Clinical trial NCT01379014: CORAL Study: Proof of Concept Trial
Official title: The CORAL Study of a Decision Aid Tool Regarding Disclosure of Mental Health Status to an Employer: Proof of Concept Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Illness
Keywords: Decisional conflict
Disclosure
Mental Health history
Mental health service users
Decision Aid Tool
Vocational Specialists
Lead sponsor: Institute of Psychiatry, London
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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:

1. To examine the effect of the DAT on decisional conflict regarding disclosure both immediately and at 3 months post first use.
2. 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).
3. 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.
4. To pilot the use of a questionnaire on employment and disclosure related activities.
5. To test the selected randomisation method, in this case individual level randomisation, including the methods for avoiding and measuring contamination.
6. To pilot recruitment and retention methods for service users and vocational specialists.
7. 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.
8. To modify the conceptual model

Eligibility criteria: Inclusion Criteria:

1. On the caseload of a vocational specialist working with people with mental illness.
2. Referred to the adviser either from an Increased Access to Psychological Therapies or secondary mental health care service.
3. Aged 18 years or older
4. Currently seeking either paid or voluntary employment or interested in seeking paid or voluntary employment
5. Decisional conflict scale score of 37.5 or greater and stage of decision score 1-5

Exclusion Criteria:

1. Insufficient English to use the decision aid tool
2. Lack of capacity to provide informed consent

Primary outcomes:
measure: decisional conflict scale
timeFrame: Change from baseline in decisional conflict at 3 months
Secondary outcomes:
measure: Sociodemographic data
timeFrame: baseline
measure: Employment related questions
timeFrame: baseline and 3-month follow up
measure: Discrimination and Stigma Scale (DISC)
timeFrame: Baseline and 3-month follow-up
measure: Questionnaire on Anticipated Discrimination (QUAD)
timeFrame: baseline and 3 month follow-up
measure: Boston University Empowerment Scale (BUES)
timeFrame: baseline and 3 month follow-up
measure: Internalised Stigma of Mental Illness Scale (ISMI)
timeFrame: Baseline and 3 month follow-up
measure: Perceived Devaluation and Discrimination Scale (PDD)
timeFrame: Baseline and 3 month follow-up
measure: Stigma Coping Orientation Scales
timeFrame: baseline and 3 month follow-up
measure: Brief COPE
timeFrame: Baseline and 3-months Follow-up
measure: Work Limitations Questionnaire (WLQ)
timeFrame: Baseline and 3 month follow-up (for those in employment only)
measure: stage of decision making scale
timeFrame: Baseline and 3 month follow-up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Psychiatry, King's College London
Study officials:
affiliation: Institute of Psychiatry, London
name: Graham Thornicroft, FRCPsych
role: STUDY_DIRECTOR
References:
citation: Henderson C, Brohan E, Clement S, Williams P, Lassman F, Schauman O, Dockery L, Farrelly S, Murray J, Murphy C, Slade M, Thornicroft G. Decision aid on disclosure of mental health status to an employer: feasibility and outcomes of a randomised controlled trial. Br J Psychiatry. 2013 Nov;203(5):350-7. doi: 10.1192/bjp.bp.113.128470. Epub 2013 Sep 26.
citation: Henderson C, Brohan E, Clement S, Williams P, Lassman F, Schauman O, Murray J, Murphy C, Slade M, Thornicroft G. A decision aid to assist decisions on disclosure of mental health status to an employer: protocol for the CORAL exploratory randomised controlled trial. BMC Psychiatry. 2012 Aug 31;12:133. doi: 10.1186/1471-244X-12-133.