Mental IllnessCORALNCT01379014
CORAL Study: Proof of Concept Trial
A study testing Decision Aid Tool and Treatment as Usual in people with Mental Illness, run by Institute of Psychiatry, London at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness
- What is being tested?
- Decision Aid Tool and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Insufficient English to use the decision aid tool
- Lack of capacity to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Institute of Psychiatry, King's College London
London, SE5 8AF
About this study
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
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.
Read the 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:
- 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
- Conditions
- Mental Illness
- Being tested
- Decision Aid Tool, Treatment as Usual
- Keywords
- Decisional conflict, Disclosure, Mental Health history, Mental health service users, Decision Aid Tool, Vocational Specialists
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Aid ToolBehavioural
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
Treatment as UsualOther
The control group does not receive a copy of the decision aid tool booklet, instead received treatment as usual from vocational specialist
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid Tool | Experimental | Intervention group - receives the decision aid tool in booklet form and is introduced to it by an investigator. Receives: 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 Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline in decisional conflict at 3 months
Secondary outcomes (11)
Sociodemographic data
Socio-demographic and clinical data to be collected as part of the baseline interview will include age, gender, years since first contact with mental health services, education, employment status and history, housing arrangements, source of income, current mental health care, knowledge of clinical diagnosis, agreement with diagnosis and information on social networks.
Measured: baseline
Employment related questions
To record how many jobs applications, apppointments with vocational specialists, training days and job applications the participant has completed in the preceeding 3 months.
Measured: baseline and 3-month follow up
Discrimination and Stigma Scale (DISC)
scale to assess mental health service users' experiences of discrimination. 22 items. Baseline assesses if discrimination/stigma has ever been experienced, 3 month follow-up asks if discrimination/stigma as been experienced in the past three months.
Thornicroft, G., Brohan, E., Rose, D., Sartorius, N. \& the INDIGO study group. (2009) Global pattern of experienced and anticipated discrimination against people with schizophrenia. The Lancet, 373 (9661), 408-415
Measured: Baseline and 3-month follow-up
Questionnaire on Anticipated Discrimination (QUAD)
The QUAD is a self-complete measure which contains 17 items which address 'areas of anticipated discrimination'. This asks participants to provide a rating of whether they expect to be treated unfairly in various areas of life. Each item is scored on a five point Likert scale ranging from 0 (Strongly disagree) to 4 (Strongly agree).
Brohan E, Clement S, Thornicroft G. Development and initial validation of the questionnaire on anticipated discrimination (QUAD v6, May 2011) © 2011, Institute of Psychiatry, King's College London
Measured: baseline and 3 month follow-up
Boston University Empowerment Scale (BUES)
This 28-item scale was developed with an emphasis on service user-involvement at all stages of design and testing. This version has shown adequate internal consistency (α=.86).
Rogers, E. S., Chamberlin, J., Ellison, M. L., et al (1997) A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatric Services, 48, 1042-1047.
Measured: baseline and 3 month follow-up
Internalised Stigma of Mental Illness Scale (ISMI)
The ISMI is a 29-item measure that assesses mental health service users' experience of internalised stigma. It is composed of 5 sub-scales: Alienation, Stereotype Endorsement, Perceived Discrimination, Social Withdrawal and Stigma Resistance. Strong internal consistency (α = 0.90) and test-retest reliability(r=0.92) have been reported Ritsher JB, Otilingam PG, Grajales M. Internalized stigma of mental illness: Psychometric properties of a new measure. Psychiatry Research 2003;121(1):31-49.
Measured: Baseline and 3 month follow-up
Perceived Devaluation and Discrimination Scale (PDD)
The PDD is a 12-item, uni-dimensional, scale which measures the extent to which a person believes that people will devalue or discriminate against those with a mental illness. This scale has been widely used and has excellent psychometric properties
Link, B.G., Neese-Todd, S., Asmussen, S. \& Phelan, J.C. (2002). On describing and seeking to change the experience of stigma. Psychiatric Rehabilitation Skills, 6: 201-231.
Measured: Baseline and 3 month follow-up
Stigma Coping Orientation Scales
Measures to assess approaches to coping with the stigma associated with mental illness. Revised versions of four of the scales are now available and will be used in this study. These are secrecy (5-items alpha = .85), withdrawal (5-items alpha = .71), challenging (5 items alpha = .75) and distancing (3 items alpha = .62) (Bruce Link, personal communication).
The Effectiveness of Stigma Coping Orientations: Can Negative Consequences of Mental Illness Labeling be Avoided? Bruce G. Link, Jerrold Mirotznik, Francis T. Cullen, Journal of Health and Social Behavior, Vol. 32, No. 3 (Sep., 1991)
Measured: baseline and 3 month follow-up
Brief COPE
A short-version COPE Inventory. Assesses response to stress. 14 scales with two items each; self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion and self-blame. Reliability analyses exceeded alpha=0.60, except for venting, denial and acceptance, all of which exceed alpha = 0.50 (Carver et al 1997)
Carver, C. S. (1997). International Journal of Behavioral Medicine, 4, 92-100
Measured: Baseline and 3-months Follow-up
Work Limitations Questionnaire (WLQ)
The 8-item short WLQ measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss.
Work Limitations Questionnaire, 1998. The Health Institute, Tufts Medical Center, 800 Washington Street, Nemc #345, Boston, MA 02111
Measured: Baseline and 3 month follow-up (for those in employment only)
stage of decision making scale
Stage of decision making scale (O'Connor, 2000).This measures the individual's readiness to engage in decision making It consists of 1 item with 6 response options anchored at 1 (haven't started to think about the choices) and 6 (have already made a decision and am unlikely to change my mind).
Measured: Baseline and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Psychiatry, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Henderson, MRCPsych MSc PhD, Institute of Psychiatry, London
- Investigators
- Graham Thornicroft, FRCPsych, Study director, Institute of Psychiatry, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379014
- Sponsor's protocol ID
- 11/EE/0156
- Acronym
- CORAL
- Status last verified
- Nov 2011
- First submitted
- 17 Jun 2011
- Last updated
- 2 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24072755Henderson 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.
PubMed 22938019
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01379014
- Acronym / sponsor ID
- CORAL / 11/EE/0156
- Conditions
- Mental Illness
- Keywords
- Decisional conflict, Disclosure, Mental Health history, Mental health service users, Decision Aid Tool, Vocational Specialists
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Institute of Psychiatry, LondonUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Aid Tool | Experimental | Behavioral: Decision Aid ToolIntervention group - receives the decision aid tool in booklet form and is introduced to it by an investigator. |
| Control | No intervention | Other: Treatment as UsualThe control group does not receive a copy of the decision aid tool booklet, instead received treatment as usual from vocational specialist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Insufficient English to use the decision aid tool
- Lack of capacity to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision Aid ToolA 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 | Behavioural | Decision Aid Tool |
| Treatment as UsualThe control group does not receive a copy of the decision aid tool booklet, instead received treatment as usual from vocational specialist | Other | Control |
Primary outcome
decisional conflict scale
Time frame: 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.
11 secondary outcomes
Sociodemographic data
Time frame: baseline
Employment related questions
Time frame: baseline and 3-month follow up
Discrimination and Stigma Scale (DISC)
Time frame: Baseline and 3-month follow-up
Questionnaire on Anticipated Discrimination (QUAD)
Time frame: baseline and 3 month follow-up
Boston University Empowerment Scale (BUES)
Time frame: baseline and 3 month follow-up
Internalised Stigma of Mental Illness Scale (ISMI)
Time frame: Baseline and 3 month follow-up
Perceived Devaluation and Discrimination Scale (PDD)
Time frame: Baseline and 3 month follow-up
Stigma Coping Orientation Scales
Time frame: baseline and 3 month follow-up
Brief COPE
Time frame: Baseline and 3-months Follow-up
Work Limitations Questionnaire (WLQ)
Time frame: Baseline and 3 month follow-up (for those in employment only)
stage of decision making scale
Time frame: Baseline and 3 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
- Derived from this study: PubMed 24072755Henderson 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.
- Derived from this study: PubMed 22938019Henderson 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.
- Institute of Psychiatry homepageLink provided by the sponsor.
Related trials for Mental Illness
Not yet recruiting
FUS Neuromodulation for Binge Eating Disorder
Binge-Eating Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham Thornicroft, FRCPsych study director
Institute of Psychiatry, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid Tool and Treatment as Usual in people with Mental Illness, run by Institute of Psychiatry, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Henderson, MRCPsych (02078485075, claire.1.henderson@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decisional conflict scale (time frame: Change from baseline in decisional conflict at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01379014, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2011.