CORAL Study: Proof of Concept Trial — CORAL  

Mental Illness Clinical 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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness

• NCT number: NCT01379014
• Study type: Interventional
• Source: Institute of Psychiatry, London
• Contact: Claire Henderson, MRCPsych
• Phone: 02078485075
• Email: claire.1.henderson@kcl.ac.uk
• Status: Recruiting
• Phase: N/A
• Start date: July 2011
• Completion date: March 2013