both immediately and at 3 months post first use.
- To collect data to inform sample size calculations for the primary outcome measures for use in a future full scale trial(gaining employment and workplace accommodations).
- To test study procedures, including the sample that can be drawn using the inclusion and exclusion criteria; the full time equivalent needed for research assistants to recruit sufficient numbers and carry out the study procedures in the time available; and whether the measure leads to too much respondent burden.
- To pilot the use of a questionnaire on employment and disclosure related activities.
- To test the selected randomisation method, in this case individual level randomisation, including the methods for avoiding and measuring contamination.
- To pilot recruitment and retention methods for service users and vocational specialists.
- To estimate effect sizes and their confidence intervals for employment related activities (proxy outcome measures for gaining employment and workplace accommodations), in order to determine whether a full scale trial is justified.
- To modify the conceptual model
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
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
- •On the caseload of a vocational specialist working with people with mental illness.
- •Referred to the adviser either from an Increased Access to Psychological Therapies or secondary mental health care service.
- •Aged 18 years or older
- •Currently seeking either paid or voluntary employment or interested in seeking paid or voluntary employment
- •Decisional conflict scale score of 37.5 or greater and stage of decision score 1-5
排除标准
- •Insufficient English to use the decision aid tool
- •Lack of capacity to provide informed consent
研究组 & 干预措施
Decision Aid Tool
Intervention group - receives the decision aid tool in booklet form and is introduced to it by an investigator.
干预措施: Decision Aid Tool (Behavioral)
Control
The control group does not receive a copy of the decision aid tool booklet, instead received treatment as usual from vocational specialist
干预措施: Treatment as Usual (Other)
结局指标
主要结局
decisional conflict scale
时间窗: Change from baseline in decisional conflict at 3 months
Decisional conflict scale (O'Connor, 1993) This measures personal perceptions of uncertainty, lack of clarity and effectiveness in decision making. Has 16 items with each rated on a 5 point Likert scale ranging from 0=strongly agree to 4=strongly disagree.
次要结局
- Questionnaire on Anticipated Discrimination (QUAD)(baseline and 3 month follow-up)
- Employment related questions(baseline and 3-month follow up)
- Boston University Empowerment Scale (BUES)(baseline and 3 month follow-up)
- stage of decision making scale(Baseline and 3 month follow-up)
- Internalised Stigma of Mental Illness Scale (ISMI)(Baseline and 3 month follow-up)
- Sociodemographic data(baseline)
- Discrimination and Stigma Scale (DISC)(Baseline and 3-month follow-up)
- Perceived Devaluation and Discrimination Scale (PDD)(Baseline and 3 month follow-up)
- Work Limitations Questionnaire (WLQ)(Baseline and 3 month follow-up (for those in employment only))
- Stigma Coping Orientation Scales(baseline and 3 month follow-up)
- Brief COPE(Baseline and 3-months Follow-up)
研究者
Claire Henderson, MRCPsych MSc PhD
Dr Claire Henderson
Institute of Psychiatry, London