CORAL Study: Proof of Concept Trial

NCT01379014 | Unknown

• 1 other identifier: 11/EE/0156
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Illness

Keywords

Decisional conflict; Disclosure; Mental Health history; Mental health service users; Decision Aid Tool; Vocational Specialists

Outcome Measures

Primary Outcomes (1)

• decisional conflict scale

  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.

  Change from baseline in decisional conflict at 3 months

Secondary Outcomes (11)

• Sociodemographic data

  baseline

• Employment related questions

  baseline and 3-month follow up

• Discrimination and Stigma Scale (DISC)

  Baseline and 3-month follow-up

• Questionnaire on Anticipated Discrimination (QUAD)

  baseline and 3 month follow-up

• Boston University Empowerment Scale (BUES)

  baseline and 3 month follow-up

Study Arms (2)

Decision Aid Tool

EXPERIMENTAL

Intervention group - receives the decision aid tool in booklet form and is introduced to it by an investigator.

Behavioral: Decision Aid Tool

Control

NO INTERVENTION

The control group does not receive a copy of the decision aid tool booklet, instead received treatment as usual from vocational specialist

Other: Treatment as Usual

Interventions

Decision Aid Tool BEHAVIORAL

A booklet which outlines to pros and cons of different decision outcomes, and is designed to assist the user in making a decision according to their own specific circumstances

Decision Aid Tool

Treatment as Usual OTHER

The control group does not receive a copy of the decision aid tool booklet, instead received treatment as usual from vocational specialist

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Insufficient English to use the decision aid tool
• Lack of capacity to provide informed consent

Sponsors & Collaborators

• Institute of Psychiatry, London: lead

Study Sites (1)

Institute of Psychiatry, King's College London

London, SE5 8AF, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 24072755 DERIVED

• 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.

  PMID: 22938019 DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

Therapeutics

Study Officials

• Graham Thornicroft, FRCPsych

  Institute of Psychiatry, London

  STUDY DIRECTOR

Central Study Contacts

Claire Henderson, MRCPsych

CONTACT

02078485075; claire.1.henderson@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Claire Henderson

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 23, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 2, 2011

Record last verified: 2011-11

Locations

GB (1)